geneproof catalogue · 2018. 10. 25. · your specialist for pcr diagnostics! molecular diagnostics...

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www.geneproof.comwww.geneproof.com

Molecular diagnostics for your routine

2018

GeneProof a.s. Vídeňská 101/119

619 00 BrnoCzech Republic

+420 543 211 679 PHONE

+420 516 770 824 FAX

[email protected] E-MAIL


PRODUCT CATALOGUE

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2018


Dolní Heršpice619 00 Brno

+420 543 211 679 TEL

+420 516 770 824 FAX



KATALOG PRODUKTŮ

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Our mission is to provide our customers with technologically advanced solutions

in the field of molecular in vitro diagnostics and to be their reliable partner

in the common effort to continuously improve health care.

Our vision is a global company capable of satisfying a wide range of diagnostic 

requirements from flexible POC systems to automated high-throughput solutions. 

We believe that with the development of technology, we can move our reliable and 

accurate routine diagnostics closer to the patient.

Our strategy is to maximize the use of modern technologies enabling the automation 

of the diagnostic process. The high expertise of our R&D staff, together with the state 

of the art laboratory facilities, enable us to continuously innovate and expand 

the product portfolio and thus respond flexibly to changes in the form of newly 

emerging mutations and pathogens. We want to further strengthen the cooperation 

with end-customers and distributors in order to satisfy their needs and offer advanced 

products complying with demanding legislative requirements.

GeneProof a.s. is a biotechnological company operating in the field of molecular in vitro diagnostics of serious infectious and genetic diseases.

The focus of GeneProof on product quality and end-users makes our products an unmatched economical solution for small, medium and large laboratories.

RESPIRATORY INFECTIONS

SEXUALLY TRANSMITTED INFECTIONS

TROPICAL INFECTIONS & ZOONOSES

GASTROINTESTINAL INFECTIONSBLOODBORNE INFECTIONS

ANTIBIOTIC RESISTANCE

TRANSPLANTATION INFECTIONS FUNGAL INFECTIONS

ONCOGENETIC DIAGNOSTICS RNA EXTRACTIONS

THROMBOTIC MUTATIONS

croBEE NA croBEE RT

DNA EXTRACTIONSPHARMACOGENETICS

PRENATAL DIAGNOSTICS

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/ MOLECULAR DIAGNOSTICS

/ INSTRUMENTS

/ MOLECULAR DIAGNOSTICS

MICROBIOLOGICAL DIAGNOSTICS

Microbiological RNA DiagnosticsMicrobiological RNA Diagnostics Technology   7GeneProof Hepatitis C Virus (HCV) PCR Kit    8GeneProof HIV type 1 (HIV-1) PCR Kit    9GeneProof Enterovirus PCR Kit  IN DEVELOPMENT  10

Microbiological DNA DiagnosticsMicrobiological DNA Diagnostics Technology  11GeneProof Hepatitis B Virus (HBV) PCR Kit   12GeneProof BK/JC Virus (BK/JC) PCR Kit   13GeneProof BK Virus (BKV) PCR Kit   14GeneProof JC Virus (JCV) PCR Kit   15GeneProof Cytomegalovirus (CMV) PCR Kit   16GeneProof Epstein-Barr Virus (EBV) PCR Kit   17GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit   18GeneProof Herpes Simplex Virus 2 (HSV-2) PCR Kit   19GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit   20GeneProof Varicella-Zoster Virus (VZV) PCR Kit   21GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit  NEW PRODUCT  22GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit  NEW PRODUCT  23GeneProof Parvovirus B19 PCR Kit  NEW PRODUCT  24GeneProof Adenovirus PCR Kit   25GeneProof Aspergillus PCR Kit   26GeneProof Borrelia burgdorferi PCR Kit   28GeneProof Neisseria gonorrhoeae PCR Kit   30GeneProof Chlamydia trachomatis PCR Kit   31GeneProof Human Papillomavirus (HPV) PCR Kit  NEW PRODUCT  32GeneProof Mycoplasma genitalium/hominis PCR Kit   34GeneProof Ureaplasma PCR Kit   35GeneProof Bordetella pertussis/parapertussis PCR Kit   36GeneProof Chlamydia pneumoniae PCR Kit   37GeneProof Legionella pneumophila PCR Kit   38GeneProof Mycobacterium tuberculosis PCR Kit   39GeneProof Mycoplasma pneumoniae PCR Kit   40GeneProof VRE PCR Kit   41GeneProof ESBL PCR Kit   42GeneProof MRSA PCR Kit   43GeneProof CT/NG/MG Multiplex PCR Kit  IN DEVELOPMENT  44

GENETIC DIAGNOSTICS

Genetic Diagnostics Technology  45

Thrombotic MutationsGeneProof Factor II Prothrombin PCR Kit   46GeneProof Factor V Leiden PCR Kit   47GeneProof Factor XIII V34L PCR Kit   48

GeneProof MTHFR C677T PCR Kit   49GeneProof MTHFR A1298C PCR Kit   50GeneProof PAI-1 Genotyping PCR Kit   51

PharmacogeneticsGeneProof Warfarin dose VKORC/CYP2C9 PCR Kit   52

Oncogenetic DiagnosticsOncogenetic Diagnostics Technology  53GeneProof BCR/ABL Detection PCR Kit  NEW PRODUCT  54GeneProof BCR/ABL Major PCR Kit  IN DEVELOPMENT  55GeneProof BCR/ABL Minor PCR Kit  IN DEVELOPMENT  55

Prenatal DiagnosticsPrenatal Diagnostics Technology  57GeneProof OmniPlex QF PCR Kit   58GeneProof OmniPlex 13plus QF PCR Kit   58GeneProof OmniPlex 18plus QF PCR Kit   58GeneProof OmniPlex 21plus QF PCR Kit   58GeneProof OmniPlex XYplus QF PCR Kit   58

NUCLEIC ACID EXTRACTIONS

Manual DNA/RNA Extraction Technology  61

DNA ExtractionsGeneProof PathogenFree DNA Isolation Kit   62

RNA ExtractionsGeneProof PathogenFree RNA Isolation Kit   62

/ INSTRUMENTS

CROBEE

Universal Solution  63

croBEE NAAutomated DNA/RNA Extraction Technology  64croBEE NA16 Nucleic Acid Extraction System   65croBEE 201 A Nucleic Acid Extraction Kit   65

croBEE RTcroBEE Real-Time PCR System   66

Customer Care  67Contacts  67Product List  68

Ready to Use MasterMix• easy manipulation saves time and reduces need for qualified personnel

• low risk of contamination

• high uniformity of results

• high kits stability

All components for amplification and process control are included

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• universal protocol suitable for nucleic acids extraction from different input materials by manual or automatic extraction

• single PCR profile for whole diagnostic groups

• PCR kits are validated for our instrument platform (croBEE) and a broad range of real-time PCR devices from different manufacturers

• GeneProof diagnostics kits are continuously validated on different types of devices and samples. Current overview is available at [email protected]

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• the company has been audited for products by the NB1023 Notified Body according to the Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices

• GeneProof a.s. is EN ISO 13485 certified. The subject of the certification is design, development, manufacturing and sales of in vitro diagnostic medical devices

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• attractive pricing

• the most cost efficient solution

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• theoretical and practical personnel training in molecular diagnostics

• technical and professional support provided to the laboratory needs

• professional consulting of clinical interpretation of the results

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• the kits are regularly tested in External Quality Assessment Panels (QCMD, INSTAND e.V.)

• excellent EQA results

• all GeneProof products are certified

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MOLECULARDIAGNOSTICS

7PRODUCT CATALOGUE | 2018Microbiological RNA Diagnostics

www.geneproof.com

GeneProof Microbiological RNA Diagnostics Technology

ISEX ISEXplus

/ SAMPLE

Internal Standard is added into the sample before the RNA isolation

/ RNA ISOLATION

after the isolation the extracted sample RNA  with the concurrently isolated Internal Standard RNA  are added into the Ready to Use MasterMix and the tube is inserted into the real-time device

MICROBIOLOGICAL DIAGNOSTICS

/ SAMPLE

positive sample contains  viral RNA  control RNA

/ RNA ISOLATION

after the isolation the extracted sample RNA is added into the Ready to Use MasterMix and the tube is inserted into the real-time device

/ RT-PCR AMPLIFICATION

during RT-PCR, viral RNA is amplified from one primer pair  and control RNA amplified from the other primer pair

POSITIVE SAMPLE–   exponential fluorescence growth of the FAM fluorophore 

is evident if the target viral RNA is present in the sample

/ EVALUATION

QUALITY CONTROL FOR THE COMPLETE DIAGNOSTIC PROCESS–   exponential growth of the HEX fluorophore fluorescence, as 

a result of the control RNA amplification, controls the following:

1.  sample quality – sample RNA (and therefore also the viral RNA) was not degraded

2.  RNA extraction quality – sample RNA was isolated with sufficient efficiency

3.  RT-PCR amplification quality – sample RNA was efficiently amplified, no PCR inhibition

8 PRODUCT CATALOGUE | 2018 Microbiological RNA Diagnostics

Technology one -step RT real-time PCR

Type of Analysis qualitative and quantitative

Target Sequence conservative region of 5’ UTR sequence

Specificity HCV genotype 1–7, 100 %

Sensitivity (LoD) reaches up to 23.518 IU/ml with probability of 95 % (on HCV NIBSC 02/264/01using manual extraction GeneProof PathogenFree RNA Isolation Kit)reaches up to 54.818 IU/ml with probability of 95 % (on HCV NIBSC 96/102 using automatic extraction MagCore NA Extractor)

Linear Range 1010 – 30 IU/ml with precision of ± 0.5 log

Reporting Units IU/µl

Conversion Factor 1 IU = 5.62 cp

Metrological Traceability HCV NIBSC 14/150

Extraction/Inhibition Control PCR inhibition and RNA extraction efficiency control (ISEXplus version)

Validated Specimen * plasma, serum

Storage -20 ± 5 °C

Validated Extraction Method croBEE NA16 Nucleic Acid Extraction SystemGeneProof PathogenFree RNA Isolation Kit

Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemDTlite Real-Time PCR SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR System

Required Detection Channels FAM, HEX

Quality Control in accordance with ISO 13485, each lot of GeneProof PCR Kit is tested against predetermined specifications to ensure consistent product quality

External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com

Certification1023  for in vitro Diagnostic Use

GeneProof Hepatitis C Virus (HCV) PCR Kit 1023

/ The PCR kit is designed for the Hepatitis C virus (HCV) RNA detection by the one-step RT real-time Polymerase Chain Reaction (PCR) method.

The HCV detection consists in amplification of a single-copy 5' UTR RNA sequence and in measurement of fluorescence increase. The HCV presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is included in the PCR kit, controlling the whole diagnostic process, i.e. RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into cDNA) and PCR amplification efficiency (PCR inhibition). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detections.

Product name Technology Cat. No.

25 reactions 50 reactions 100 reactions

GeneProof Hepatitis C Virus (HCV) PCR Kit one-step RT real-time PCR HCV/PLUS/025 HCV/PLUS/050 HCV/PLUS/100

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* Current overview is available at www.geneproof.com, or please request the current list at [email protected]

9PRODUCT CATALOGUE | 2018Microbiological RNA Diagnostics

www.geneproof.com

Technology one-step RT real-time PCR


Target Sequence LTR sequence and GaG gene

Specificity Human immunodeficiency virus type 1 (HIV-1), 100 %

Sensitivity (LoD) reaches up to 27.0788 IU/ml with the probability of 95 % (on HIV NIBSC using automatic extraction MagCore NA Extractor)

Linear Range 108 – 103 IU/ml with precision of ± 0.5 log

Dynamic Range 108 – 27.0788 IU/ml



Metrological Traceability AcroMetrix® HIV-1 Panel

Extraction/Inhibition Control PCR inhibition and RNA extraction efficiency control (ISEX version)



Validated Extraction Method croBEE NA16 Nucleic Acid Extraction SystemGeneProof PathogenFree RNA Isolation Kit

Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemDTlite Real-Time PCR SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System







GeneProof HIV type 1 (HIV-1) PCR Kit one-step RT real-time PCR HIV1/ISEX/025 HIV1/ISEX/050 HIV1/ISEX/100

GeneProof HIV type 1 (HIV-1) PCR Kit 1023

/ The PCR kit is designed for the HIV-1 RNA detection by the one-step RT real-time Polymerase Chain Reaction (PCR) method.

The HIV-1 detection consists in amplification of a specific region of the LTR sequence and a region of the GaG gene sequence and in measurement of fluorescence increase. Duplex targeting provides maximum sensitivity and specificity for all variants of the HIV-1virus from the M group (including groups N and O) and for the virus CRF variants. The HIV-1 presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is included in the PCR kit, controlling the whole diagnostic process, i.e. RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into cDNA) and PCR amplification efficiency (PCR inhibition). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detections.

