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ExiStation™ System 3

AccuPower® Real-Time PCR Diagnostic Kits 7

B-1. Human Immunodeficiency Virus

B-2. Hepatitis Virus

B-3. BCI Blood Screening

B-4. Mycobacterium Tuberculosis

B-5. Sexually Transmitted Infections

B-6. Transplantation related Virus

B-7. Human Papillomavirus

B-8. Respiratory Pathogens

B-9. Gastrointestinal Pathogens

B-10. Human Genotyping

B-11. Chronic Myelogenous Leukemia (CML)

B-12. Mosquito-borne Diseases (ZIKV, DENV and CHIKV)

ExiPrep™ Dx Nucleic Acid Extraction Kits 43

C-1. Viral DNA/RNA Kit

C-2. Blood Viral DNA Kit

C-3. Bacteria Genomic DNA Kit

C-4. Genomic DNA Kit

C-5. Blood Genomic DNA Kit

Ordering Information 49

A

B

C

D

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ExiStation™ System

ExiStation™ Series is a molecular diagnostic platform for various scales of laboratories. This series is composed with ExiStation™, ExiStation™ 48, ExiStation™ 48 A and ExiStation™ HT. All ExiStation™ system have a several common advantages.

● Able to detect tiny copies of viruses in samples owing to built-in quality control system

● Easy process of diagnosis by using pre-installed protocol

● Simultaneous PCR for various target since all AccuPower® kits were optimized to same thermal cycle condition using Exicycler™ 96

● Streamlined workflow using user-friendly ExiStation™ Manager software from sample preparation to data analysis

● Able to handle up to 48 samples with combination of 3 ExiPrep™ 16 Dx and 1 Exicycler™ 96

● Available for simultaneous diagnosis of various diseases : For example HIV, STI and TB can be detected simultaneously as

ExiPrep™ 16 Dx can extract nucleic acid from different specimen at the same time

● Nucleic acid extraction from 48 samples within an hour.● Enhanced usability with built in automatic cartridge puncher and various option of sample volume, 400 and 800 ul● Use primary tube directly: all process is automated such as decapping/capping of sample tube and sample transfer*● Input sample information automatically by using built-in barcoding system*

● All equipments necessary for diagnosis, from nucleic acids extraction to Real-Time PCR, are pre-installed

● Fully automatic system allows real high through-put for up to 9 hours of walk-away time

● Minimized handling step by “Sample-in, Data out” operation● Up to 5 different types of specimen can be used in a single

loading● Able to handle Max. 480 samples in a loading (5 decks)

* Only apply to ExiStation™ 48 A (In development)

ExiStation™ Universal Molecular Diagnostic System

ExiStation™

ExiStation™ 48 / ExiStation™ 48 A

ExiStation™ HT

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Sample Transfer Nucleic acid extraction Real-Time PCR

ExiLT™ BT ExiPrep™ 16 Dx ExiPrep™ 48 Dx Exicycler™ 96

ExiStation™ √ √

ExiStation™ 48 √ √

ExiStation™ 48 A √ √ √

ExiStation™ HT Built-in equipment for all process from NA extraction and Real-Time PCR

Max. No. of test / a day(based on 9-hour workday)

Hands on time(for Extraction)

Extraction™ Hands on time(for PCR)

PCR Analysis

ExiStation™ (with 1 Exiprep™ 16 Dx)

48 tests 15 min 1 hr 30 min 15 min 1 hr 20 min

ExiStation™ (with 2 Exiprep™ 16 Dx)


ExiStation™(with 3 Exiprep™ 16 Dx)


ExiStation™ 48 144 tests 35 min 1 hr 15 min 1 hr 20 min

ExiStation™ 48A 192 tests 5 min 1hr 20 min 15 min 1 hr 20 min

ExiStation™ HT 480 tests 1 hr First 96 samples (1 Deck) : 3 hours Subsequent samples in 96 batch : 1.5 hours

Configuration

Workflow

Through put

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Components

● Random-access system Simultaneous nucleic acid extraction from various types of clinical samples

- Each of 3 ExiPrep™16 Dx extracts different targets at once● 5 different contamination prevention measures● Handle Max. 48 samples in 90 min - Each ExiPrep™16 Dx handles 16 samples in 90 min

● Enhanced usability with built in automatic cartridge puncher ● Various option of sample volume: 100, 400 and 800 ul ● Able to use primary tube by docking ExiLT● Handle Max 48 samples in an hour

● Superior sensitive optics by light polarization, which remove a reflection light, allowing precise quantification and target

● Improved thermal block ramping rate - Reduced run time by 25% (Max. 96 samples in 90 min) - Two types: Normal block (Max 4.5°C/sec), Fast block (Max 5.0°C /sec)● 5 channel multiplex detection without use of a reference dye

● Fully automated spin-mix-spin centrifuge ● Programmable protocol ensures reproducible results● ExiStation™ system includes 1 ExiSpin™; ExiStation™ 48 system includes 2 ExiSpin™

● Control the entire ExiStation™ MDx System from sample preparation to data analysis ● Automatic analysis of different target results for individual samples with LIS connection

ExiPrep™ 16 Dx Fully Automated Nucleic Acid Extraction System

ExiPrep™ 48 Dx

Exicycler™ 96 Real-Time Quantitative Thermal Block

ExiSpin™

ExiStation™ Manager software

Cat. no. Kit name Target

A-2060 Exicycler™ 96 Real-Time Quantitative Thermal Block 96

A-5050 ExiPrep™ 16 Dx Fully Automated Nucleic Acid Extraction System 16

A-5150 ExiPrep™ 48 Dx 48

A-7040 ExiSpin™ 32

Ordering Information

AccuPower® Real-Time PCR Diagnostic Kits···················································································8

B-1. Human Immunodeficiency Virus ···················································································································· 10

B-2. Hepatitis Virus ························································································································································· 11

B-3. BCI Blood Screening ············································································································································· 13

B-4. Mycobacterium Tuberculosis ······························································································································ 14

B-5. Sexually Transmitted Infections ······················································································································· 16

B-6. Transplantation related Virus ···························································································································· 20

B-7. Human Papillomavirus ······································································································································· 23

B-8. Respiratory Pathogens ········································································································································ 25

B-9. Gastrointestinal Pathogens ······························································································································· 29

B-10. Human Genotyping ············································································································································· 31

B-11. Chronic Myelogenous Leukemia (CML) ······································································································ 39

B-12. Mosquito-borne Diseases (ZIKV, DENV and CHIKV)··············································································· 40

* References ······································································································································································· 41

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Features ● Signature Convenience All components for the assay are contained within a tube● Outstanding Stability and Reproducibility Vacuum-dried Premix suspends reagent deterioration and reduces user error● Optimized for Sensitive and Robust Performance Eliminate non-specific DNA amplification by utilizing a proprietary HotStart method● Reliable Results Internal Positive Control (IPC) in each premix tube monitors each assay PCR performance and for possible inhibition

Just add sample!- Real-Time PCR Premix (Including Reaction Buffer, Enzyme, Target Primer/Probe set, Internal Positive Control Primer/Probe set, dNTPs Stabilizer)- Control DNA/RNA (Standard DNA/RNA, Positive Control DNA/RNA, Internal Positive Control DNA/RNA)- DEPC D.W., Optical Sealing Film, Quick Manual

AccuPower® Real-Time PCR Diagnostic Kits are vacuum-dried qPCR and RT-qPCR premixes. All the components necessary for Real-Time PCR are contained within one tube, which increases the stability of reagents and simplifies reaction setup. Due to this simplified setup, AccuPower®technology is ideal for automated molecular diagnostics. Furthermore, AccuPower® Real-Time PCR Diagnostic Kits use proprietary stabilization technology that preserves the full activity of the mixed reagents, and patented HotStart technology (US 14383793) that enhances sensitivity and specificity of the kits.