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10 PRODUCT CATALOGUE | 2018 Microbiological RNA Diagnostics

GeneProof Enterovirus PCR Kit

/ The PCR kit is designed for the Enterovirus RNA detection by the one-step RT real-time Polymerase Chain Reaction (PCR) method.

The Enterovirus detection consists in amplification of a of 5’ UTR RNA sequence and in measurement of fluorescence increase. The Enterovirus presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is included in the PCR kit, controlling the whole diagnostic process, i.e. RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into cDNA) and PCR amplification efficiency (PCR inhibition). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detections.

IN DEVELOPMENT

We have been developing this product. We will inform you of the new product launch.

11PRODUCT CATALOGUE | 2018Microbiological DNA Diagnostics

www.geneproof.com

GeneProof Microbiological DNA Diagnostics Technology

ISIN ISEX

/ SAMPLE

positive sample contains microorganism DNA 

/ DNA ISOLATION

after the isolation the extracted sample DNA  is added into the Ready to Use MasterMix and the tube is inserted into the real-time device

/ PCR AMPLIFICATION

both pathogen DNA and Internal Standard DNA are amplified from the same primer pair  during the PCR

POSITIVE SAMPLE–   exponential fluorescence growth of the FAM fluorophore is 

evident if the target pathogen DNA is present in the sample

QUALITY CONTROL FOR THE DIAGNOSTIC PROCESS–   exponential growth of the HEX fluorophore fluorescence,

as a result of the IS amplification, controls the following:

1.  Inhibition and efficiency of the PCR amplification – ISIN version2.  DNA extraction quality, inhibition and efficiency of the PCR 

amplification – ISEX version

/ EVALUATION

/ SAMPLE

Internal Standard is added into the sample before the DNA isolation

/ DNA ISOLATION

after the isolation the extracted sample DNA  with the concurrently isolated Internal Standard DNA  are added into the Ready to Use MasterMix and the tube is inserted into the real-time device

/ PCR AMPLIFICATION

both pathogen DNA and Internal Standard DNA are amplified from the same primer pair  during the PCR

12 PRODUCT CATALOGUE | 2018 Microbiological DNA Diagnostics

Technology real-time PCR


Target Sequence DNA conservative sequence of open reading frame X (ORFx)

Specificity HBV genotype A-H, pre-core mutants HBV (HBeAg negative), 100 %

Sensitivity (LoD) reaches up to 36.9792 IU/ml with probability of 95 % (on HBV NIBSC 02/264/01 using manual extraction GeneProof PathogenFree DNA Isolation Kit)

Linear Range 1010 – 102.5 IU/ml with precision of ± 0.5 log

Dynamic Range 1010 – 36.9792 IU/ml



Metrological Traceability HBV NIBSC 10/264

Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control (ISEX version)



Validated Extraction Method croBEE NA16 Nucleic Acid Extraction SystemGeneProof PathogenFree DNA Isolation Kit

Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemDTlite Real-Time PCR SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System







GeneProof Hepatitis B Virus (HBV) PCR Kit real-time PCR HBV/ISEX/025 HBV/ISEX/050 HBV/ISEX/100

GeneProof Hepatitis B Virus (HBV) PCR Kit 1023

/ The PCR kit is designed for detection of Hepatitis B virus (HBV) by the real-time Polymerase Chain Reaction (PCR) method.

The HBV detection consists in amplification of a specific conservative DNA sequence of an open reading frame X (ORFx) and in measurement of fluorescence increase. The HBV presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is included in the PCR kit, controlling the possible inhibition of the PCR and the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil DNA glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

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www.geneproof.com



Target Sequence the specific conservative DNA sequence overlapping the boundary between the gene for the VP1 and VP2 proteins

Specificity BK virus, 100 %JC virus, 100 %

Sensitivity (LoD) for BKV reaches up to 180.687 IU/ml with the probability of 95 % (on BKV NIBSC 14/212 using manual extraction GeneProof PathogenFree DNA Isolation Kit)for JCV reaches up to 180.81 IU/ml with the probability of 95 % (on JCV NIBSC 14/114 using manual extraction GeneProof PathogenFree DNA Isolation Kit)

Linear Range 1010 – 102 cp/ml with precision of ± 0.5 log

Reporting Units cp/µl

Metrological Traceability BKV Molecular 'Q' Panel (Qnostics BKV)JCV Molecular 'Q' Panel (Qnostics JCV)

Extraction/Inhibition Control PCR inhibition control (ISIN version)PCR inhibition and DNA extraction efficiency control (ISEX version)

Validated Specimen * CSF, plasma, urine, whole blood



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 480LineGene 9600 / 9600 PlusRotor-Gene 3000 / QSLAN® Real-Time PCR System

Required Detection Channels FAM, HEX, Cy5



Certification  for in vitro Diagnostic Use

GeneProof BK/JC Virus (BK/JC) PCR Kit

/ The PCR kit is designed for BK/JC viruses detection and differentiation by the real-time Polymerase Chain Reaction (duplex PCR) method.

The BK/JC viruses detection and differentiation consists in amplification of a specific conservative DNA sequence overlapping the boundary between the gene for the VP1 and VP2 proteins and in measurement of fluorescence increase. The BK virus presence is indicated by the FAM fluorophore fluorescence growth and the JC virus presence is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil DNA glycosylase (UDG) eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.



GeneProof BK/JC Virus (BK/JC) PCR Kit real-time PCR BKJC/ISIN/025 BKJC/ISIN/050 BKJC/ISIN/100

GeneProof BK/JC Virus (BK/JC) PCR Kit real-time PCR BKJC/ISEX/025 BKJC/ISEX/050 BKJC/ISEX/100

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Specificity BK virus, 100 %

Sensitivity (LoD) reaches up to 180.687 IU/ml with the probability of 95 % (on BKV NIBSC 14/212 using manual extraction GeneProof PathogenFree DNA Isolation Kit)

Linear Range 1010 – 102 cp/ml with precision of ± 0.5 log


Metrological Traceability BKV Molecular 'Q' Panel (Qnostics BKV)


Validated Specimen * CSF, plasma, urine, whole blood



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR SystemStepOne™/StepOnePlus™ Real-Time PCR System







GeneProof BK Virus (BKV) PCR Kit real-time PCR BKV/ISIN/025 BKV/ISIN/050 BKV/ISIN/100

GeneProof BK Virus (BKV) PCR Kit real-time PCR BKV/ISEX/025 BKV/ISEX/050 BKV/ISEX/100

GeneProof BK Virus (BKV) PCR Kit

/ The PCR kit is designed for BK virus detection by the real-time Polymerase Chain Reaction (PCR) method.

The BK virus detection consists in amplification of the specific conservative DNA sequence overlapping the boundary between the gene for the VP1 and VP2 proteins and in measurement of fluorescence increase. The BK virus presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA glycosylase (UDG) eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

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Specificity JC virus, 100 %

Sensitivity (LoD) reaches up to 180.81 IU/ml with the probability of 95 % (on JCV NIBSC 14/114 using manual extraction GeneProof PathogenFree DNA Isolation Kit)



Metrological Traceability JCV Molecular 'Q' Panel (Qnostics JCV)


Validated Specimen * whole blood, plasma, urine, CSF



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System







GeneProof JC Virus (JCV) PCR Kit real-time PCR JCV/ISIN/025 JCV/ISIN/050 JCV/ISIN/100

GeneProof JC Virus (JCV) PCR Kit real-time PCR JCV/ISEX/025 JCV/ISEX/050 JCV/ISEX/100

GeneProof JC Virus (JCV) PCR Kit

/ The PCR kit is designed for JC virus detection by the real-time Polymerase Chain Reaction (PCR) method.

The JC virus detection consists in amplification of a specific conservative DNA sequence overlapping the boundary between the gene for the VP1 and VP2 proteins and in measurement of fluorescence increase. The JC virus presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA glycosylase (UDG) eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

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Target Sequence specific conservative DNA sequence of a single copy gene encoding the 4 IE antigen

Specificity Human Cytomegalovirus (CMV), 100 %

Sensitivity (LoD) reaches up to 122.594 IU/ml with the probability of 95 % (on CMV NIBSC 09/162 using manual extraction GeneProof PathogenFree DNA Isolation Kit)reaches up to 165.237 IU/ml with the probability of 95 % (on CMV NIBSC 09/162 using automatic extraction croBEE NA16 Nucleic Acid Extraction System)

Linear Range 1010 – 102.5 cp/ml with precision of ± 0.5 log


Conversion Factor 1 IU = 1 cp

Metrological Traceability CMV NIBSC 09/162


Validated Specimen * BAL, CSF, plasma, saliva, sperm, swab, urine, whole blood



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System







GeneProof Cytomegalovirus (CMV) PCR Kit real-time PCR CMV/ISIN/025 CMV/ISIN/050 CMV/ISIN/100

GeneProof Cytomegalovirus (CMV) PCR Kit real-time PCR CMV/ISEX/025 CMV/ISEX/050 CMV/ISEX/100

GeneProof Cytomegalovirus (CMV) PCR Kit 1023

/ The PCR kit is designed for detection of human Cytomegalovirus by the real-time Polymerase Chain Reaction (PCR) method.

The CMV detection consists in amplification of a specific conservative DNA sequence of a single copy gene encoding the 4 IE antigen and in measurement of fluorescence increase. The CMV presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing nonspecific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

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www.geneproof.com



Target Sequence DNA sequence of the single copy gene encoding the nuclear antigen 1 (EBNA1)

Specificity Epstein-Barr virus, 100 %

Sensitivity (LoD) reaches up to 196.088 IU/ml with the probability of 95 % (on NIBSC EBV 09/260 using manual extraction GeneProof PathogenFree DNA Isolation Kit)

Linear Range 1010 – 102.5 IU/ml with precision of ± 0.5 log



Metrological Traceability NIBSC EBV 09/260


Validated Specimen * CSF, plasma, whole blood










GeneProof Epstein-Barr Virus (EBV) PCR Kit real-time PCR EBV/ISIN/025 EBV/ISIN/050 EBV/ISIN/100

GeneProof Epstein-Barr Virus (EBV) PCR Kit real-time PCR EBV/ISEX/025 EBV/ISEX/050 EBV/ISEX/100

GeneProof Epstein-Barr Virus (EBV) PCR Kit

/ The PCR kit is designed for detection of Epstein-Barr virus (EBV) by the real-time Polymerase Chain Reaction (PCR) method.

The EBV detection consists in amplification of a specific conservative DNA sequence of the single copy gene encoding the nuclear antigen 1 (EBNA1) and in measurement of fluorescence increase. The EBV presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

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Target Sequence specific conservative DNA sequence of a single-copy gene encoding glycoprotein B (gB)

Specificity Herpes simplex virus type 1 (HSV-1), 100 %

Sensitivity (LoD) reaches up to 122.124 cp/ml with the probability of 95 % (on AcroMetrix™ HSV-1 Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)

Linear Range 1010 – 102.5 cp/ml with precision of ± 0.5 log


Metrological Traceability AcroMetrix™ HSV-1 Plasma Panel (AcroMetrix HSV-1)





Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System







GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit real-time PCR HSV1/ISIN/025 HSV1/ISIN/050 HSV1/ISIN/100

GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit real-time PCR HSV1/ISEX/025 HSV1/ISEX/050 HSV1/ISEX/100

GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit

/ The PCR Kit is designed for detection of Herpes simplex virus type 1 (HSV-1) by the real-time Polymerase Chain Reaction (PCR) method.

The HSV-1 detection consists in amplification of a specific conservative DNA sequence of a single-copy gene encoding the glycoprotein B (gB) and in measurement of fluorescence increase. The HSV-1 presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

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www.geneproof.com



Target Sequence specific conservative DNA sequence of a single-copy gene encoding the glycoprotein B (gB)

Specificity Herpes simplex virus type 2 (HSV-2), 100 %

Sensitivity (LoD) reaches up to 197.215 cp/ml with the probability of 95 % (on AcroMetrix™ HSV-2 Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)

Linear Range 1010 – 102.5 cp/ml with precision of ± 0.5 log


Metrological Traceability AcroMetrix™ HSV-2 Plasma Panel (AcroMetrix HSV-2)





Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System







GeneProof Herpes Simplex Virus 2 (HSV-2) PCR Kit real-time PCR HSV2/ISIN/025 HSV2/ISIN/050 HSV2/ISIN/100

GeneProof Herpes Simplex Virus 2 (HSV-2) PCR Kit real-time PCR HSV2/ISEX/025 HSV2/ISEX/050 HSV2/ISEX/100

GeneProof Herpes Simplex Virus 2 (HSV-2) PCR Kit

/ The PCR kit is designed for detection of Herpes simplex virus type 2 (HSV-2) by the real-time Polymerase Chain Reaction (PCR) method.