Components of the kit

AccuPower® Real-Time PCR Diagnostic Kits


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The most important aspects in diagnosis are specificity and sensitivity, which decide accuracy of diagnosis. Since accurate diagnosis will lead to proper treatment. In other words, it is directly related to patient’s health and even lives.

Dual-HotStart™ technology is unique diagnostic technology developed by Bioneer in order to enhance quality and save millions of lives. This technology is a method to detect RNA target from clinical samples with high sensitivity and specificity.This technology utilizes Bioneer’s unique enzyme-mediated HotStart method for both reverse transcription and PCR amplification. Dual-HotStart™ eliminates non-specific cDNA synthesis and non-specific DNA amplification and allows for the most sensitive one-step RT-qPCR assays available.

Figure 1. Serial dilutions of HCV RNA were amplified by conventional RT-PCR (left panel) and Dual-HotStart™ RT-PCR (right panel). The results suggest

that Dual-HotStart™ RT-PCR enables highly sensitive detection of low copies of RNA target by eliminating non-specific cDNA synthesis and non-

specific PCR amplification.

● Dual-HotStart™ RT-qPCR reactions is key technology of accurate diagnosis with Pyro-HotStart RT and HotStart PCR ● Maximize sensitivity by extending the reaction through pyrophosphate cleanup with pyrophosphatase● Increase specificity by preventing non-specific zero-cycle product formation

Dual-HotStart™ Technology

Features


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AccuPower® HIV-1 Quantitative RT-PCR Kit

B-1. Human Immunodeficiency Virus

Human immunodeficiency virus (HIV) is recognized as a known viral agent that causes Acquired Immune Deficiency Syndrome (AIDS). Thus, monitoring of viral load in HIV-1 infection patients is an essential test for establishment of therapeutic strategy and determination of therapeutic progress. The AccuPower® HIV-1 Quantitative RT-PCR Kit is an in vitro diagnostic kit designed for the quantification of HIV-1 RNA in human EDTA-plasma samples through Real-Time polymerase chain reaction (PCR) using ExiStation™ MDx System.

● Target - human immunodeficiency virus type 1 (HIV-1): integrase region of polymerase gene, 5’LTR ● Sample type - EDTA-plasma

● Highly sensitive detection of various HIV-1 subtypes including group M (A, B, C, D, AE, F, AG, G, H, and several CRFs), N and O (Table 1)

- The limit of detection (LoD) is 33.1 IU/ml (subtype B)- The limit of quantification (LoQ) is 50 IU/ml

● One-Step Real-Time RT-PCR reaction using RocketScript™ Reverse Transcriptase and Dual-HotStart™ technology

● High reliability through Internal Positive Control and Low/High Positive Controls

● Simultaneous combination IVD test with Bioneer’s TB and STIs series kits by ExiStation™ Manager software

The AccuPower® HIV-1 Quantitative RT-PCR Kit provides;

HIV-1111 PCR PreMix (96 rxn), SPCs (S1~S5), PCs (LPC, HPC), NTC, SL buffer, Optical sealing film

Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower® HIV-1 Quantitative RT-PCR Kit. Black signal; HIV-1, Blue signal; IPC

Cat. no. Kit name Target Tests

MTN-1111 AccuPower® MTB & NTM Real-Time PCR Kit Mycobacterium tuberculosis, Non-tuberculous mycobacteria 96

STI8A-1111 AccuPower® STI8A-Plex Real-Time PCR KitChlamydia trachomatis, Neisseria gonorrhoeae, Ureaplasma urealyticum, Mycoplasma genitalium

96

STI8B-1111 AccuPower® STI8B-Plex Real-Time PCR Kit Trichomonas vaginalis, Mycoplasma hominis, HSV type 1 and 2 96

Nucleic Acid Extraction Kit using with ExiPrep™16 Dx

K-4471 ExiPrep™ Dx Viral DNA/RNA Kit 96

K-4473 ExiPrep™ Dx Viral RNA Kit 96

Related Products


● Instrument - ExiStation™

Group M

LoD (IU/ml)B 33.1A

≤ 35C

CRF AGDF

≤ 40G

CRF AEH

Group ODetected

Group NFigure2. Regression analysis between AccuPower® HIV-1 Quantitative RT-PCR Kit and CE-IVD approved HIV-1 NAT assay. (R2= 0.96 (p<0.001))

Table 1. Group M subtype, group O and N LoD of AccuPower® HIV-1 Quantitative RT-PCR Kit

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HCV-1111 AccuPower® HCV Quantitative RT-PCR Kit Hepatitis C virus 96



K-4472 ExiPrep™ Dx Viral DNA Kit 96

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B-2. Hepatitis Virus AccuPower® Real-Time PCR Diagnostic Kits

Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic liver disease. Hepatitis B is transmitted through blood and infected bodily fluids. Thus, the quantification of hepatitis B virus (HBV) DNA in blood is essential for monitoring of HBV infection. The AccuPower® HBV Quantitative PCR Kit is an in vitro diagnostic kit designed for the quantification of HBV DNA in human EDTA-plasma samples through Real-Time PCR using ExiStation™ MDx System or Exicycler™ 96.

● Target - Hepatitis B virus: large S protein ● Sample type - Serum, EDTA-plasma

● Highly sensitive detection of various HBV genotypes including A, B, C, D, E, F and H (Table 1) - The LoD is 6.02 IU/ml (genotype A2) - The LoQ is 15 IU/ml ● High performance of repeatability and reproducibility (Table 2)

● High reliability through Internal Positive Control

● Specific Real-Time PCR reaction using Enzyme-mediated HotStart technology

The AccuPower® HBV Quantitative PCR Kit provides;

HBV-1111 PCR PreMix (96 rxn), SPCs (S1~S5), HPC, LPC IPC, NTC, SL buffer, DEPC D.W., Optical sealing film

Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower® HBV Quantitative PCR Kit.Black signal; HBV, Blue signal; IPC

● Instrument - ExiStation™, Exicycler™ 96

AccuPower® HBV Quantitative PCR Kit

Genotype LoD(IU/ml)

Genotype B C D E F G H

EDTA-Plasma Shown 95% detection rate below 5 IU/ml

Serum Shown 95% detection rate below 10 IU/ml

Diagnostic Sensitivity (Percent positive agreement) 100 % (95% C.I 96.71 - 100)

DiagnosticSpecificity(Percent negative agreement) 100 % (95% C.I 96.64 - 100)

Figure2. Regression analysis between AccuPower® HBV Quantitative RT-PCR Kit and CE-IVD approved HBV viral load NAT assay. (R2= 0.95 (p<0.001))

Table 1. Genotype LoD of AccuPower® HBV Quantitative RT-PCR Kit

Table 2. The performance of AccuPower® HBV Quantitative PCR Kit was compared to that of CE-IVD approved HBV viral load assay by analysis of paired EDTA plasma specimens from 224 sample in Cerba, France

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Limit of Dtection (IU/ml)

Genotype 1b 2a 2b 3 4 5 6

EDATA-plasma 5.37 11.2 17.8 13.8 13.8 18.2 15.8

Serum 8.13 12.02 22.3 12.3 12.3 22.3 25.1

Diagnostic Sensitivity (Percent positive agreement) 99.14 % (95% C.I 95.29 - 99.98)

DiagnosticSpecificity(Percent negative agreement) 99.12 % (95% C.I 95.21 - 99.98)Figure2. Regression analysis between AccuPower® HCV

Quantitative RT-PCR Kit and CE-IVD approved HCV NAT assay. (R2= 0.95 (p<0.001))

Table 1. Genotype LoD of AccuPower® HCV Quantitative PCR Kit

Table 2. The performance of AccuPower® HCV Quantitative RT-PCR Kit was compared to that of CE-IVD approved HCV NAT assay by analysis of paired EDTA plasma specimens from 230 samples in Cerba, France.


HBV-1111 AccuPower® HBV Quantitative PCR Kit Hepatitis B virus 96

HIV-1111 AccuPower® HIV-1 Quantitative RT-PCR Kit Human immunodeficiency virus type 1 96




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B-2. Hepatitis Virus AccuPower® Real-Time PCR Diagnostic Kits

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). About 80% of those exposed to the virus develop a chronic infection. Guidelines for the management and treatment of HCV recommend quantitative testing for HCV RNA before, during and after the antiviral therapy. The AccuPower® HCV Quantitative RT-PCR Kit is an in vitro diagnostic kit designed for the quantification of HCV RNA in clinical samples through Real-Time PCR using ExiStation™ MDx System.

● Target - Hepatitis C virus: 5’ UTR● Sample type - Serum, EDTA-plasma

● Clinical Evaluation (Figure 2)● Highly sensitive detection of various genotypes of HCV (genotype 1, 2,

3, 4, 5 and 6, Table 1) - The LoD is 10.7 IU/ml (genotype 1a)● Diagnostic Sensitivity and Specificity (Table 2)● One-Step Real-Time RT-PCR reaction using RocketScript™ Reverse Tran-

scriptase and Dual-HotStart™ technology

The AccuPower® HCV Quantitative RT-PCR Kit provides;

HCV-1111 PCR PreMix (96 rxn), SPCs (S1~S5), PCs (LPC and HPC), NTC, SL buffer, Optical sealing film

Figure 1. Standard Positive Controls (S1 ~ S5) of Ac-cuPower® HCV Quantitative RT-PCR Kit. Black signal; HCV, Blue signal; IPC

● Instrument - ExiStation™

AccuPower® HCV Quantitative RT-PCR Kit

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The AccuPower® BCI Blood Screening Kit is an in vitro diagnostic kit designed for the simultaneous detection of human immunodeficiency virus type 1, type 2 (HIV-1, HIV-2) RNA, hepatitis C virus (HCV) RNA and hepatitis B virus (HBV) DNA in human blood through Real-Time PCR using ExiStation™ MDx System. First, the kit is intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors. Secondly, the assay is not intended for use on cord blood specimens from mothers with recent birth. Third, the assay is intended to use individual samples from living adult donors of whole blood, blood components, plasma, other living donors and heart-beating organ donors, and from individual blood specimens from cadaveric (non-heart-beating) donors.

Figure 1. The test uses 2 wells of NTC and PC to determine the validity of the experiment, and each reaction includes IPC in wells of samples as well as NTC and PC to monitor PCR efficiency. NTC: to determine whether the sample is contaminated in the process of sample pretreatment, nucleic acid extraction, and PCR preparation (prevent false-positive error) PC: to determine whether target DNA is properly amplified (prevent false-negative error) IPC: to check whether PCR is inhibited by the sample and to determine the amplification of nucleic acids in each well. Red signal; HBV, Blue signal; HIV-1/-2, Black signal; HCV, Green signal; IPC

● Distinct detection of each target, HBV, HCV, HIV-1 and HIV-2 by ExiStation™ MDx System● High reliability through Internal Positive Control and Positive Control● One-Step Real-Time RT-PCR reaction using RocketScript™ Reverse Transcriptase and Dual-HotStart™ technology

The AccuPower® BCI Blood Screening Kit provides;


Cat. no. Kit name Tests


B-3. BCI Blood Screening AccuPower® Real-Time PCR Diagnostic Kits

● Target - Human immunodeficiency virus type 1, 2 , Hepatitis C virus, Hepatitis B virus● Sample type - Serum, EDTA-plasma ● Instrument - ExiStation™

AccuPower® BCI Blood Screening Kit

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● Multiplex detection of TB and MDR-TB● Simplified procedure of sputum pretreatment with EZ Solution ● Highly sensitive detection of TB and MDR-TB - The LoD determined that the concentration of TB DNA detected with 95% probability is 3.98 copies/test for RIF - The LoD of TB is 179.8 copies/test for INH and 21.88 copies/test for TB

The AccuPower® TB&MDR Real-Time PCR Kit provides;

Figure 1. Multidrug-resistance detection method: Allele-Specific PCR Figure 2. Example of TB and MDR-TB detection


MTN-1111 AccuPower® MTB&NTM Real-Time PCR Kit Mycobacterium tuberculosis, Non-tuberculous mycobacteria 96

MTB-1111 AccuPower® MTB Real-Time PCR Kit Mycobacterium tuberculosis 96

NTM-1111 AccuPower® NTM Real-Time PCR Kit Non-tuberculous mycobacteria 96


K-4418 ExiPrep™ Dx Mycobacteria Genomic DNA Kit 96

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B-4. Mycobacterium Tuberculosis AccuPower® Real-Time PCR Diagnostic Kits

● Target - * RIF : rpoB (codon 509, 511, 516, 522, 526, 531, 533), 10 mutant sites, 29 mutations * TB&INH : IS6110(MTB), katG315, inhA (INH) 3 mutant sites, 7 mutations ● Sample type - Sputum, Bronchoalveolar lavage (BAL), Urine

● Instrument - ExiStation™, Exicycler™ 96

Multidrug-resistant tuberculosis (MDR-TB) is caused by an organism that is resistant to the two most potent TB drugs: isoniazid (INH) and rifampicin (RIF). These drugs are used to treat all persons with TB disease. However, spontaneous mutations in the Mycobacterium tuberculosis genome can give rise to proteins that make the bacterium drug resistant, depending on the type of drug action. With this, almost 2~3% of new TB patients have MDR-TB, where an effective treatment of TB and MDR-TB, early detection is the top priority. AccuPower® TB & MDR Real-Time PCR Kit is an in vitro diagnostic kit designed for the simultaneous detection of M. tuberculosis and MDR-TB DNA extracted from clinical samples. Detectable MDR-TBs are INH and RIF resistant TB.

TBMDR-1111 PCR premix (48rxn), TB&MDR PC, IPC, NTC, DEPC D.W., Optical sealing film

AccuPower® TB&MDR Real-Time PCR Kit

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MTB-1111 AccuPower® MTB Real-Time PCR Kit Mycobacterium tuberculosis 96

NTM-1111 AccuPower® NTM Real-Time PCR Kit Non-tuberculous mycobacteria 96

TBMDR-1111 AccuPower® TB&MDR Real-Time PCR Kit Mycobacterium tuberculosis, Multidrug-resistant tuberculosis (Rifampicin, Isoniazid) 48


K-4414 ExiPrep™ Dx Bacteria Genomic DNA Kit 96


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B-4. Mycobacterium Tuberculosis AccuPower® Real-Time PCR Diagnostic Kits

● Target - Mycobacterium tuberculosis: IS6110, Non-tuberculous mycobacteria: rpoB ● Sample type - Sputum, BAL, Urine● Instrument - ExiStation™, Exicycler™ 96

Tuberculosis (TB) is caused by a bacterium called M. tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain. It can affect mainly the lungs (pulmonary TB). Non-tuberculous mycobacteria (NTM) are a group of bacteria, normally found in soil and water and some domestic and wild animals that can cause severe lung disease. The AccuPower® MTB&NTM Real-Time PCR Kit is an in vitro diagnostic kit designed for the simultaneous detection of M. tuberculosis and NTM DNA in clinical samples through Real-Time PCR using ExiStation™ MDx System or Exicycler™ 96. MTN-1111 PCR premix (96rxn), MTB&NTM PC, IPC, NTC,

DEPC D.W., Optical sealing film

AccuPower® MTB&NTM Real-Time PCR Kit

● Highly sensitive detection of TB - The LoD of TB (M. tuberculosis, ATCC 25177) is 20.4 copies/test● A broad range of detection of 57 NTM species including the most common 8 species listed below - The LoD of M. avium is 44.7 copies/test - The LoD of M. intracellulare is 158.5 copies/test - The LoD of M. abscessus is 72.4 copies/test - The LoD of M. chelonae is 52.5 copies/test - The LoD of M. kansasii is 190.5 copies/test - The LoD of M. fortuitum is 53.7 copies/test - The LoD of M. gordonae is 109.6 copies/test - The LoD of M. massiliense is 57.5 copies/test