The HSV-2 detection consists in amplification of a specific conservative DNA sequence of a single-copy gene encoding the glycoprotein B (gB) and in measurements of fluorescence increase. The HSV-2 presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

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Target Sequence specific conservative DNA sequence of a single-copy gene encoding glycoprotein B (gB)

Specificity Herpes simplex virus type 1 (HSV-1), 100 %Herpes simplex virus type 2 (HSV-2), 100 %

Sensitivity (LoD) for HSV-1 reaches up to 122.124 cp/ml with the probability of 95 % (on AcroMetrix™ HSV-1 Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)for HSV-2 reaches up to 194.49 cp/ml with the probability of 95 % (on AcroMetrix™ HSV-2 Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)

Linear Range for HSV-1: 1010 – 102.5 cp/ml with precision of ± 0.5 logfor HSV-2: 1010 – 102.5 cp/ml with precision of ± 0.5 log


Metrological Traceability AcroMetrix™ HSV-1 Plasma Panel (AcroMetrix HSV-1)AcroMetrix™ HSV-2 Plasma Panel (AcroMetrix HSV-2)










GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit

/ The PCR kit is designed for detection and differentiation of both types of Herpes simplex viruses (HSV-1 and HSV-2) by the real-time Polymerase Chain Reaction (duplex PCR) method.

The HSV detection and differentiation consists in amplification of a specific conservative DNA sequence of a single-copy gene encoding the glycoprotein B (gB) and in measurement of fluorescence increase. The HSV-1 presence is indicated by the FAM fluorophore fluorescence growth and the HSV-2 presence is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil DNA glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.



GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit real-time PCR HSV/ISIN/025 HSV/ISIN/050 HSV/ISIN/100

GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit real-time PCR HSV/ISEX/025 HSV/ISEX/050 HSV/ISEX/100

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Target Sequence a specific conservative DNA sequence of the single-copy gene ORF62

Specificity Varicella-zoster virus (VZV), 100 %

Sensitivity (LoD) reaches up to 113.05 cp/ml with the probability of 95 % (on AcroMetrix™ VZV High Plasma Control using manual extraction GeneProof PathogenFree DNA Isolation Kit)



Metrological Traceability AcroMetrix™ VZV High Plasma Control (cat. n. 954514)


Validated Specimen * whole blood, plasma, serum, CSF








GeneProof Varicella-Zoster Virus (VZV) PCR Kit

/ The PCR kit is designed for detection of Varicella-zoster virus (VZV) by the real-time Polymerase Chain Reaction (PCR) method.

The VZV detection consists in amplification of a specific conservative DNA sequence of the single copy gene ORF62 and in measurement of fluorescence increase. The VZV presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.



GeneProof Varicella-Zoster Virus (VZV) PCR Kit real-time PCR VZV/ISIN/025 VZV/ISIN/050 VZV/ISIN/100

GeneProof Varicella-Zoster Virus (VZV) PCR Kit real-time PCR VZV/ISEX/025 VZV/ISEX/050 VZV/ISEX/100

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/ The PCR kit is designed for detection and differenciation of the Human herpervirus 6A, Human herpesvirus 6B and Human herpesvirus 7 (HHV-6A, HHV-6B a HHV-7) by the real-time Polymerase Chain Reaction (PCR) method.

The HHV-6A and HHV-6B detection and differentiation consists in amplification of the specific DNA sequence of U94 gene coding the pupative integrase Rep68 and in measurement of fluorescence increase. The HHV-6A/B presence is indicated by the FAM fluorophore fluorescence growth. The HHV-6B presence is indicated by the Texas Red fluorophore fluorescence growth. The HHV-7 detection consists in amplification of the specific DNA sequence of U57 gene coding the major capsid protein and in measurement of fluorescence increase. The HHV-7 presence is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

GeneProof Human Herpes Virus 6/7 (HHV-6/7) PCR Kit

NEW PRODUCT



Target Sequence HHV-6A/B – U94 geneHHV-7 – U57 gene

Specificity Human herpesvirus 6A/B (HHV-6A/B)Human herpesvirus 7 (HHV-7)

Sensitivity (LoD) reaches up to 5×102 cp/ml

Linear Range 106 – 5×102 cp/ml

Reporting Units cp/ml

Metrological Traceability Qnostics Panel – HHV6 Analytical Panel 02 (REF: HHV6AQP02-B)only for HHV6A


Validated Specimen * whole blood, serum, plasma, CSF, BAL



Validated Instruments * croBEE Real-Time PCR System

Required Detection Channels FAM, HEX, Texas Red, Cy5


External Quality Assessment regularly tested by QCMD External Quality Assessment Panels – results at www.geneproof.com




GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit real-time PCR HHV/ISIN/025 HHV/ISIN/050 HHV/ISIN/100

GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit real-time PCR HHV/ISEX/025 HHV/ISEX/050 HHV/ISEX/100

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GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit real-time PCR HHV8/ISIN/025 HHV8/ISIN/050 HHV8/ISIN/100

GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit real-time PCR HHV8/ISEX/025 HHV8/ISEX/050 HHV8/ISEX/100

GeneProof Human Herpes Virus 8 (HHV-8) PCR Kit

/ The PCR kit is designed for Human herpesvirus 8 (HHV-8) detection by the real-time Polymerase Chain Reaction (PCR) method.

The HHV-8 detection consists in amplification of the specific conservative DNA sequence of the ORF26 gene coding the minor capsid protein (mCP) and ORF73 gene coding the latency-associated nuclear antigen (LANA) and in measurement of fluorencence increase. The HHV-8 presence is indicated by FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

NEW PRODUCT



Target Sequence ORF26 and ORF73 genes

Specificity Human herpesvirus 8

Sensitivity (LoD) reaches up to 0.7 cp/μl

Linear Range 107 – 100.5 cp/µl



Validated Specimen * serum, plasma, whole blood



Validated Instruments * croBEE Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System




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GeneProof Parvovirus B19 PCR Kit

/ The PCR kit is designed for Parvovirus B19 detection by the real-time Polymerase Chain Reaction (PCR) method.

The Parvovirus B19 detection consists in amplification of a unique region of the structural ORF coding minor capsid protein VP1 and in measurement of fluorescence increase. The Parvovirus B19 presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

NEW PRODUCT



Target Sequence VP1

Specificity Parvovirus B19


Validated Specimen * whole blood, plasma



Validated Instruments * CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System







GeneProof Parvovirus B19 PCR Kit real-time PCR B19/ISIN/025 B19/ISIN/050 B19/ISIN/100

GeneProof Parvovirus B19 PCR Kit real-time PCR B19/ISEX/025 B19/ISEX/050 B19/ISEX/100

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Target Sequence highly conservative DNA sequence of E2B gene

Specificity Adenovirus, 100 %

Sensitivity (LoD) reaches up to 81.41 cp/ml with the probability of 95 % (on AcroMetrix™ Adenovirus Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)

Linear Range 1010 – 102.5 cp/ml


Metrological Traceability AcroMetrix™ Adenovirus Plasma Panel


Validated Specimen * aspirate, plasma, stool, swab, urine, whole blood


Validated Extraction Method croBEE NA16 Nucleic Acid Extraction SystemGeneProof PathogenFree DNA Isolation KitQIAamp DNA Stool Mini Kit

Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 480LineGene 9600 / 9600 PlusQuantStudio 3 Real-Time PCR SystemRotor-Gene 3000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System





GeneProof Adenovirus PCR Kit

/ The PCR kit is designed for Adenovirus detection by the real-time Polymerase Chain Reaction (PCR) method.

The Adenovirus detection consists in amplification of highly conservative DNA sequence of E2B gene and in measurement of fluorescence increase. The Adenovirus presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

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GeneProof Adenovirus PCR Kit real-time PCR ADV/ISIN/025 ADV/ISIN/050 ADV/ISIN/100

GeneProof Adenovirus PCR Kit real-time PCR ADV/ISEX/025 ADV/ISEX/050 ADV/ISEX/100

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Type of Analysis qualitative

Target Sequence ITS2/28S rDNA region

Specificity Aspergillus spp. (A. fumigatus, A. flavus, A. niger), 100 %Aspergillus terreus, 100 %

Sensitivity (LoD) reaches up to 48.838 ge/μl with the probability of 95 % (on Amplirun® Aspergillus fumigatus DNA control, Vircell)

Extraction / Inhibition Control PCR inhibition control (ISIN version)PCR inhibition and DNA extraction efficiency control (ISEX version)

Validated Specimen * BAL, CSF, plasma, serum, sputum, whole blood


Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction SystemGeneProof PathogenFree DNA Isolation Kit






GeneProof Aspergillus PCR Kit

/ The PCR kit is designed for the detection of the clinically significant Aspergillus species (A. fumigatus, A. flavus, A. niger, A. terreus) by the real-time Polymerase Chain Reaction (PCR) method.

The Aspergillus spp. detection consists in amplification of a specific ribosomal DNA sequence and in measurement of fluorescence increase. The Aspergillus spp. presence is indicated by the FAM fluorophore fluorescence growth and the presence of Aspergillus terreus is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.

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GeneProof Aspergillus Sample Pretreatment Set

Product name TechnologyCat. No.

10 preps. 25 reactions 50 reactions 100 reactions

GeneProof Aspergillus PCR Kit real-time PCR – ASP/ISIN/025 ASP/ISIN/050 ASP/ISIN/100

GeneProof Aspergillus PCR Kit real-time PCR – ASP/ISEX/025 ASP/ISEX/050 ASP/ISEX/100

GeneProof Aspergillus Sample Pretreatment Set Pretreatment Set ASP/010 – – –

/ The Sample Pretreatment Set is designed for use in diagnostic laboratories dealing with routine PCR diagnostics of clinically significant representatives of the Aspergillus species.

The sample pretreatment step allows disintegration of the fungal cell wall, which subsequently increases the efficiency of DNA extraction. The set is designed for fungal DNA extraction from many types of clinical materials (blood, plasma, serum, CSF, sputum and BAL).

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GeneProof Sample Pretreatment Technology

/ CLINICAL MATERIAL PREPARATION

the material is added to a tube containing specially modified beads

/ SAMPLE CONCENTRATION

the sample is concentrated by centrifugation and subsequent partial removal of the supernatant

/ SAMPLE LYSIS

DNA is released from cells by combining chemical lysis in the presence of lysis buffers and mechanical vortexing with the beads at 70 °C

/ DNA ISOLATION

the prepared lysate is further processed according to the standard GeneProof Pathogen Free Isolation Kit protocol

70 °C


GeneProof Borrelia burgdorferi PCR Kit

/ The PCR kit is designed for detection of clinically important Borrelia species from the Borrelia burgdorferi sensu lato group causing Lyme disease and for detection of Borrelia miyamotoi causing tick-borne relapsing fever, by the real-time Polymerase Chain Reaction (PCR) method.

The detection consists in amplification of the gene sequence encoding 16S rRNA and in measurement of fluorescence increase. The B. burgdorferi presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.



Target Sequence the gene sequence encoding 16S rRNA

Specificity B. burgdorferi sensu stricto, B. garinii, B. afzelii, B. andersonii, B. bissettii, B. valaisiana, B. lusitaniae, B. japonica, B. tanukii, B. turdi, B. sinica, B. miyamotoi, B. mayonii, B. spielmanii, B. bavariensis, B. kurtenbachii, 100 %

Sensitivity (LoD) reaches up to 0.568 cp/μl with the probability of 95 % (on Amplirun® Borrelia burgdorferi DNA control, Vircell)


Validated Specimen * CSF, plasma, serum, tick, urine, whole blood



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™/ Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System







GeneProof Borrelia burgdorferi PCR Kit real-time PCR BB/ISIN/025 BB/ISIN/050 BB/ISIN/100

GeneProof Borrelia burgdorferi PCR Kit real-time PCR BB/ISEX/025 BB/ISEX/050 BB/ISEX/100

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Target Sequence a multi-copy sequence of the gene encoding 16S rRNA and porA pseudogene specific for N. gonorrhoeae

Specificity N. gonorrhoeae, including mutants in porA pseudogene, 100 %

Sensitivity (LoD) reaches up to 0.109 cp/μl with the probability 95 % (on Amplirun® Neisseria gonorrhoeae DNA control, Vircell)


Validated Specimen * sperm, swab, urine



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System







GeneProof Neisseria gonorrhoeae PCR Kit real-time PCR NG/ISIN/025 NG/ISIN/050 NG/ISIN/100

GeneProof Neisseria gonorrhoeae PCR Kit real-time PCR NG/ISEX/025 NG/ISEX/050 NG/ISEX/100

GeneProof Neisseria gonorrhoeae PCR Kit

/ The PCR kit is designed for Neisseria gonorrhoeae detection by the real-time Polymerase Chain Reaction (PCR) method.

The N. gonorrhoeae detection consists in amplification of a multi-copy sequence of the gene encoding 16S rRNA and porA pseudogene specific for N. gonorrhoeae and in measurement of fluorescence increase. The N. gonorrhoeae presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.

The kit can sensitively detect porA mutants of N. gonorrhoeae that may go undetected by other kits.

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Target Sequence the cryptic plasmid multi-copy sequence and the gene encoding 16S rRNA scpecific for C. trachomatis

Specificity C. trachomatis, including mutations with deletions in cryptic plasmid (including Swedish variant), 100 %

Sensitivity (LoD) reaches up to 0.075 cp/μl with the probability of 95 % (on Amplirun® Chlamydia trachomatis DNA control, Vircell)


Validated Specimen * sperm, swab, urine



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemDTlite Real-Time PCR SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System







GeneProof Chlamydia trachomatis PCR Kit real-time PCR CHT/ISIN/025 CHT/ISIN/050 CHT/ISIN/100

GeneProof Chlamydia trachomatis PCR Kit real-time PCR CHT/ISEX/025 CHT/ISEX/050 CHT/ISEX/100

GeneProof Chlamydia trachomatis PCR Kit 1023

/ The PCR kit is designed for Chlamydia trachomatis detection by the real-time Polymerase Chain Reaction (PCR) method.

The C. trachomatis detection consists in amplification of both the cryptic plasmid multi copy sequence and the gene encoding 16S rRNA specific for C. trachomatis and in measurement of fluorescence increase. Detection of multi copy sequence of the cryptic plasmid enables very high sensitivity of Chlamydia detection (including the Swedish variant) and the chromosomal gene detection at the same time enables high specificity and makes detection of plasmidless strains possible. The C. trachomatis presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.

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Target Sequence E1/E2 gene

Specificity high-risk HPV:16, 18, 26, 30, 31, 33, 34, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68, 69, 70, 73, 82, 97typization: HPV 16, 18, 45

Sensitivity (LoD) reaches up to 745 IU/ml for HPV 16reaches up to 1561 IU/ml for HPV 18

Extraction / Inhibition Control PCR inhibition and DNA extraction efficiency control (ISEX version)

Validated Specimen * swab (cervical, penis, vaginal)



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemSLAN® Real-Time PCR SystemVERSANT® kPCR Molecular System

Required Detection Channels FAM, HEX, Cy5, Texas Red, Cy5.5






GeneProof Human Papillomavirus (HPV) PCR Kit real-time PCR HPVS/ISEX/025 HPVS/ISEX/050 HPVS/ISEX/100

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GeneProof Human Papilloma Virus (HPV) PCR Kit

/ The PCR kit is designed for the detection of 24 high-risk types of Human Papillomavirus (HPV) and typization of HPV 16, 18, 45 by the real-time Polymerase Chain Reaction (PCR) method.

The HPV detection consists in amplification of specific conservative DNA sequence in the area of E1/E2 genes and in measurement of fluorescence increase. The kit enables detection of following high-risk types HPV: 16, 18, 26, 30, 31, 33, 34, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68, 69, 70, 73, 82, 97. The high-risk types HPV presence is indicated by the FAM fluorofore fluorescence growth. The kit enables simoultaneously type HPV 16, 18 a 45. The HPV16 presence is indicated in the Cy5 fluorofore fluorescence channel, HPV 18 in the Texas Red fluorescence channel and HPV 45 in the Cy5.5 fluorescence channel. For the DNA isolation quality control and possible PCR inhibition control there are primers and probe for GAPDH gene amplification present in the reaction mix. Amplification of GAPDH gene is indicated in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.

NEW PRODUCT

This PCR kit can be used as a screening test in the cervical cancer screening program.



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GeneProof Human Papillomavirus Technology

/ SAMPLE

positive sample contains  viral DNA  DNA for human GAPDH

/ DNA ISOLATION

after the isolation the extracted sample DNA is added into Ready to Use MasterMix and the tube is inserted into the real-time device

/ PCR AMPLIFICATION

during PCR, viral DNA is amplified from one primer pair  and control human DNA amplified from the other primer pair 

HPV GAPDH

POSITIVE SAMPLE–   exponential fluorescence growth of the FAM, Cy5, 

Texas Red or Cy5.5 fluorophore is evident if the target viral DNA is present in the sample

/ EVALUATION

QUALITY CONTROL FOR THE COMPLETE DIAGNOSTIC PROCESS–   exponential growth of the HEX fluorophore fluorescence, 

as a result of the control human DNA amplification, controls the following:

1.  sample quality – sample DNA (and therefore also the viral RNA) was not degraded

2.  DNA extraction quality – sample DNA was extracted with sufficient efficiency

3.  PCR amplification quality – sample DNA was efficiently amplified, no PCR inhibition




Target Sequence a multicopy sequence of the gene encoding the 16S rRNA (M. genitalium) and the housekeeping gap gene for glyceraldehyde-3-phosphate dehydrogenase (M. hominis)

Specificity M. genitalium, 100 %M. hominis, 100 %

Sensitivity (LoD) reaches up to 1.256 cp/μl with the probability 95 % for M. genitaliumreaches up to 1.196 cp/μl with the probability 95 % for M. hominis


Validated Specimen * swab, urine



Validated Instruments * 3-channel detectioncroBEE Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX96™ / Dx Real-Time PCR Detection SystemLineGene 9600 / 9600 PlusRotor-Gene 3000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System

2-channel detectionCFX Connect™ Real-Time PCR SystemQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 6000

Required Detection Channels FAM, HEX, Cy5 FAM, HEXif a 2-channel system is used, only the presence of M. genitalium is detected in the FAM channel




GeneProof Mycoplasma genitalium/hominis PCR Kit

/ The PCR kit is designed for Mycoplasma genitalium and Mycoplasma hominis detection and differentiation by the real-time Polymerase Chain Reaction (PCR) method.

The M. genitalium and M. hominis detection and differentiation consist in amplification of a multicopy sequence of the gene encoding the 16S rRNA (M. genitalium) and the housekeeping gap gene for glyceraldehyde-3-phosphate dehydrogenase (M. hominis) and in measurement of fluorescence increase. The M. genitalium presence is indicated by the FAM fluorophore fluorescence growth and the M. hominis presence is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.



GeneProof Mycoplasma genitalium/hominis PCR Kit real-time PCR MGH/ISIN/025 MGH/ISIN/050 MGH/ISIN/100

GeneProof Mycoplasma genitalium/hominis PCR Kit real-time PCR MGH/ISEX/025 MGH/ISEX/050 MGH/ISEX/100

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Target Sequence UreD gene

Specificity U. parvum, 100 %U. urealyticum, 100 %

Sensitivity (LoD) reaches up to 0.687 cp/μl with the probability 95 % (on Amplirun® Ureaplasma urealyticum DNA control, Vircell)


Validated Specimen * swab, urine



Validated Instruments * 3-channel detectioncroBEE Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 480LineGene 9600 / 9600 PlusRotor-Gene 3000 / QSLAN® Real-Time PCR System

2-channel detectionCFX Connect™ Real-Time PCR SystemQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 6000StepOne™ / StepOnePlus™ Real-Time PCR System

Required Detection Channels FAM, HEX, Cy5 FAM, HEXif a 2-channel system is used, only the presence of Ureaplasma spp. without any further differentiation is detected in the FAM channel

Quality Control ín accordance with ISO 13485, each lot of GeneProof PCR Kit is tested against predetermined specifications to ensure consistent product quality



GeneProof Ureaplasma PCR Kit

/ The PCR kit is designed for Ureaplasma parvum and Ureaplasma urealyticum detection and differentiation by the real-time Polymerase Chain Reaction (PCR) method.

The U. parvum and U. urealyticum detection and differentiation consist in amplification of a conservative sequence of UreD gene and in measurement of fluorescence increase. The U. parvum presence is indicated by the FAM fluorophore fluorescence growth only. The U. urealyticum presence is indicated by the fluorescence growth in both FAM and Cy5 channels. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.



GeneProof Ureaplasma PCR Kit real-time PCR UUP/ISIN/025 UUP/ISIN/050 UUP/ISIN/100

GeneProof Ureaplasma PCR Kit real-time PCR UUP/ISEX/025 UUP/ISEX/050 UUP/ISEX/100

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Target Sequence the multi-copy insertion sequences IS1002 (specific for both Bordetella pertussis/parapertussis) and IS1001 (specific only for B. parapertussis)

Specificity B. pertussis, 100 %B. parapertussis, 100 %

Sensitivity (LoD) reaches up to 0.212 cp/μl with the probability 95 % (on Amplirun® Bordetella pertussis DNA control, Vircell)


Validated Specimen * aspirate, sputum, swab



Validated Instruments * croBEE Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 480LineGene 9600 / 9600 PlusRotor-Gene 3000 / QSLAN® Real-Time PCR System





GeneProof Bordetella pertussis/parapertussis PCR Kit

/ The PCR kit is designed for Bordetella pertussis and Bordetella parapertussis detection and differentiation by the real-time Polymerase Chain Reaction (PCR) method.

The B. pertussis and B. parapertussis detection and differentiation consist in amplification of the multi-copy insertion sequences IS1002 (specific for both Bordetella pertussis/parapertussis) and IS1001 (specific only for B. parapertussis) and in measurement of fluorescence increase. GeneProof Bordetella pertussis/parapertussis PCR Kit is one of the few kits in the market that does not provide false positive results for Bordetella holmesii. The B. pertussis presence is indicated by the FAM fluorophore fluorescence growth only. The B. parapertussis presence is indicated by the fluorescence growth in both FAM and Cy5 channels. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil DNA glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.



GeneProof Bordetella pertussis/parapertussis PCR Kit real-time PCR BP/ISIN/025 BP/ISIN/050 BP/ISIN/100

GeneProof Bordetella pertussis/parapertussis PCR Kit real-time PCR BP/ISEX/025 BP/ISEX/050 BP/ISEX/100

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Target Sequence specific conservative DNA sequence of a single-copy ompA gene

Specificity C. pneumoniae, 100 %

Sensitivity (LoD) reaches up to 0.88 cp/μl with the probability 95 %


Validated Specimen * BAL, sputum, swab



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System





/ The PCR kit is designed for Chlamydia pneumoniae detection by the real-time Polymerase Chain Reaction (PCR) method.

The C. pneumoniae detection consists in amplification of a specific conservative DNA sequence of a single-copy ompA gene and in measurement of fluorescence increase. The C. pneumoniae presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.

GeneProof Chlamydia pneumoniae PCR Kit 1023



GeneProof Chlamydia pneumoniae PCR Kit real-time PCR CHP/ISIN/025 CHP/ISIN/050 CHP/ISIN/100

GeneProof Chlamydia pneumoniae PCR Kit real-time PCR CHP/ISEX/025 CHP/ISEX/050 CHP/ISEX/100

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Target Sequence the gene encoding 16S rRNA specific for L. pneumophila

Specificity L. pneumophila, 100 %

Sensitivity (LoD) reaches up to 0.578 cp/μl with the probability 95 % (on Amplirun® Legionella pneumophila DNA control, Vircell)





Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System





GeneProof Legionella pneumophila PCR Kit

/ The PCR kit is designed for Legionella pneumophila detection by the real-time Polymerase Chain Reaction (PCR) method.

The L. pneumophila detection consists in amplification of the gene encoding 16S rRNA specific for L. pneumophila and in measurement of fluorescence increase. The L. pneumophila presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR reaction (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.



GeneProof Legionella pneumophila PCR Kit real-time PCR LP/ISIN/025 LP/ISIN/050 LP/ISIN/100

GeneProof Legionella pneumophila PCR Kit real-time PCR LP/ISEX/025 LP/ISEX/050 LP/ISEX/100

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Target Sequence specific multi-copy insertion sequence IS6110

Specificity Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae, M. canetti and vaccine strain BCG), 100 %

Sensitivity (LoD) reaches up to 0.191 cp/μl with the probability 95 % (on Amplirun® Mycobacterium tuberculosis DNA control, Vircell)


Validated Specimen * BAL, CSF, sputum, stool, swab, urine



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System





GeneProof Mycobacterium tuberculosis PCR Kit

/ The PCR kit is designed for Mycobacterium tuberculosis detection by the real-time Polymerase Chain Reaction (PCR) method.

The M. tuberculosis detection consists in amplification of a specific multi-copy insertion sequence IS6110 and in measurement of fluorescence increase. The kit specifically detects strains of the Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae and M. canettii) and also vaccination strain BCG. The M. tuberculosis presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.