The AccuPower® MTB&NTM Real-Time PCR Kit provides;

Figure 1. Detection of TB and NTM Positive Control using Exicycler™ 96. Black signal; MTB, Red signal; NTM, Blue signal; IPC

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Sexually Transmitted Infection (STI) is an infection that can be transferred from one person to another by means of sexual contact, including oral sex, anal sex, and sharing sex toys. Chlamydia infection is a common sexually transmitted infection in human caused by the bacterium Chlamydia trachomatis. Neisseria gonorrhoeae is pathogenic to humans who are its only natural host, and it is responsible for the disease Gonorrhea. Symptoms of infection with N. gonorrhoeae differ, depending on the site of infection. Ureaplasma urealyticum is part of the normal genital flora of both men and women. It is found in about 70% of sexually active humans. Mycoplasma genitalium is an emerging sexually transmitted pathogen implicated in urethritis in men and several inflammatory reproductive tract syndromes in women. Depending on the disease, some untreated STIs can lead to infertility, chronic pain or even death. Early identification and treatment results in less chance to spread disease and for some conditions may improve the outcomes of treatment.


STI8B-1111 AccuPower® STI8B-Plex Real-Time PCR Kit Trichomonas vaginalis, Mycoplasma hominis, Herpes simplex virus type 1&2

96

CHT-1111 AccuPower® CT Real-Time PCR Kit Chlamydia trachomatis 96

NSG-1111 AccuPower® NG Real-Time PCR Kit Neisseria gonorrhoeae 96

STD2A-1211 AccuPower® CT&NG Real-Time PCR Kit Chlamydia trachomatis, Neisseria gonorrhoeae 96

UUU-1111 AccuPower® UU Real-Time PCR Kit Ureaplasma urealyticum 96

MPG-1111 AccuPower® MG Real-Time PCR Kit Mycoplasma genitalium 96

CANGV-1111 AccuPower® CA&GV Real-Time PCR Kit Candida albicans, Gardnerella vaginlais 96



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B-5. Sexually Transmitted Infections AccuPower® Real-Time PCR Diagnostic Kits

● Target - Chlamydia trachomatis: ompA , Neisseria gonorrhoeae: 16s rRNA, Ureaplasma urealyticum: ureC, Mycoplasma genitalium: mgpA ● Sample type - Male urine, Female vaginal swab● Instrument - ExiStation™

STI8A-1111 PCR Premix (96rxn), STI8A PC, IPC, NTC, DEPC D.W., Optical sealing film

AccuPower® STI8A-Plex Real-Time PCR Kit 0197

● Highly sensitive detection of STI pathogens - The LoD of C. trachomatis is 8.91 copies/test - The LoD of N. gonorrhoeae is 11.75 copies/test - The LoD of U. urealyticum is 33.88 copies/test - The LoD of M. genitalium is 10.20 copies/test

● Simultaneous detection of 8 STI pathogens with STI8B-Plex Real-Time PCR Kit using ExiStation™ MDx System

● High reliability through Internal Positive Control, Positive Control and No Template Control

The AccuPower® STI8A-Plex Real-Time PCR Kit provides;

Figure 1. Detection of STI8A-Plex Positive Control using Exicycler™ 96. Black signal; CT, Red signal; NG, Purple signal; UU, Green signal; MG, Blue signal; IPC

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STI8A-1111 AccuPower® STI8A-Plex Real-Time PCR Kit Chlamydia trachomatis, Neisseria gonorrhoeae, Ureaplasma urealyticum, Mycoplasma genitalium 96

TVG-1111 AccuPower® TV Real-Time PCR Kit Trichomonas vaginalis 96

MPH-1111 AccuPower® MH Real-Time PCR Kit Mycoplasma hominis 96

HSM-1111 AccuPower® HSV Type 1&2 Real-Time PCR Kit Herpes simplex virus type 1&2 96

HV6-1111 AccuPower® HHV6 Real-Time PCR Kit Human herpes virus 6 96

HV8-1111 AccuPower® HHV8 Real-Time PCR Kit Human herpes virus 8 96

TGN-1111 AccuPower® TG Real-Time PCR Kit Toxoplasma gondii 96



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● Target - Trichomonas vaginalis: β-tubulin, Mycoplasma hominis: Gap, Herpes simplex virus 1: us4, Herpes simplex virus 2: gG ● Sample type - Urine, Vaginal swab, Urethral swab● Instrument - ExiStation™, Exicycler™ 96

● Highly sensitive detection of STI pathogens - The LoD of T. vaginalis is 32.36 copies/test - The LoD of M. hominis is 47.86 copies/test - The LoD of HSV 1 is 30.20 copies/test - The LoD of HSV 2 is 48.98 copies/test

● Simultaneous detection of 8 STI pathogens with STI8A-Plex Real- Time PCR Kit using ExiStation™ MDx System


The AccuPower® STI8B-Plex Real-Time PCR Kit provides;

Figure 1. Detection of STI8B-Plex Positive Control using Exicycler™ 96. Black signal; TV, Red signal; HSV 1, Purple signal; HSV 2, Green signal; MH, Blue signal; IPC

Trichomoniasis is one of the most common STIs caused by a small organism called Trichomonas vaginalis. Women are most often affected by this disease, although men can become infected and pass the infection to their partners through sexual contact. Mycoplasma hominis is a strain of bacteria that is present in the urogenital area. Infection is usually asymptomatic, but for pregnant women, infection can lead to premature birth. Herpes simplex type 1, which is transmitted through oral secretions or sores on the skin, can be spread through kissing or sharing objects such as toothbrushes or eating utensils. In general, a person can only get herpes type 2 infections during sexual contact with someone who has a genital HSV-2 infection. Depending on the disease, some untreated STIs can lead to infertility, chronic pain or even death. Early identification and treatment results in less chance to spread disease and for some conditions may improve the outcomes of treatment.

STI8B-1111 PCR premix (96rxn), STI8B PC, IPC, NTC, DEPC D.W., Optical sealing film

AccuPower® STI8B-Plex Real-Time PCR Kit

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STI8B-1111 AccuPower® STI8B-Plex Real-Time PCR Kit Trichomonas vaginalis, Mycoplasma hominis, Herpes simplex virus type 1&2 96

CHT-1111 AccuPower® CT Real-Time PCR Kit Chlamydia trachomatis 96







Related Products


● Target - Chlamydia trachomatis : ompA, cryptic plasmid, Neisseria gonorrhoeae: porA ● Sample type - Male urine, Female vaginal swab● Instrument - ExiStation™

● Highly sensitive detection of C. trachomatis and N. gonorrhoeae - The LoD of C. trachomatis is 9.12 copies/test - The LoD of N. gonorrhoeae is 8.71 copies/test● High reliability through Internal Positive Control, Positive Control and No Template Control

The AccuPower® CT&NG Real-Time PCR Kit provides

Figure 1. Detection of CT & NG Positive Control using Exicycler™ 96. Black signal; CT, Red signal; NG, Blue signal; IPC

C. trachomatis and N. gonorrhoeae are two of the most prevalent sexually transmitted pathogens, with high rates of infection among female commercial sex workers in developing countries, a substantial proportion of whom have asymptomatic infections. C. trachomatis causes cervicitis, urethritis, salpingitis, proctitis and endometritis in women and urethritis, epididymitis and proctitis in men. Acute infections are reported more frequently in men because women often have no symptoms of infection. N. gonorrhoeae causes acute urethritis in males, which if untreated can develop into epididymitis, prostatitis, and urethral stricture. In females, the primary site of infection is the endocervix. An important complication in females is development of pelvic inflammatory disease which contributes to infertility. The AccuPower® CT&NG Real-Time PCR Kit is an in vitro diagnostic kit designed for the simultaneous detection of C. trachomatis and N. gonorrhoeae DNA in clinical samples through Real-Time PCR using ExiStation™ MDx System or Exicycler™ 96.