GeneProof Mycobacterium tuberculosis PCR Kit real-time PCR MT/ISIN/025 MT/ISIN/050 MT/ISIN/100

GeneProof Mycobacterium tuberculosis PCR Kit real-time PCR MT/ISEX/025 MT/ISEX/050 MT/ISEX/100

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Target Sequence the M181 gene sequence encoding the CARDS toxin

Specificity M. pneumoniae, 100 %

Sensitivity (LoD) reaches up to 0.46 cp/μl with the probability of 95 %





Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000 / QSLAN® Real-Time PCR System





GeneProof Mycoplasma pneumoniae PCR Kit

/ The PCR kit is designed for Mycoplasma pneumoniae detection by the real-time Polymerase Chain Reaction (PCR) method.

The M. pneumoniae detection consists in amplification of the DNA sequence of the M181 gene encoding the CARDS toxin and in measurement of fluorescence increase. The M. pneumoniae presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.



GeneProof Mycoplasma pneumoniae PCR Kit real-time PCR MP/ISIN/025 MP/ISIN/050 MP/ISIN/100

GeneProof Mycoplasma pneumoniae PCR Kit real-time PCR MP/ISEX/025 MP/ISEX/050 MP/ISEX/100

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Target Sequence specific conservative DNA sequence in the area of the vanA and vanB genes

Specificity vanA, vanB genes (e. g. Enterococcus faecalis, Enterococcus faecium, Enterococcus gallinarium, etc.), 100 %

Sensitivity (LoD) for vanA reaches up to 1.398 cp/μl with the probability of 95 %for vanB reaches up to 1.026 cp/μl with the probability of 95 %


Validated Specimen * sputum, stool, urine








GeneProof VRE PCR Kit

/ The PCR kit is designed for the detection of Vancomycin-Resistant Enterococci (VRE), e. g. Enterococcus faecalis and Enterococcus faecium, by the real-time Polymerase Chain Reaction (PCR) method.

The VRE detection consists in amplification of a specific conservative DNA sequence in the area of the vanA and vanB genes and in measurement of fluorescence increase. The vanA gene presence is indicated by the FAM fluorophore fluorescence growth and the vanB gene presence is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.



GeneProof VRE PCR Kit real-time PCR VRE/ISIN/025 VRE/ISIN/050 VRE/ISIN/100

GeneProof VRE PCR Kit real-time PCR VRE/ISEX/025 VRE/ISEX/050 VRE/ISEX/100

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Target Sequence blaSHV and blaCTX-M genes

Specificity SHV, 100 %CTX-M, 100 %

Sensitivity (LoD) for blaSHV reaches up to 0.365 cp/μl with the probability 95 %for blaCTX-M reaches up to 1.281 cp/μl with the probability 95 %


Validated Specimen * aspirate, BAL



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7500 Real-Time PCR SystemCFX96™ / Dx Real-Time PCR Detection SystemLineGene 9600 / 9600 PlusRotor-Gene 3000 / QSLAN® Real-Time PCR System





GeneProof ESBL PCR Kit

/ The PCR kit is designed for the detection of the detection of the blaSHV and blaCTX-M genes determining the ESBL (Extended-Spectrum Beta-Lactamases) genotype by the real-time Polymerase Chain Reaction (PCR) method.

The SHV ESBL detection consists in amplification of the blaSHV gene, discrimination of the individual mutations resulting in the ESBL genotype and in measurement of fluorescence increase in the FAM and Cy5 fluorophore fluorescence channels. The CTX-M ESBL detection consists in amplification of the blaCTX-M gene and the presence is indicated by the FAM fluorophore fluorescence growth. The kit enables the identification of all five known clusters CTX-M-1, CTX-M-2, CTX-M-8, CTX-M-9 a CTX-M-25. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.



GeneProof ESBL PCR Kit real-time PCR ESBL/ISIN/025 ESBL/ISIN/050 ESBL/ISIN/100

GeneProof ESBL PCR Kit real-time PCR ESBL/ISEX/025 ESBL/ISEX/050 ESBL/ISEX/100

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www.geneproof.com



Target Sequence nuc gene specific for Staphylococcus aureusSCCmec/orfX junction regionresistance gene mecA/mecC

Specificity Methicillin-resistant Staphylococcus aureus (MRSA)

Sensitivity (LoD) reaches up to 2.81 ge/ml with the probability of 95 % (on NCTC strain 13142)


Validated Specimen * aspirate, sputum, swab, urine



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX96™ / Dx Real-Time PCR Detection SystemLineGene 9600 / 9600 PlusRotor-Gene 3000 / Q

Required Detection Channels FAM, HEX, Cy5, Texas Red




GeneProof MRSA PCR Kit

/ The PCR kit is designed for methicillin-resistant Staphylococcus aureus detection by the real-time Polymerase Chain Reaction (PCR) method.

The MRSA detection consists in amplification of three specific loci (the nuc gene which is specific for Staphylococcus aureus, the SCCmec/orfX junction region and the resistance genes mecA/mecC) and in measurement of fluorescence increase. The nuc gene presence is indicated by the Texas Red fluorophore fluorescence growth. The SCCmec/orfX junction presence is indicated by the FAM fluorophore fluorescence growth. The resistance gene mecA/mecC presence is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.

NEW PRODUCT



GeneProof MRSA PCR Kit real-time PCR MRSA/ISIN/025 MRSA/ISIN/050 MRSA/ISIN/100

GeneProof MRSA PCR Kit real-time PCR MRSA/ISEX/025 MRSA/ISEX/050 MRSA/ISEX/100

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GeneProof CT/NG/MG Multiplex PCR Kit 1023

/ The PCR kit is designed for Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium detection an differentiation by the real-time Polymerase Chain Reaction (multiplex PCR) method.

The pathogens detection and differentiation consist in amplification of the specific DNA sequences and in measurement of fluorescence increase. The C. trachomatis detection consists in amplification of both the cryptic plasmid multi-copy sequence and the gene encoding 16S rRNA and the presence is indicated by the FAM fluorophore fluorescence growth. The N. gonorrhoeae detection consists in amplification of multi-copy sequence of the gene encoding 16S rRNA and porA pseudogene and the presence is indicated by the Cy5 fluorophore fluorescence growth. The M. genitalium detection consists in amplification of a multicopy sequence of the gene encoding the 16S rRNA and the presence is indicated by the TexasRed fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.

IN DEVELOPMENT

We have been developing this product. We will inform you of the new product launch.

45PRODUCT CATALOGUE | 2018

www.geneproof.com

GeneProof Genetic Diagnostics Technology

/ SAMPLE

sample contains  wild-type allele mutant allele

/ ISOLATION

the extracted sample DNA is added into the Ready to Use MasterMix and the tube is inserted into the real-time device

/ PCR AMPLIFICATION

individual alleles are amplified in the course of PCR

WT MUT

WILD-TYPE HETEROZYGOTE MUTANT

HETEROZYGOTE–   both alleles are detected:

1.  a wild-type allele in the FAM channel

2.  a mutant allele in the HEX channel

MUTANT HOMOZYGOTE–   only a mutant allele in the HEX 

channel is detected

/ EVALUATION

WILD-TYPE HOMOZYGOTE–   only a wild-type allele in the FAM 

channel is detected

GENETIC DIAGNOSTICS

46 PRODUCT CATALOGUE | 2018 Thrombotic Mutations



GeneProof Factor II Prothrombin PCR Kit real-time PCR – FII/050 FII/100

GeneProof Factor II Prothrombin PCR Kit

/ The PCR kit is designed to detect G20210A polymorphism of the gene for human factor II prothrombin by the real time Polymerase Chain Reaction (PCR) method.

The method consists in amplification and detection of the target sequence using allele specific fluorophore labelled probes. The target sequence is the single nucleotide guanine/adenine polymorphism in site 20210 (G20210A). Presence of wild-type allele (G20210G) is detected in the FAM fluorescent channel and mutant allele (A20210A) in the HEX fluorescent channel. In case of heterozygous genotype (G20210A) a signal is detected in both channels. Detection kit contains Ready to Use MasterMix and takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Kit is designed for in vitro diagnostics.



Target Sequence G20210A polymorphism of factor II prothrombin

Sensitivity reaches up to 2 ng/μl

Diagnostic Specificity 100 %

Diagnostic Sensitivity 100 %

Evaluation G/G – standard homozygote (wild type)A/A – mutant homozygoteA/G – heterozygote

Validated Specimen * whole blood



Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLineGene 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000SLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System



External Quality Assessment regularly tested by Instand e.V. External Quality Assessment panels – results at www.geneproof.com


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47PRODUCT CATALOGUE | 2018Thrombotic Mutations

www.geneproof.com



GeneProof Factor V Leiden PCR Kit real-time PCR – FV/050 FV/100

GeneProof Factor V Leiden PCR Kit

/ The PCR kit is designed to detect G1691A polymorphism in the gene for human factor V Leiden by the real-time Polymerase Chain Reaction (PCR) method.

The method consists in amplification and detection of the target sequence using allele specific fluorophore labelled probes. The target sequence is a single nucleotide guanine/adenine polymorphism in site 1691 (G1691A). Presence of wild-type allele (G1691G) is detected in the FAM fluorescent channel and mutant allele (A1691A) in the HEX fluorescent channel. In case of heterozygous genotype (G1691A) a signal is detected in both channels. Detection kit contains Ready to Use MasterMix and takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Kit is designed for in vitro diagnostics.



Target Sequence G1691A polymorphism of factor V Leiden




Evaluation G/G – standard homozygote (wild type)A/A – mutant homozygoteG/A – heterozygote




Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000SLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System





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Target Sequence G103T (V34L) polymorphism of the F13A1 gene




Evaluation G/G – standard homozygote (wild type)T/T – mutant homozygoteG/T – heterozygote




Validated Instruments * croBEE Real-Time PCR SystemAriaMx Real-Time PCR SystemLightCycler® 2.0LineGene 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / QSLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System




GeneProof Factor XIII V34L PCR Kit

/ The PCR kit is designed to detect polymorphism of the F13A1 gene encoding the subunit A of FXIII factor by the real-time Polymerase Chain Reaction (PCR) method.

The method consists in amplification and detection of the target sequence using allele specific fluorophore labelled probes. The target sequence is the single nucleotide guanine/thymine polymorphism in site 103 (G103T). Presence of wild-type allele (G103G) is detected in the FAM fluorescent channel and mutant allele (T103T) in the HEX fluorescent channel. In case of heterozygous genotype (G103T) a signal is detected in both channels. Detection kit contains Ready to Use MasterMix and takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Kit is designed for in vitro diagnostics.



GeneProof Factor XIII V34L PCR Kit real-time PCR – FXIII/050 FXIII /100

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www.geneproof.com



Target Sequence C677T polymorphism in the gene for methylenetetrahydrofolate reductase (MTHFR)




Evaluation C/C – standard homozygote (wild type)T/T – mutant homozygoteC/T – heterozygote




Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemLightCycler® 2.0 / 480LineGene 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / 6000SLAN® Real-Time PCR SystemStepOne™ / StepOnePlus™ Real-Time PCR System





GeneProof MTHFR C677T PCR Kit

/ The PCR kit is designed to detect C677T polymorphism in the gene for methylenetetrahydrofolate reductase (MTHFR) by the real-time Polymerase Chain Reaction (PCR).

The method consists in amplification and detection of the target sequence using allele specific fluorophore labelled probes. The target sequence is the single nucleotide cytosine/thymine polymorphism in site 677 (C677T). Presence of wild-type allele (C677C) is detected in the FAM fluorescent channel and mutant allele (T677T) in the HEX fluorescent channel. In case of heterozygous genotype (C677T) a signal is detected in both channels. Detection kit contains Ready to Use MasterMix and takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Kit is designed for in vitro diagnostics.



GeneProof MTHFR C677T PCR Kit real-time PCR – M677/050 M677/100

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Target Sequence A1298C polymorhism in the gene for methylenetetrahydrofolate reductase (MTHFR)




Evaluation A/A – standard homozygote (wild type)C/C – mutant homozygoteA/C – heterozygote




Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0LineGene 9600 / 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / QSLAN® Real-Time PCR System







GeneProof MTHFR A1298C PCR Kit real-time PCR – M1298/050 M1298/100

GeneProof MTHFR A1298C PCR Kit

/ The PCR kit is designed to detect A1298C polymorpism in the gene for methylenetetrahydrofolate reductase (MTHFR) by the real-time Polymerase Chain Reaction (PCR).

The method consists in amplification and detection of the target sequence using allele specific fluorophore labelled probes. The target sequence is the single nucleotide adenine/cytosine polymorphism in site 1298 (A1298C). Presence of wild-type allele (A1298A) is detected in the FAM fluorescent channel and mutant allele (C1298C) in the HEX fluorescent channel. In case of heterozygous genotype (A1298C) a signal is detected in both channels. Detection kit contains Ready to Use MasterMix and takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Kit is designed for in vitro diagnostics.

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www.geneproof.com



Target Sequence polymorphism in promoter of the PAI-1 gene in site 675




Evaluation 5G/5G – standard homozygote (wild type)4G/4G – mutant homozygote4G/5G – heterozygote




Validated Instruments * croBEE Real-Time PCR SystemApplied Biosystems 7300 / 7500 Real-Time PCR SystemAriaMx Real-Time PCR SystemCFX Connect™ / CFX96™ / Dx Real-Time PCR Detection SystemLightCycler® 2.0 / 480LineGene 9600 PlusQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000 / QSLAN® Real-Time PCR System







GeneProof PAI-1 Genotyping PCR Kit real-time PCR – PAI/050 PAI/100

GeneProof PAI-1 Genotyping PCR Kit

/ The PCR kit is designed to detect polymorphism in promoter of the PAI-1 gene by the real-time Polymerase Chain Reaction (PCR) method.

The method consists in amplification and detection of the target sequence using allele specific fluorophore labelled probes. The target sequence is insertion-deletion polymorphism of guanosine 4G/5G in site 675. Presence of wild-type allele (5G/5G) is detected in the FAM fluorescent channel and mutant allele (4G/4G) in the HEX fluorescent channel. In case of heterozygous genotype (4G/5G) a signal is detected in both channels. Detection kit contains Ready to Use MasterMix and takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Kit is designed for in vitro diagnostic.

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52 PRODUCT CATALOGUE | 2018 Pharmacogenetics



GeneProof Warfarin dose VKORC/CYP2C9 PCR Kit real-time PCR WARF/025 WARF/050 WARF/100



Target Sequence single nucleotide polymorphisms CYP2C9*2 (C/T), CYP2C9*3 (A/C), VKORC1 (G/A)




Evaluation CYP2C9*2C/C– standard homozygote (wild type)T/T – mutant homozygoteC/T – heterozygote

CYP2C9*3A/A – standard homozygote (wild type)C/C – mutant homozygoteA/C – heterozygote

VKORC1G/G – standard homozygote (wild type)A/A – mutant homozygoteG/A – heterozygote




Validated Instruments * AriaMx Real-Time PCR SystemQuantStudio™ 3 Real-Time PCR SystemRotor-Gene 3000SLAN® Real-Time PCR System





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GeneProof Warfarin dose VKORC/CYP2C9 PCR Kit

/ The PCR kit is designed to detect polymorphism in the sub-unit 1 of the vitamin K epoxide reductase enzyme complex and allelic variants of the gene encoding the P450 2C9 cytochrome by the real-time Polymerase Chain Reaction (PCR).

The method is based on amplification and detection of the target sequences of VKORC and CYP2C9 genes using allele specific fluorophore labelled probes. The target sequences are located in VKORC1 (G1639A) gene and allelic variants CYP2C9*2 (C430T) and CYP2C9*3 (A1075C) of the gene encoding the P450 2C9 cytochrome. Presence of wild-type allele (for each system) is detected in the FAM fluorescent channel and mutant allele in the HEX fluorescent channel. In case of heterozygous genotype a signal is detected in both channels. Detection kit contains Ready to Use MasterMix and takes advantage of the "hot start" technology minimizing non-specific reactions and assuring maximum sensitivity. The polymorphism of the genes VKORC1 and CYP2C9 significantly impact genetic component of individual sensitivity to Warfarin. Kit is designed for in vitro diagnostics.

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www.warfarindose.com

It is possible to use an application for calculating genetic and non-genetic influences for the establishment of an optimum Warfarin daily dose.

WarfarinDose CalculatorPopulation

Caucasian

Calculate

Age (years)

53Height (cm)

183 Weight (kg)

117CYP2C9*2 (430C>T)CC - wild-type

VKORC1 (1639G>A)GA - heterozygote

CYP2C9*3 (1075A>C)AC - heterozygote

Amiodaron

Yes


53PRODUCT CATALOGUE | 2018Oncogenetic Diagnostics

www.geneproof.com

GeneProof Oncogenetic Diagnostics Technology

/ SAMPLE

positive sample contains  BCR/ABL positive mRNA  mRNA of human ABL gene

/ RNA ISOLATION

after the isolation the extracted sample RNA is added into the Ready to Use MasterMix and the tube is inserted into the real-time device

/ RT-PCR AMPLIFICATION

during RT-PCR, BCR/ABL positive mRNA is amplified from one primer pair  and control human mRNA amplified from the other primer pair

POSITIVE SAMPLE–   fluorescence growth of the FAM / Cy5 /Texas Red fluorophore 

is evident if the BCR/ABL positive mRNA is present in the sample

QUALITY CONTROL FOR THE COMPLETE DIAGNOSTIC PROCESS–   growth of the HEX fluorophore fluorescence (as a result 

of the control RNA amplification) controls the following:

1.  sample quality – sample RNA was not degraded2.  RNA extraction quality – sample RNA was extracted with 

sufficient efficiency3.  RT-PCR amplification quality – sample RNA was efficiently 

amplified, no PCR inhibition

/ EVALUATION

ABLBCR/ABL

54 PRODUCT CATALOGUE | 2018 Oncogenetic Diagnostics

GeneProof BCR/ABL Detection PCR Kit

/ The PCR kit is designed for qualitative detection of the BCR/ABL fusion gene by the one-step RT real-time Polymerase Chain Reaction (PCR) method.

Method consists in amplification and detection of target sequences using allele specific fluorophore labelled probes. The fusion gene BCR/ABL variants are distinguished by using different fluorophores. The Major variant (Mbcr, p210) target sequence is detected in FAM fluorescent channel, the Minor variant (mbcr, p190) in the Cy5 fluorescent channel and the Micro variant (µBCR, p230) in the Texas Red channel. To control sample quality, RNA extraction process and RT-PCR process the kit uses the mRNA detection of the gene for human ABL. Amplification of this control mRNA is visualized in the HEX channel. This detection technology of the naturally occurring human mRNA provides control of the whole diagnostic process, i.e. sample quality (sample RNA degradation), RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into cDNA) and PCR amplification efficiency (PCR inhibition). The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Kit is designed for in vitro diagnostics and provides qualitative detection.

Technology one-step RT real-time PCR


Target Sequence BCR/ABL fusion gene

Specificity Major (b3a2, b2a2), Minor (e1a2), Micro (c3a2)

Sensitivity 0.01 % BCR/ABL positive cells

Extraction/Inhibition Control control of PCR inhibition and quality of RNA extraction

Validated Specimen * whole blood, bone marrow


Validated Extraction Method croBEE NA16 Nucleic Acid Extraction System

Validated Instruments * croBEE Real-Time PCR System

Required Detection Channels FAM, HEX, Cy5, Texas Red


External Quality Assessment regularly tested by Institute of Hematology and Blood Transfusion (IHBT) Prague External Quality Assessment panels – results at www.geneproof.com


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GeneProof BCR/ABL Detection PCR Kit one-step RT real-time PCR BCRABL/025 BCRABL/050 BCRABL/100

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NEW PRODUCT


55PRODUCT CATALOGUE | 2018Oncogenetic Diagnostics

www.geneproof.com

GeneProof BCR/ABL Major PCR Kit

/ The PCR kit is designed for quantitative detection of the p210 transcripts of the BCR/ABL fusion gene by the real-time Polymerase Chain Reaction (PCR) method.

Method consists in amplification and detection of the target sequences of the Major variant (Mbcr, p210) of the BCR/ABL fusion gene using allele specific fluorophore labelled probes. The fusion gene BCR/ABL (transcript types b3a2, b2a2) target sequences are detected in FAM fluorescent channel. To control sample quality, RNA extraction process and RT-PCR process the kit uses the mRNA detection of the gene for human ABL. Amplification of this control mRNA is visualized in the HEX channel. This detection technology of the naturally occurring human mRNA provides control of the whole diagnostic process, i.e. sample quality (sample RNA degradation), RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into cDNA) and PCR amplification efficiency (PCR inhibition). The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. The test is suitable for determining the level of patient’s molecular response to applied treatment, long-term monitoring of the minimal residual disease and possible relapse prediction. Kit is designed for in vitro diagnostics and provides both qualitative and quantitative detection.

IN DEVELOPMENT

GeneProof BCR/ABL Minor PCR Kit

/ The PCR kit is designed for quantitative detection of the p190 transcripts of the BCR/ABL fusion gene by the real-time Polymerase Chain Reaction (PCR) method.

Method consists in amplification and detection of the target sequences of the Minor variant (mbcr, p190) of the BCR/ABL fusion gene using allele specific fluorophore labelled probes. The fusion gene BCR/ABL (transcript type e1a2) target sequences are detected in FAM fluorescent channel. To control sample quality, RNA extraction process and RT-PCR process the kit uses the mRNA detection of the gene for human ABL. Amplification of this control mRNA is visualized in the HEX channel. This detection technology of the naturally occurring human mRNA provides control of the whole diagnostic process, i.e. sample quality (sample RNA degradation), RNA extraction efficiency, reverse-transcription step efficiency (transcription of RNA into cDNA) and PCR amplification efficiency (PCR inhibition). The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. The test is suitable for determining the level of patient’s molecular response to applied treatment, long-term monitoring of the minimal residual disease and possible relapse prediction. Kit is designed for in vitro diagnostics and provides both qualitative and quantitative detection.

IN DEVELOPMENT

We have been developing these products. We will inform you of the new products launch.

57PRODUCT CATALOGUE | 2018Prenatal Diagnostics

www.geneproof.com

GeneProof Prenatal Diagnostics Technology

1 1: 2 1: 1 1: 1:

DIALLELICPROFILE

TRIALLELICPROFILE

TRIALLELICPROFILE

NON-INFORMATIVEPROFILE

/ SAMPLE

amniotic fluid peripheral blood chorionic villi

/ ISOLATION

the extracted sample DNA  is added into the Ready to Use MasterMix after the isolation

/ QF-PCR AMPLIFICATION

individual alleles are amplified in the course of PCR by fluorescence-labelled primers

/ EVALUATION

/ CAPILLARY ELECTRO-PHORESIS

TRIALLELIC PROFILE–   two peaks (two different alleles) where 

one has twice the height (surface area) of the other (1:2 or 2:1 ratio)

–   three different alleles with the same height (surface area), 1:1:1 ratio

DIALLELIC PROFILE–   two peaks of similar height (surface 

area), whose ratio is evaluated as 1:1

NON-INFORMATIVE PROFILE– alleles with the same length

feature just one peak (homozygote)

58 PRODUCT CATALOGUE | 2018 Prenatal Diagnostics

GeneProof OmniPlex QF PCR Kit

/ The QF PCR kits are designed for quick diagnostics of chromosome 13, 18, 21 aneuploidy and sex chromosome aneuploidy.

These aneuploidies represent over 80 % of all significant chromosomal aberrations related to serious genetic disorders such as Down syndrome, Edwards syndrome, Patau syndrome, Turner syndrome, Klinefelter syndrome, etc.

The multiplex QF-PCR (Quantitative-fluorescent Polymerase Chain Reaction) method is based on the amplification of a large number of fluorophore labelled DNA fragments (STR markers) at chromosomes during a single reaction.

Besides the basic version of the GeneProof OmniPlex QF PCR Kit we offer alternative kit versions to be used in case of insufficiently informative results from an examination performed using the GeneProof OmniPlex QF-PCR Kit or for pathology detection verification. You can use the alternative versions independently as well; selection of a suitable diagnostic kit version depends on the individual customer’s requirements.

GeneProof OmniPlex 13plus QF PCR Kit

The multiplex QF-PCR (Quantitative-fluorescent Polymerase Chain Reaction) method is based on the amplification of a large number of fluorophore labelled DNA fragments (STR markers) specific for chromosome 13. Chromosome 13 aneuploidy is one of the most frequent chromosomal aberration associated with serious fetal disorders (Patau syndrome).


The multiplex QF-PCR (Quantitative-fluorescent Polymerase Chain Reaction) method is based on the amplification of a large number of fluorophore labelled DNA fragments (STR markers) specific for chromosome 18. Chromosome 18 aneuploidy is one of the most frequent chromosomal aberration associated with serious fetal disorders (Edwards syndrome).


The multiplex QF-PCR (Quantitative-fluorescent Polymerase Chain Reaction) method is based on the amplification of a large number of fluorophore labelled DNA fragments (STR markers) specific for chromosome 21. Chromosome 21 aneuploidy is one of the most frequent chromosomal aberration associated with serious fetal disorders (Down syndrome).

GeneProof OmniPlex XYplus QF PCR Kit

The multiplex QF-PCR (Quantitative-fluorescent Polymerase Chain Reaction) method is based on the amplification of a large number of fluorophore labelled DNA fragments (STR markers) specific for X and Y sex chromosomes. Chromosome X and Y aneuploidies belong among the most frequent chromosomal aberrations associated with serious genetic fetal disorders (Turner syndrome, Klinefelter syndrome).