STD2A-1211 PCR Premix (96rxn), CT&NG PC, IPC, NTC, DEPC D.W., Optical sealing film

AccuPower® CT&NG Real-Time PCR Kit 0197

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STI8B-1111 AccuPower® STI8B-Plex Real-Time PCR Kit Trichomonas vaginalis, Mycoplasma hominis, Herpes simplex virus type 1&2 96

STD2A-1211 AccuPower® CT&NG Real-Time PCR Kit Chlamydia trachomatis, Neisseria gonorrhoeae 96







Related Products


● Target - Chlamydia trachomatis: ompA ● Sample type - Male urine, Female vaginal swab● Instrument - ExiStation™

● Highly sensitive detection of C. trachomatis - The LoD is 6.16 copies/test


The AccuPower® CT Real-Time PCR Kit provides

Figure 1. Detection of CT Positive Control using Exicycler™ 96. Black signal; CT, Blue signal; IPC

C. trachomatis is the most common curable sexually transmitted infection. Approximately 5-10% of sexually active women under 24 and men between 20-24 may be currently infected. Even though symptoms of chlamydia are usually mild or absent, serious complications that cause irreversible damage, including infertility. Chlamydia can occur “silently” before a woman ever recognizes a problem. Chlamydia can also cause discharge from the penis of an infected man. Chlamydia can be transmitted during vaginal, anal, or oral sex. Chlamydia can also be passed from an infected mother to her baby during vaginal childbirth. The AccuPower® CT Real-Time PCR Kit is an in vitro diagnostic kit designed for the detection of C. trachomatis DNA in clinical samples through Real-Time PCR using ExiStation™ MDx System or Exicycler™ 96.

CHT-1111 PCR Premix (96rxn), CT PC, IPC, NTC, DEPC D.W., Optical sealing film

AccuPower® CT Real-Time PCR Kit 0197

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EBV-1111 AccuPower® EBV Quantitative PCR Kit Epstein-Barr virus 96

BKV-1111 AccuPower® BKV Quantitative PCR Kit BK virus 96




K-4474 ExiPrep™ Dx Blood Viral DNA Kit 96

Related Products

B-6. Transplantation related Virus AccuPower® Real-Time PCR Diagnostic Kits

● Target - Human Cytomegalovirus: glycoprotein B (gB) ● Sample type - Whole blood, EDTA-plasma● Instrument - ExiStation™, Exicycler™ 96

● Highly sensitive detection of human cytomegalovirus (Table 1) - The LoD is 66 IU/ml (400 ul EDTA-plasma) - The LoQ is 100 IU/ml (400 ul EDTA-plasma)● Simplified procedure by eliminating clinical sample pretreatment step - Whole blood, urine and breast milk samples can be directly used for the quantification of CMV viral load using ExiStation™ MDx System

● Specific Real-Time PCR reaction by Dual-HotStart™ technology

The AccuPower® CMV Quantitative PCR Kit provides;

Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower® CMV Quantitative PCR Kit .Black signal; CMV, Blue signal; IPC

Human cytomegalovirus (HCMV) infection is acquired subclinically during childhood. It is usually transmitted via body fluid, blood, solid organ transplant and stem cell transplant recipients. Thus, monitoring of CMV viral load is essential for newborns and transplant recipients. The AccuPower® CMV Quantitative PCR Kit is an in vitro diagnostic kit designed for the quantification of CMV DNA in clinical samples through Real-Time PCR using ExiStation™ MDx System or Exicycler™ 96.

CMV-1111 PCR premix (96rxn), SPCs (S1~S5), IPC, NTC, DEPC D.W., SL buffer, Optical sealing film

AccuPower® CMV Quantitative PCR Kit

Sample type LoD (IU/ml) LoQ (IU/ml) Quantitative Range (IU/ml)

EDTA-plasma 66 100 102 ~ 2x107

Whole blood 117 240 240 ~ 6x107

Table 1. Performance of AccuPower® CMV Quantitative PCR Kit

Table 1. Performance of AccuPower® EBV Quantitative PCR Kit

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CMV-1111 AccuPower® CMV Quantitative PCR Kit Human cytomegalovirus 96

BKV-1111 AccuPower® BKV Quantitative PCR Kit BK virus 96




K-4474 ExiPrep™ Dx Blood Viral DNA Kit 96

Related Products


● Target - Epstein-Barr virus (EBV) : glycoprotein ● Sample type - Whole blood, EDTA-plasma● Instrument - ExiStation™, Exicycler™ 96

● Highly sensitive detection of Epstein-Barr virus (Table 1) - The LoD is 79 IU/ml (400 ul EDTA-plasma) - The LoQ is 100 IU/ml (400 ul EDTA-plasma)

● Simplified procedure by eliminating clinical sample pretreatment step - Whole blood and EDTA-plasma samples can be directly used for the quantification of EBV viral load using ExiStation™ MDx System

● Specific Real-Time PCR reaction by Dual-HotStart™ technology

The AccuPower® EBV Quantitative PCR Kit provides;

Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower® EBV Quantitative PCR Kit.Black signal; EBV, Blue signal; IPC

Epstein-Barr virus (EBV) or HHV-4 is a ubiquitous virus that infects humans worldwide. EBV is associated with a spectrum of clinical presentations on transplant recipients, from fever to post-transplantation lymphoproliferative disorder (PTLD). Increasing EBV viral loads have been demonstrated to correlate with the development of EBV related diseases and quantitative PCR is considered a valuable tool to monitor patients with high risk of PTLD. The AccuPower® EBV Quantitative PCR Kit is an in vitro diagnostic kit designed for the quantification of EBV DNA in human whole blood and EDTA-plasma samples through Real-Time PCR using ExiStation™ MDx System or Exicycler™ 96.

EBV-1111 PCR premix (96rxn), SPCs (S1~S5), LPC,HPC, IPC, NTC, DEPC D.W., SL buffer, Optical sealing film

Sample type LoD (IU/ml) LoQ (IU/ml) Quantitative Range (IU/ml)

EDTA-plasma 79 100 102 ~ 2.5x108

Serum 83 150 150 ~ 108

Whole blood 117 200 200 ~ 107

Table 1. Performance of AccuPower® EBV Quantitative PCR Kit

AccuPower® EBV Quantitative PCR Kit

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CMV-1111 AccuPower® CMV Quantitative PCR Kit Human cytomegalovirus 96

EBV-1111 AccuPower® EBV Quantitative PCR Kit Epstein-Barr virus 96




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● Target - BK virus (BKV) : Small T antigen● Sample type - Serum, Urine● Instrument - ExiStation™, Exicycler™ 96

● Highly sensitive detection of BK virus (Table 1) - The LoD is 78 copies/ml (400 ul serum) - The LoQ is 150 copies/ml (400 ul serum)

● Simplified procedure by eliminating clinical sample pretreatment step - Serum and urine samples can be directly used for the quantification of BKV viral load using ExiStation™ MDx System● High performance of repeatability and reproducibility (Table 2)

The AccuPower® BKV Quantitative PCR Kit provides;

Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower® BKV Quantitative PCR Kit.Black signal; BKV, Blue signal; IPC

BK virus (BKV) was originally discovered and isolated from the urine of a renal allograft recipient. The source of BKV infection is due to decline in immunologic activity from either graft dysfunction and graft rejection in renal transplant recipients under immunosuppressed state. The AccuPower® BKV Quantitative PCR Kit is an in vitro diagnostic kit designed for the quantification of BKV DNA in urine and serum samples through Real-Time PCR using ExiStation™ MDx System or Exicycler™ 96.