59PRODUCT CATALOGUE | 2018Prenatal Diagnostics

www.geneproof.com

Technology QF PCRfragmentation analysis

Target Sequence 25 STR loci DNA sequences at the 13, 18, 21, X and Y chromosomes

Qualitative Detection mutation present × not present

Evaluation Homozygote – alleles with the same length feature just one peakHeterozygote – alleles with various lengths for specific STR sequences, two peaks with the same height/surface area (1:1 ratio) and different lengthsDisomy – the result shall be evaluated as normal, if at least two informative markers match the diallelic genotype; the other markers are non-informative. The diallelic profile is specified using markers with two peaks of similar height/surface area, whose ratio is evaluated as 1:1Trisomy – three different alleles with the same height/surface area (1:1:1 ratio) or two peaks (two different alleles) where one has twice the height/surface area of the other (1:2 or 2:1 ratio)

Specimen whole blood, amniotic fluid, tissue

Kit Storage -85 °C to -10 °C

Extraction Method QIAamp DNA Mini Mit (Qiagen)QIAamp DNA Blood Mini Kit (Qiagen)

Supported Devices ** Applied Biosystems 310 Genetic AnalyzerApplied Biosystems 3100 Genetic AnalyzerApplied Biosystems 3130 Genetic AnalyzerApplied Biosystems 3500 Genetic Analyzer


External Quality Assessment regularly tested by IExternal Quality Assessment panels – results at www.geneproof.com

** GeneProof OmniPlex QF PCR Kit has been designed for use with Applied Biosystems genetic analyzers supporting 5-Dye Data Collection



GeneProof Omniplex QF PCR KitQF PCRfragmentation analysis

OMNI/025 OMNI/050 OMNI/100

GeneProof OmniPlex 13plus QF PCR KitQF PCRfragmentation analysis

OMNI13/025 – –


OMNI18/025 – –


OMNI21/025 – –

GeneProof OmniPlex XYplus QF PCR KitQF PCRfragmentation analysis

OMNIXY/025 – –

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GeneProof PCR kits are validated for a wide range of real-time devices from various manufacturers• croBEE Real-Time PCR System (GeneProof)

• Applied Biosystems 7300 / 7500 Real-Time PCR System (Life Technologies)

• AriaMx Real-Time PCR System (Agilent Technologies)

• CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System (Bio-Rad)

• DTlite Real-Time PCR System (DNA-Technology LLC)

• LightCycler® 2.0 / 480 (ROCHE)

• LineGene 9600 / 9600 Plus (Hangzhou Bioer Technology Co., Ltd.)

• Rotor-Gene 3000 / 6000 / Q (QIAGEN)

• SLAN® Real-Time PCR System (Shanghai Hongshi Medical Technology Co., Ltd.)

• StepOne™ Real-Time PCR System (Thermo Fisher Scientific)

• VERSANT® kPCR Molecular System (Siemens)

GeneProof diagnostic kits are continually validated with various types of devices.Current overview is available at www.geneproof.com, or please request the current list at [email protected]

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www.geneproof.com

GeneProof Manual DNA/RNA Extraction Technology

NUCLEIC ACID EXTRACTIONS

/ SAMPLE LYSIS

a sample is lyzed at the presence of chaotropic ions and proteinase K

/ NUCLEIC ACID BINDING

the released DNA/RNA is bound to the silica membrane in the column

/ SILICA MEMBRANE WASHING

the bound DNA/RNA is purified of cellular residua

/ NUCLEIC ACID ELUTION

the clean DNA/RNA is released from the silica membrane into the elution buffer and ready for further applications

62 PRODUCT CATALOGUE | 2018 Nucleic Acid Extractions

GeneProof PathogenFree DNA Isolation Kit

/ The kit for the column DNA isolation.

The kit is designed to be used in diagnostic and research laboratories dealing with routine PCR diagnostics of pathogenic microorganisms (bacteria, candidas and fungi, viruses and protozoa) or in human genetic diagnostics. Owing to a special column design the kit provides user simple, efficient and very quick DNA isolation from clinical materials without any microbial DNA contamination. The kit is designed mostly for the DNA isolation from whole peripheral blood, sputum and synthetic sputum, urine, smear and swab, bronchoalveolar lavage (BAL), cerebrospinal fluid (CSF, liquor) and synthetic CSF, saliva and biopsy.

/ The kit for column RNA isolation.

The kit is designed for use in diagnostic and research laboratories dealing with routine PCR diagnostics of RNA viruses. Owing to a special column design the kit provides user simple, efficient and very quick RNA isolation from clinical material. The kit is designed mostly for RNA isolation from serum and plasma.


50 isolations 250 isolations

GeneProof PathogenFree RNA Isolation Kit isolation IRNA050 IRNA250



GeneProof PathogenFree DNA Isolation Kit isolation IDNA050 IDNA250

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Hepatitis B Virus,BK/JC Virus,

Cytomegalovirus,Epstein-Barr Virus,Borrelia burgdorferi,

Chlamydia trachomatis,Factor II Prothrombin,PAI-1 Genotyping,

etc.

GeneProof PathogenFree DNA Isolation Kit

/ CLINICAL MATERIAL

the isolation process is universal and suitable for nucleic acids extraction from many types of clinical material

/ UNIVERSAL ISOLATION PROTOCOL

/ DETECTION

the purified nucleic acid can be subsequently used for various types of detection

whole peripheral blood,sputum/synthetic sputum,

urine, smear/swab,bronchoalveolar lavage (BAL),

cerebrospinal fluid (CSF, liquor)/synthetic CSF,

saliva, biopsy,etc.

GeneProof PathogenFree RNA Isolation Kit

INSTRUMENTS


www.geneproof.com

A B C D E

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croBEE Universal Solution

Compatibility of the croBEE extraction process with GeneProof real-time PCR diagnostics and universality of the complete GeneProof diagnostic solution offers you the option to assemble the diagnostic process precisely according to the needs of your laboratory and minimizes time and personnel costs related to the diagnostic process.

CROBEE

The complete process takes about 4 hours

Design your multiplex detection

   HBV / plasma

   EBV / whole blood

   CMV / serum

   BB / CSF

   TBC / sputum

   NG / urine

   MP / aspirate

   HPV / cervix swab

…

…

1  Mycobacterium tuberculosis

2  Borrelia burgdorferi

3  Epstein-Barr Virus (EBV)

4  Cytomegalovirus (CMV)

5  Neisseria gonorrhoeae

6  Mycoplasma pneumoniae

7  Human Papillomavirus (HPV)

8  …

A  Plasma

B  Sputum

C  CSF

D  Whole blood

E  Serum

F  Urine

G  Aspirate

H  Cervix swab

I  …

/ UNIFORM EXTRACTION PROCEDURE

A universal extraction 

protocol makes it possible 

to simultaneously extract DNA and 

RNA from various types of input 

materials during a single run

of the croBEE NA16 Nucleic Acid 

Extraction System.

/ SINGLE AMPLIFICATION PROFILE

• for microbiological 

RNA diagnostics

• for microbiological 

DNA diagnostics

• for genetic diagnostics

1 2 3 4 5 6 7 8

64 PRODUCT CATALOGUE | 2018 croBEE NA

croBEE Automated DNA/RNA Extraction Technology

/ SAMPLE LYSIS

A sample is lysed in the presence of lysis buffer and proteinase K.

/ NUCLEIC ACID BINDING

Released DNA/RNA is bound to magnetic beads.

/ MAGNETIC BEADS WASHING

The magnetic beads are immobilised and released during sample lysis, washing and elution steps. DNA/RNA is purified from cellular residua during washing step.

/ ELUTION

The nucleic acid is released from magnetic beads into an elution buffer. This high-purity nucleic acid is suitable for subsequent molecular-biology applications.

65PRODUCT CATALOGUE | 2018croBEE NA

www.geneproof.com

Product name Technology Cat. No. Package

croBEE NA16 Nucleic Acid Extraction System fully automated magnetic separation CBNA/16 1 piece

croBEE 201 A Nucleic Acid Extraction Kit fully automated magnetic separation CBNA201A/096 96 isolations

croBEE NA16 Nucleic Acid Extraction System

/ croBEE NA16 Nucleic Acid Extraction System is a compact, fully automated system for simultaneous nucleic acid extraction from a wide range of biological materials.

The extraction principle is based on the nucleic acid binding to paramagnetic particles. Easy handling is provided by a disposable reagent cartridge containing all the necessary chemical agents. The extraction process results in high-quality DNA/RNA with highly reproducible yields.

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Extraction Principle fully automated magnetic separation

Reagent Application Method disposable reagent cartridge

Sample Volume 200 µl / 400 µl / 1200 µl

Elution Volumes 60 µl / 100 µl / 150 µl / 200 µl

Capacity 1–16 samples/extraction process

Processing Time 44–80 minutes

Nucleic Acid Purity DNA: OD A260/280 ratio 1.8 ± 0.1RNA: OD A260/280 ratio 2.0 ± 0.2

Heating Block Temperature Range RT – 90 °C

Computer integrated PC

User Interface and Control 7˝ colour touch screen

Decontamination built-in UV lamp

Dimensions 760×710×770 mm (W×D×H)

Weight 68.5 kg

Power Supply 100–240 V, 50/60 Hz, 1 kW

Device Type stand-alone device


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• Highly reproducible yields of nucleic acids

• Elimination of faults caused by the operator

• Cross-contamination effect minimization

• Cost-effective solution

croBEE 201 A Nucleic Acid Extraction Kit

/ The kit is designed for DNA/RNA extraction using the croBEE NA16 Nucleic Acid Extraction System.

It provides simultaneous nucleic acids extraction from various biological material types due to the universal reagent cartridge. All the necessary reagents and consumables are included in the package. All components, plastics and disposable reagent cartridges contained in the croBEE 201 A Nucleic Acid Extraction Kit are DNase/RNase-Free.

66 PRODUCT CATALOGUE | 2018 croBEE RT

croBEE Real-Time PCR System

Sample Capacity 96-well PCR plate, 12×8-strip,

96×0.2 ml (transparent bottom)

Excitation Wavelength 300–800 nm

Emission Wavelength 500–800 nm

Detected Fluorescence F1: FAM, SYBR Green 1F2: HEX, VIC, TET, JOE, Cy3, NED, TAMRAF3: ROX, Texas RedF4: Cy5F5: Cy5.5

Temperature Block Range 4–105 °C (minimum increment: 0.1 °C)

Heating/Cooling Rate 4.0 °C/s

Temperature Control Accuracy ≤±0.1 °C

Temperature Fluctuation ≤±0.1 °C

Temperature Uniformity ≤±0.3 °C

Temperature Control Mode BLOCK / tube simulation mode (based on sample volume)

Sample Volume Range 5–100 µL

Temperature Gradient Range 1–36 °C

Hot Lid Temperature Range 30–110 °C (adjustable, default 105 °C, automatic hot lid)

Fluorescence Detection Repeatability 5 %

Feature Functions absolute quantification, relative quantification, SNP analysis, HRM analysis, automatic data analysis, melting curve, temperature gradient, automatic/customized gain, multiple file gene expression analysis

Power Supply 100–240 V, 50/60 Hz, 600 W

Dimensions 386×415×380 mm (W×D×H)

Weight 31 kg


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/ croBEE RT is a fully integrated PCR system with the capacity of 96 samples designed for nucleic acids amplification and detection and complex analysis of obtained data.

The system works with the Peltier elements. The fluorescence signal is detected by a highly sensitive optical array detecting a wide range of fluorescence. Thanks to systems managing optical and temperature parameters, high detection accuracy and high results reproducibility is ensured.

• High temperature control accuracy & stability

• Dual high-sensitivity synchronous detection

• Unique constant pressure hot lid system

• Long-life led light source

• Maximum 36 °C temperature gradient control function

• Professional analysis software


croBEE Real-Time PCR System real-time PCR CBRT4/96 1 piece


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www.geneproof.com

Customer Care

Contacts

We appreciate all our customers and besides high-quality products we provide, in cooperation with our partners, above-standard customer service including the following:

• Demonstration PCR kits

• Express deliveries

• Quick solution of issues related to the supplied products – service 

guaranteed within 24 hours from the time of report

• Consultations concerning technological and clinical interpretations

To assure the quickest possible solution of any issue we always require the GeneProof PCR Kit users to provide the following information:

• Kit name

• Issue definition

• Kit lot – specified on the kit package

• Used device

• File with the examination log from the used device, if available

Headquarters

GeneProof a.s.