BKV-1111 PCR premix (96rxn), SPCs(S1~S5), IPC, NTC, DEPC D.W., SL buffer, Optical sealing film

AccuPower® BKV Quantitative PCR Kit

Conc. (copies/ml)

Within-run Between-day Between-batch

SD (copies/ml)

SD (copies/ml)

SD (copies/ml)

103 0.35 0.39 0.18

105 0.44 0.32 0.30

107 0.42 0.36 0.25

Sample type

LoD (copies/ml)

LoQ (copies/ml)

Quantitative Range (copies/ml)

Serum 78 150 150-107

Table 1. Performance of The AccuPower® BKV Quantitative PCR KitTable 2. Repeatability and reproducibility of AccuPower® BKV Quantitative PCR Kit

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HPG-1111 AccuPower® HPV Genotyping Kit Human Papillomavirus 27genotypes 12




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B-7. Human Papillomavirus AccuPower® Real-Time PCR Diagnostic Kits

● Target - Human Papillomavirus type 16, Human Papillomavirus type 18 ● Sample type - Cervical swab● Instrument - ExiStation™, Exicycler™ 96

● Highly sensitive detection of HPV type 16 and 18 - The LoD of HPV type 16 is 13.18 copies/test - The LoD of HPV type 18 is 10.18 copies/test

● High reliability through Internal Positive Control and Positive Control (Figure 1)

● Simultaneous detection of high risk HPV type 16 and 18

● Specific Real-Time PCR reaction using Enzyme-mediated HotStart technology

The AccuPower® HPV 16&18 Real-Time PCR Kit provides;

Figure 1. Detection of HPV 16&18 Positive Control using Exicycler™ 96. Black signal; HPV16, Red signal; HPV18, Blue signal; IPC

The global incidence and death from cervical cancer rank the second and third highest respectively among women. The main cause of cervical cancer is Human papillomavirus (HPV) in the cervix. According to the study with 196 patients in cervical adenocarcinoma, HPV genotype 18 is responsible for cervical cancer in 54.2% of the patients; HPV 16, in 44.1%. The AccuPower® HPV 16&18 Real-Time PCR Kit is an in vitro diagnostic kit designed for the simultaneous detection of HPV type 16 and 18 DNA in human cervical swab samples through Real-Time PCR. The kit is configured for use with ExiStation™ MDx System or Exicycler™ 96. HPM-1111 PCR premix (96rxn), PC, IPC, DEPC D.W.,

Optical sealing film

Table 1. Comparison of Bioneer HPV16&18 kit with Reference method

AccuPower® HPV 16&18 Real-Time PCR Kit

The clinical evaluation of the AccuPower® HPV 16&18 Real-Time PCR Kit was performed on 22 clinical samples. Out of 22 samples, the AccuPower® HPV16&18 Real-Time PCR Kit determined four specimens as HPV16-positive, another four as HPV18-positive, another four as HPV16 and 18-positive, the rest ten as negative. Those results agreed 100% with those from direct sequencing results (Table 1).

Diagnostic Evaluation and Correlation with Reference Method

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HPM-1111 AccuPower® HPV 16&18 Real-Time PCR Kit Human Papillomavirus 16 & 18 96




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B-7. Human Papillomavirus AccuPower® Real-Time PCR Diagnostic Kits

● Target - Human Papillomavirus 27 genotypes (Table 1)● Sample type - Cervical swab, Vaginal swab ● Instrument - Exicycler™ 96

● Simultaneous detection of 19 high risk HPV genotypes and 8 low risk HPV genotypes

● Highly sensitive detection of HPV genotypes (Table 1) ● Specific Real-Time PCR reaction using Enzyme-mediated HotStart

technology● Compliance with CE-IVD / MFDS

The AccuPower® HPV Genotyping Kit provides;

The global incidence and death from cervical cancer rank the second and third highest respectively among women. The main cause of cervical cancer is Human papillomavirus (HPV) in the cervix. There are over 100 different types of HPV. HPV types are often referred to as ‘low-risk’ or ‘high-risk’, based on whether they put a person at risk for cervical cancer. The AccuPower® HPV Genotyping Kit is an in vitro diagnostic kit designed for the simultaneous detection of 27 HPV genotypes in human cervical or vaginal swab samples through Real-Time PCR. The kit is configured for use with Exicycler™ 96. HPG-1111 PCR premix (12rxn), PC, DEPC D.W., Optical

sealing film

AccuPower® HPV Genotyping Kit

Figure 1. Clinical sample test results of AccuPower® HPV Genotyping Kit (flu. graph)

Sample No. DNA chip assay Bioneer result

1 16 16

2 Others 53

3 54 54

4 Others 33

5 Negative Negative

Table 2. Evaluation results of AccuPower® HPV Genotyping Kit. & DNA chip assay using clinical samples

HPV High Risk HPV Low Risk

Genotype LoD Genotype LoD Genotype LoD

16 13.8 53 25.7 6 6.45

18 12.58 56 14.7 11 13.1

26 12.3 58 10.4 40 7.41

31 14.4 59 33.1 42 4.17

33 5.62 66 5.01 43 5.89

35 5.75 68 3.72 44 7.94

39 23.9 69 4.79 54 5.75

45 14.4 73 4.79 70 3.31

51 28.1 82 24.5

52 4.79

Table 1. The LoD of AccuPower® HPV Genotype Kit (copy/test)

The clinical evaluation of the AccuPower® HPV Genotyping Kit was performed on 5 clinical samples. AccuPower® HPV Genotyping Kit provided more sensitive results than DNA chip assay. (Figure 1, Table 2)

Diagnostic Evaluation with Reference Method

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● Highly sensitive detection of influenza A and new influenza A (H1N1-2009)- The LoD of new influenza A (H1N1-2009) is 120.2 copies/ml- The LoD of influenza A is 275.4 copies/ml

● High reliability through Internal Positive Control and Positive Control● One-Step Real-Time RT-PCR reaction using RocketScript™ Reverse Transcriptase and Dual-HotStart™ technology

The AccuPower® New InfA (H1N1) & InfA Real-Time RT-PCR Kit provides;

Figure 1. Detection of new Influenza A (H1N1) Positive Control using Exicycler™ 96. Black signal; new InfA(H1N1), Blue signal; IPC

Figure 2. Detection of Influenza A Positive Control using Exicycler™ 96.Black signal; InfA, Blue signal; IPC

Related Products


IFA-1111 AccuPower® Influenza A Real-Time RT-PCR Kit Influenza A 96

SIV-1111 AccuPower® New InfA (H1N1) Real-Time RT-PCR Kit New Influenza A (H1N1) 96




B-8. Respiratory Pathogens AccuPower® Real-Time PCR Diagnostic Kits

● Target - New Influenza A (H1N1) : HA gene, Influenza A : matrix protein gene

● Sample type - Nasopharyngeal swab, BAL● Instrument - Exicycler™ 96

Influenza occurs all over the world, with an annual global attack rate estimated at 5–10% in adults and 20–30% in children. In temperate regions, influenza is a seasonal disease occurring typically in winter months. The subtypes of influenza A viruses are determined by envelope glycoproteins possessing either haemagglutinin (HA) or neuraminidase (NA) activity. Influenza A (H1N1) virus emerged in 2009 is a new reassortment that has never before circulated among humans. This virus is not closely related to previous or current human seasonal influenza viruses. The AccuPower® New InfA (H1N1) & InfA Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for the detection of influenza A (H1N1-2009, common) virus RNA in clinical samples through Real-Time PCR using Exicycler™ 96.

SIA-1111 New InfA(H1N1) PCR premix (48rxn), Influenza A PCR Premix (48rxn), PC, IPC, DEPC D.W., Optical sealing film

AccuPower® New InfA (H1N1) & InfA Real-Time RT-PCR Kit

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Chlamydia pneumoniae is a species of Chlamydophila, an obligate intracellular bacterium that infects humans and is a major cause of pneumonia. Outbreaks of C. pneumoniae occur mostly in crowded environments, like schools, college dormitories, military barracks, and nursing homes, where transmission is possible through airborne droplets from close person-to-person contact. C. pneumoniae causes mild pneumonia or bronchitis in adolescents and young adults. Older adults may experience more severe disease and repeated infections. The AccuPower® CP Real-Time PCR Kit is an in vitro diagnostic kit designed for the detection of C. pneumonia DNA in clinical samples through Real-Time PCR using ExiStation™ MDx System or Exicycler™ 96.