Vídeňská 101/119, Dolní Heršpice, 619 00 Brno

Czech Republic

VAT ID CZ26981947

+420 543 211 679 PHONE

+420 516 770 824 FAX

[email protected] E-MAIL

www.geneproof.com

Business department / Orders

+420 543 211 679 PHONE

+420 516 770 824 FAX


Support and customer care

+420 543 211 679 PHONE

+420 516 770 824 FAX




Microbiological RNA Diagnostics

Hepatitis C Virus (HCV)

GeneProof Hepatitis C Virus (HCV) PCR Kit one-step RT real-time PCR – HCV/PLUS/025 HCV/PLUS/050 HCV/PLUS/100

HIV type 1 (HIV-1)

GeneProof HIV type 1 (HIV-1) PCR Kit one-step RT real-time PCR – HIV1/ISEX/025 HIV1/ISEX/050 HIV1/ISEX/100

Microbiological DNA Diagnostics

Adenovirus

GeneProof Adenovirus PCR Kit real-time PCR – ADV/ISIN/025 ADV/ISIN/050 ADV/ISIN/100

GeneProof Adenovirus PCR Kit real-time PCR – ADV/ISEX/025 ADV/ISEX/050 ADV/ISEX/100

Aspergillus

GeneProof Aspergillus PCR Kit real-time PCR – ASP/ISIN/025 ASP/ISIN/050 ASP/ISIN/100

GeneProof Aspergillus PCR Kit real-time PCR – ASP/ISEX/025 ASP/ISEX/050 ASP/ISEX/100

GeneProof Aspergillus Sample Pretreatment Set Pretreatment Set ASP/010 – – –

BK Virus (BKV)

GeneProof BK Virus (BKV) PCR Kit real-time PCR – BKV/ISIN/025 BKV/ISIN/050 BKV/ISIN/100

GeneProof BK Virus (BKV) PCR Kit real-time PCR – BKV/ISEX/025 BKV/ISEX/050 BKV/ISEX/100

BK/JC Virus (BK/JC)

GeneProof BK/JC Virus (BK/JC) PCR Kit real-time PCR – BKJC/ISIN/025 BKJC/ISIN/050 BKJC/ISIN/100

GeneProof BK/JC Virus (BK/JC) PCR Kit real-time PCR – BKJC/ISEX/025 BKJC/ISEX/050 BKJC/ISEX/100

Bordetella pertussis/parapertussis

GeneProof Bordetella pertussis/parapertussis PCR Kit real-time PCR – BP/ISIN/025 BP/ISIN/050 BP/ISIN/100

GeneProof Bordetella pertussis/parapertussis PCR Kit real-time PCR – BP/ISEX/025 BP/ISEX/050 BP/ISEX/100

Borrelia burgdorferi

GeneProof Borrelia burgdorferi PCR Kit real-time PCR – BB/ISIN/025 BB/ISIN/050 BB/ISIN/100

GeneProof Borrelia burgdorferi PCR Kit real-time PCR – BB/ISEX/025 BB/ISEX/050 BB/ISEX/100

Cytomegalovirus (CMV)

GeneProof Cytomegalovirus (CMV) PCR Kit real-time PCR – CMV/ISIN/025 CMV/ISIN/050 CMV/ISIN/100

GeneProof Cytomegalovirus (CMV) PCR Kit real-time PCR – CMV/ISEX/025 CMV/ISEX/050 CMV/ISEX/100

Epstein-Barr Virus (EBV)

GeneProof Epstein-Barr Virus (EBV) PCR Kit real-time PCR – EBV/ISIN/025 EBV/ISIN/050 EBV/ISIN/100

GeneProof Epstein-Barr Virus (EBV) PCR Kit real-time PCR – EBV/ISEX/025 EBV/ISEX/050 EBV/ISEX/100

ESBL

GeneProof ESBL PCR Kit real-time PCR – ESBL/ISIN/025 ESBL/ISIN/050 ESBL/ISIN/100

GeneProof ESBL PCR Kit real-time PCR – ESBL/ISEX/025 ESBL/ISEX/050 ESBL/ISEX/100

Hepatitis B Virus (HBV)

GeneProof Hepatitis B Virus (HBV) PCR Kit real-time PCR – HBV/ISEX/025 HBV/ISEX/050 HBV/ISEX/100

Herpes Simplex Virus (HSV-1/2)

GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit real-time PCR – HSV/ISIN/025 HSV/ISIN/050 HSV/ISIN/100

GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit real-time PCR – HSV/ISEX/025 HSV/ISEX/050 HSV/ISEX/100

Herpes Simplex Virus 1 (HSV-1)

GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit real-time PCR – HSV1/ISIN/025 HSV1/ISIN/050 HSV1/ISIN/100

GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit real-time PCR – HSV1/ISEX/025 HSV1/ISEX/050 HSV1/ISEX/100

Herpes Simplex Virus 2 (HSV-2)

GeneProof Herpes Simplex Virus 2 (HSV-2) PCR Kit real-time PCR – HSV2/ISIN/025 HSV2/ISIN/050 HSV2/ISIN/100

GeneProof Herpes Simplex Virus 2 (HSV-2) PCR Kit real-time PCR – HSV2/ISEX/025 HSV2/ISEX/050 HSV2/ISEX/100

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68 PRODUCT CATALOGUE | 2018

www.geneproof.com



Human Herpesvirus 6/7 (HHV-6/7)

GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit real-time PCR – HHV/ISIN/025 HHV/ISIN/050 HHV/ISIN/100

GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit real-time PCR – HHV/ISEX/025 HHV/ISEX/050 HHV/ISEX/100

Human Herpesvirus 8 (HHV-8)

GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit real-time PCR – HHV8/ISIN/025 HHV8/ISIN/050 HHV8/ISIN/100

GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit real-time PCR – HHV8/ISEX/025 HHV8/ISEX/050 HHV8/ISEX/100

Human Papillomavirus (HPV)

GeneProof Human Papillomavirus (HPV) PCR Kit real-time PCR – HPVS/ISEX/025 HPVS/ISEX/050 HPVS/ISEX/100

Chlamydia pneumoniae

GeneProof Chlamydia pneumoniae PCR Kit real-time PCR – CHP/ISIN/025 CHP/ISIN/050 CHP/ISIN/100

GeneProof Chlamydia pneumoniae PCR Kit real-time PCR – CHP/ISEX/025 CHP/ISEX/050 CHP/ISEX/100

Chlamydia trachomatis

GeneProof Chlamydia trachomatis PCR Kit real-time PCR – CHT/ISIN/025 CHT/ISIN/050 CHT/ISIN/100

GeneProof Chlamydia trachomatis PCR Kit real-time PCR – CHT/ISEX/025 CHT/ISEX/050 CHT/ISEX/100

JC Virus (JCV)

GeneProof JC Virus (JCV) PCR Kit real-time PCR – JCV/ISIN/025 JCV/ISIN/050 JCV/ISIN/100

GeneProof JC Virus (JCV) PCR Kit real-time PCR – JCV/ISEX/025 JCV/ISEX/050 JCV/ISEX/100

Legionella pneumophila

GeneProof Legionella pneumophila PCR Kit real-time PCR – LP/ISIN/025 LP/ISIN/050 LP/ISIN/100

GeneProof Legionella pneumophila PCR Kit real-time PCR – LP/ISEX/025 LP/ISEX/050 LP/ISEX/100

MRSA

GeneProof MRSA PCR Kit real-time PCR – MRSA/ISIN/025 MRSA/ISIN/050 MRSA/ISIN/100

GeneProof MRSA PCR Kit real-time PCR – MRSA/ISEX/025 MRSA/ISEX/050 MRSA/ISEX/100

Mycobacterium tuberculosis

GeneProof Mycobacterium tuberculosis PCR Kit real-time PCR – MT/ISIN/025 MT/ISIN/050 MT/ISIN/100

GeneProof Mycobacterium tuberculosis PCR Kit real-time PCR – MT/ISEX/025 MT/ISEX/050 MT/ISEX/100

Mycoplasma genitalium/hominis

GeneProof Mycoplasma genitalium/hominis PCR Kit real-time PCR – MGH/ISIN/025 MGH/ISIN/050 MGH/ISIN/100

GeneProof Mycoplasma genitalium/hominis PCR Kit real-time PCR – MGH/ISEX/025 MGH/ISEX/050 MGH/ISEX/100

Mycoplasma pneumoniae

GeneProof Mycoplasma pneumoniae PCR Kit real-time PCR – MP/ISIN/025 MP/ISIN/050 MP/ISIN/100

GeneProof Mycoplasma pneumoniae PCR Kit real-time PCR – MP/ISEX/025 MP/ISEX/050 MP/ISEX/100

Neisseria gonorrhoeae

GeneProof Neisseria gonorrhoeae PCR Kit real-time PCR – NG/ISIN/025 NG/ISIN/050 NG/ISIN/100

GeneProof Neisseria gonorrhoeae PCR Kit real-time PCR – NG/ISEX/025 NG/ISEX/050 NG/ISEX/100

Parvovirus B19

GeneProof Parvovirus B19 PCR Kit real-time PCR – B19/ISIN/025 B19/ISIN/050 B19/ISIN/100

GeneProof Parvovirus B19 PCR Kit real-time PCR – B19/ISEX/025 B19/ISEX/050 B19/ISEX/100

Ureaplasma

GeneProof Ureaplasma PCR Kit real-time PCR – UUP/ISIN/025 UUP/ISIN/050 UUP/ISIN/100

GeneProof Ureaplasma PCR Kit real-time PCR – UUP/ISEX/025 UUP/ISEX/050 UUP/ISEX/100

Varicella-Zoster Virus (VZV)

GeneProof Varicella-Zoster Virus (VZV) PCR Kit real-time PCR – VZV/ISIN/025 VZV/ISIN/050 VZV/ISIN/100

GeneProof Varicella-Zoster Virus (VZV) PCR Kit real-time PCR – VZV/ISEX/025 VZV/ISEX/050 VZV/ISEX/100

VRE

GeneProof VRE PCR Kit real-time PCR – VRE/ISIN/025 VRE/ISIN/050 VRE/ISIN/100

GeneProof VRE PCR Kit real-time PCR – VRE/ISEX/025 VRE/ISEX/050 VRE/ISEX/100

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69PRODUCT CATALOGUE | 2018

Product name TechnologyCat. No.


DNA Extractions

GeneProof PathogenFree DNA Isolation Kit isolation IDNA050 IDNA250

RNA Extractions

GeneProof PathogenFree RNA Isolation Kit isolation IRNA050 IRNA250

NU

CLE

IC A

CID

EX

TRA

CTI

ON

S


croBEE NA

croBEE NA16 Nucleic Acid Extraction System fully automated magnetic separation CBNA/16 1 piece

croBEE 201 A Nucleic Acid Extraction Kit fully automated magnetic separation CBNA201A/096 96 isolations

croBEE RT



CRO

BEE



Thrombotic Mutations

Factor II Prothrombin

GeneProof Factor II Prothrombin PCR Kit real-time PCR – FII/050 FII/100

Factor V Leiden

GeneProof Factor V Leiden PCR Kit real-time PCR – FV/050 FV/100

Factor XIII V34L

GeneProof Factor XIII V34L PCR Kit real-time PCR – FXIII/050 FXIII /100

MTHFR A1298C

GeneProof MTHFR A1298C PCR Kit real-time PCR – M1298/050 M1298/100

MTHFR C677T

GeneProof MTHFR C677T PCR Kit real-time PCR – M677/050 M677/100

PAI-1 Genotyping

GeneProof PAI-1 Genotyping PCR Kit real-time PCR – PAI/050 PAI/100

Pharmacogenetics

Warfarin dose VKORC/CYP2C9

GeneProof Warfarin dose VKORC/CYP2C9 PCR Kit real-time PCR WARF/025 WARF/050 WARF/100

Oncogenetic Diagnostics

BCR/ABL Detection

GeneProof BCR/ABL Detection PCR Kit one-step RT real-time PCR BCRABL/025 BCRABL/050 BCRABL/100

Prenatal Diagnostics

OmniPlex

GeneProof OmniPlex QF PCR Kit QF PCR, fragmentation analysis OMNI/025 OMNI/050 OMNI/100

GeneProof OmniPlex 13plus QF PCR Kit QF PCR, fragmentation analysis OMNI13/025 – –



GeneProof OmniPlex XYplus QF PCR Kit QF PCR, fragmentation analysis OMNIXY/025 – –

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Product List

70 PRODUCT CATALOGUE | 2018

The Quality Management System of GeneProof a.s. is certifi ed to EN ISO 13485.

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2018


Dolní Heršpice619 00 Brno

+420 543 211 679 TEL

+420 516 770 824 FAX



KATALOG PRODUKTŮ

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2018


619 00 BrnoCzech Republic

+420 543 211 679 PHONE

+420 516 770 824 FAX



PRODUCT CATALOGUE

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geneproof catalogue · 2018. 10. 25. · your specialist for pcr diagnostics! molecular diagnostics...

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