● Highly sensitive detection of C. pneumoniae - The LoD is 60.3 copies/ml

● Simplified procedure of sputum pretreatment with EZ Solution

● Low coefficient of variation (CV) for between-day precision and inter-instrument trueness within 1.74 %● No interference observed in the presence of the interfering substances

such as blood and hemoglobin

The AccuPower® CP Real-Time PCR Kit provides;

Figure 1. Detection of CP Positive Control using Exicycler™ 96.Black signal; CP, Blue signal; IPC


MPN-1111 AccuPower® MP Real-Time PCR Kit Mycoplasma pneumoniae 96




Related Products

● Target - Chlamydia pneumoniae: LKK-1 outer membrane protein A● Sample type - Sputum, BAL● Instrument - ExiStation™, Exicycler™ 96

AccuPower® CP Real-Time PCR Kit


CPN-1111 PCR premix (96rxn), PC, IPC, NTC, DEPC D.W., Optical sealing film

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AccuPower® MP Real-Time PCR Kit


MPN-1111 PCR premix (96rxn), PC, IPC, NTC, DEPC D.W., Optical sealing film

Mycoplasma pneumonia is a form of atypical bacterial pneumonia caused by the bacterial species Mycoplasma pneumoniae. In general, M. pneumoniae infection is a mild illness that is most common in young adults and school-aged children. The most common type of illness, that is caused by the bacteria, especially in children, is tracheobronchitis, commonly called a chest cold. Diagnosis of M. pneumoniae infections is complicated by the delayed onset of symptoms and the similarity of symptoms to other pulmonary conditions. Among other diagnostic tools, PCR is the most rapid and effective way to determine the presence of M. pneumoniae. The AccuPower® MP Real-Time PCR Kit is an in vitro diagnostic kit designed for the detection of M. pneumonia DNA in sputum, BAL and throat swab samples through Real-Time PCR using ExiStation™ MDx System or Exicycler™ 96.

● Highly sensitive detection of M. pneumoniae - The LoD is 281.8 copies/ml

● Simplified procedure of sputum pretreatment with EZ Solution

● Low coefficient of variation (CV) for between-day precision and inter- instrument trueness within 1.89 %

● No interference observed in the presence of the interfering substances such as blood and hemoglobin

The AccuPower® MP Real-Time PCR Kit provides;

Figure 1. Detection of MP Positive Control using Exicycler™96.Black signal; MP, Blue signal; IPC


CPN-1111 AccuPower® CP Real-Time PCR Kit Chlamydia pneumoniae 96




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● Target - Mycoplasma pneumoniae : cytohesin P1● Sample type - Sputum, BAL● Instrument - ExiStation™, Exicycler™ 96

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AccuPower® MERS-CoV (upE&ORF1a) Real-Time PCR Kit


COV-1112 PCR premix (48rxn), PC, IPC, NTC, DEPC D.W.,Optical sealing film

Middle East respiratory syndrome (MERS) is a viral respiratory illness caused by a coronavirus called MERS-CoV. It was first reported in Saudi Arabia in 2012 and has spread to other countries including South Korea. Camels and bats are suspected to be the primary source of the infection for humans. MERS causes high fever, cough, and severe shortness of breath, and can also leads up to kidney failure and even death in patients who had a history of other medical conditions. There are currently no vaccines for MERS and no treatments available to cure the infection. The AccuPower® MERS-CoV Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for the detection of MERS-CoV upstream of E gene (upE) and Open reading frame 1a (ORF1a) gene in human sputum, nasopharyngeal swab and bronchial alveolar lavage (BAL) through real-time polymerase chain reaction (PCR) using ExiStation™ MDx System or Exicycler™ 96.

● Highly sensitive detection of MERS-CoV - The upE LoD is 56.23 copies/ml - The ORF1a LoD is 79.43 copies/ml

● High reliability through IPC, PC and NTC● Specific one-step Real-Time RT-PCR reaction using Dual-HotStart™ technology

The AccuPower® MERS-CoV (upE&ORF1a) Real-Time PCR Kit provides;

Figure 1. Detection of MERS-CoV (upE) Positive Control using Exicycler™ 96.Black signal; MERS-CoV(upE), Blue signal; IPC

Figure 2. Detection of MERS-CoV (ORF1a) Positive Control using Exicycler™ 96Green signal; MERS-CoV(ORF1a), Blue signal; IPC


COV-1111 AccuPower® MERS-CoV Real-Time RT-PCR Kit MERS-CoV (upE) 96



Related Products

● Target - upE, ORF1a● Sample type - Sputum, Nasopharyngeal swab, Bronchoalveolar lavage (BAL)● Instrument - ExiStation™, Exicycler™ 96

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B-9. Gastrointestinal Pathogens AccuPower® Real-Time PCR Diagnostic Kits

AccuPower® Norovirus Real-Time RT-PCR Kit

NOR-1111/1112 PCR premix (96rxn), PC, IPC, NTC, DEPC D.W., Optical sealing film

Norovirus is an RNA virus of the Caliciviridae family and infects people regardless of age and infection occurs sporadically throughout the world. The potential for norovirus infection can occur in food poisoning even with very low virus numbers, and transmission through bodily fluids. The AccuPower® Norovirus Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for the detection of norovirus GI/GII RNA in human stool or rectal swab samples through Real-Time PCR using Exicycler™ 96 or ABI systems.

● Target - Norovirus GI, GII: , Norovirus Open Reading Frame (ORF) 2 and 3● Sample type - Stool, Rectal swab● Instrument - Exicycler™ 96, ABI 7300/7500/7500 Fast

Figure 1. Detection of Norovirus Positive Control using Exicycler™ 96. Red signal; GI, Black signal; GII, Blue signal; IPC

● Highly sensitive detection of various subtypes of norovirus (GI:1 to 9, GII:1 to 22)

- The LoD of GI is 1,264 copies/ml- The LoD of GII is 696 copies/ml

● Multiplex detection of norovirus GI and GII in one tube

● Specific one-step Real-Time RT-PCR reaction using Dual-HotStart™ technology

The AccuPower® Norovirus Real-Time RT-PCR Kit provides;

Related ProductsCat. no. Kit name Instrument Tests

NOR-1111 AccuPower® Norovirus Real-Time RT-PCR Kit Exicycler™ 96 96

NOR-1112F AccuPower® Norovirus Real-Time RT-PCR Kit ABI 7500 Fast system 96

NOR-1112S AccuPower® Norovirus Real-Time RT-PCR Kit ABI 7300, 7500 96




RIDASCREEN ELISA

RIDAGENE Real-Time PCR kit

AccuPowerReal-Time PCR kit

No. of specimen(%)

Positive Positive Positive 91 (32.4%) Positive Positive Negative 0 (0.0%) Positive Negative Positive 2 (0.7%) Positive Negative Negative 16 (5.7%) Negative Positive Positive 5 (1.8%) Negative Positive Negative 1 (0.4%) Negative Negative Positive 7 (2.5%) Negative Negative Negative 159 (56.6%) Total 281 (100%)

R

Tabel 1. Comparison of the results Percent positive agreement of AccuPower® PCR kit compared to RIDAGENE PCR kit: 99.0% (96/97) (95% CI, 94.4–100%). Percent negative agreement of AccuPower® PCR kit compared to RIDAGENE PCR kit: 95.1% (175/184) (95% CI, 90.9–97.7%). Among 10 specimen (3.6%) with discordant results between the 2 Real-Time PCR, 7 specimen were confirmed norovirus GII positive by direct sequencing which results were in agreement with AccuPower® PCR kit results.

Genotype No. of samples No. of detected by AccuPower Real-Time PCR kit

Detection rate

GL1 1 1 100% GL3 1 1 100% GIL3 14 14 100% GIL4 72 72 100% GIL6 1 1 100% GIL12 3 3 100% GIL untyped or no

sample for genotyping 113 13

RIDAGENE PCR positive, no sample for genotyping

1 0

Total 106 105 99.1%

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Table 2. Detectability of norovirus genotypes by AccuPower® Real-Time PCR kits *J. Hyun et al. / Diagnostic Microbiology and Infectious Disease 78(2014) 40–44

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B-9. Gastrointestinal Pathogens AccuPower® Real-Time PCR Diagnostic Kits

AccuPower® Enterovirus 71 Real-Time RT-PCR Kit E71-1111

AccuPower® EV Real-Time RT-PCR Kit

ENT-1111 PCR premix (96rxn), PC, IPC, NTC, DEPC D.W., Optical sealing film

Enterovirus can be classified into one of five major groups, including polioviruses, echoviruses, coxsackieviruses A, coxsackieviruses B and other enteroviruses. Infected persons who become ill usually develop mild upper respiratory symptoms (a “cold”), a flu-like illness with fever and muscle aches, or an illness with rash. Rarely, a person may develop an illness that affects the heart (myocarditis) or the brain (encephalitis) or causes paralysis. The AccuPower® EV Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for the detection of enterovirus RNA in human stool or cerebrospinal fluid (CSF) samples through Real-Time PCR using Exicycler™ 96.

● Target - Enterovirus: 5’UTR● Sample type - Stool, Cerebrospinal fluid (CSF)● Instrument - Exicycler™ 96

● Highly sensitive detection of various enterovirus serotypes (Table 1)- The LoD is 309 copies/ml

● Specific one-step Real-Time RT-PCR reaction using Dual-HotStart TM

technology

Table1. Detectable Enterovirus SerotypesDetectable serotype

Enterovirus 71, 76, 77, 79, 80, 82, 83, 87, 97, 101, B, yanbian96-83Coxackievirus A A2, A3, A4, A5, A6, A8, A9, A10, A12, A14, A15, A16, A18, A20, A24Coxackievirus B B1, B2, B3, B4, B5

Echovirus 3, 4, 6, 7, 9, 11, 13, 14, 16, 17, 18, 21, 24, 25, 30, 32, 33Poliovirus 1, 2, 3

Total 52 serotypes

The AccuPower® EV Real-Time RT-PCR Kit provides;

Figure 1. Detection of Enterovirus Positive Control using Exicycler™ 96. Black signal; Enterovirus, Blue signal; IPC

Enterovirus 71 (EV71) is one of a large family of viruses which multiply in the human gastrointestinal tract (gut). The EV71 infection may be asymptomatic or it may cause diarrhea, rashes, and hand, foot and mouth disease (HFMD). Furthermore, EV71 infections can also cause neurological and systemic complications such as aseptic meningitis, acute flaccid paralysis, and encephalitis (usually in the brainstem). Children under 5 years old, especially those under 2 years, are at higher risk of developing a severe EV71 infection. The AccuPower® Enterovirus 71 Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for the detection of enterovirus 71 RNA in clinical samples through Real-Time PCR using Exicycler™ 96.

● Target - Enterovirus 71: VP1● Sample type - Stool, Cerebrospinal fluid (CSF)● Instrument -Exicycler™ 96

● Highly sensitive detection of Enterovirus 71 - The LoD is 263.03 copies/ml● Specific one-step Real-Time RT-PCR reaction using Dual-HotStart™ technology

The AccuPower® Enterovirus 71 Real-Time RT-PCR Kit provides;

Related ProductsNucleic Acid Extraction Kit using with ExiPrep™16 Dx




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B-10. Human Genotyping AccuPower® Real-Time PCR Diagnostic Kits

AccuPower® ApoE Real-Time PCR Kit

APE-1111 PCR premix (24rxn), PCs (E1/E3), DEPC D.W., Optical sealing film

Human apolipoprotein E (ApoE) is a major component of lipoproteins and has an important role in lipoprotein metabolism. ApoE has 3 common alleles (ε2, ε3, ε4) which encode three isoforms of ApoE protein E2, E3, and E4. AccuPower® ApoE Real-Time PCR Kit is designed to determine the genotype of ApoE codon change (112 Arg/Cys, 158 Cys/Arg). The kit is configured for use with Exicycler™ 96 (ExiGenotyper™ software).

● Target - Human ApoE SNP (Cys112Arg, Arg158Cys)● Sample type - Human whole blood, Human buccal swab● Instrument - Exicycler™ 96 (ExiGenotyper™ software)

● Distinct and direct detection of ApoE 6 genotype through allele-specific PCR method

● Highly sensitive detection of ApoE genotype (Table 1) - The LoD is 10 ng/test - Detectable range is 10 ~ 200 ng/test

● No interference observed in the presence of the interfering substances such as EDTA, albumin, hemoglobin, cholesterol, etc.

The AccuPower® ApoE Real-Time PCR Kit provides;Table 1. Limit of Detection of AccuPower® ApoE Real-Time PCR Kit

ApoE SNP 112 (Cys 112 Arg)

Conc. (ng/test)

Sample size S.D C.V(%)

100 24 0.52 2.11

50 24 0.62 1.86

10 24 0.71 1.92

1 24 0.94 2.45


Conc. (ng/test)


100 24 0.51 1.62

50 24 0.86 2.5

10 24 0.78 2.07

1 24 0.93 2.41

Method Direct -sequencing

E2/E3 E2/E4 E3/E3 E4/E4

AccuPower ® ApoE Real -Time PCR Kit

E2/E3 1

E2/E4 2

E3/E3 1

E4/E4 2

Comparison of the AccuPower® ApoE Real-Time PCR Kit with direct-sequencing was performed on 6 clinical samples. AccuPower® ApoE Real-Time PCR Kit determined that 6 specimens were 100% agreement with direct-sequencing method. Real-Time PCR assay using a kit from company A showed almost false-genotyping result compared with direct-sequencing method (Table 2).

Correlation with Reference Method Table 2. Comparison test results of AccuPower® ApoE Real-Time PCR Kit and Direct-sequencing


Conc. (ng/test)


100 24 0.52 2.11

50 24 0.62 1.86

10 24 0.71 1.92

1 24 0.94 2.45


Conc. (ng/test)


100 24 0.51 1.62

50 24 0.86 2.5

10 24 0.78 2.07

1 24 0.93 2.41

Method Direct -sequencing

E2/E3 E2/E4 E3/E3 E4/E4

AccuPower ® ApoE Real -Time PCR Kit

E2/E3 1

E2/E4 2

E3/E3 1

E4/E4 2



K-4411 ExiPrep™ Dx Blood Genomic DNA Kit 96

ExiGenotyper™ software automatically interprets ApoE SNP results in real-time. ApoE phenotypes and genotypes are analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure1).

Figure 1. Example of AccuPower® ApoE Real-Time PCR Kit result

Auto-interpretation of ApoE gene SNPs

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WAF-1111 PCR premix (12rxn), PCs (W1/W2/W3/W4/W5/W6/W7/W8), DEPC D.W., Optical sealing film.

Warfarin as a coumarin derivative is an anticoagulant that inhibits the biosynthesis of coagulant factor. Determining an optimal warfarin dose is essential to reduce side effect like hemorrhage. With this, analysis of SNPs in the genes, VKORC1 and CYP2C9, is shown to be closely related to the metabolism of anticoagulation drugs such as warfarin in individuals. This is why a fast and reliable test method is essential for prompt dose adjustment to prevent serious over- or under-dosing effects. AccuPower® Warfarin genotyping Kit is designed to determine the genotype of warfarin SNPs within VKORC1 and CYP2C9 gene. The kit is configured for use with Exicycler™ 96 (ExiGenotyper™ software).

● Target - * Human VKORC1 gene SNP (3673 G>A, 6484 C>T, 6853G>C, 9041 G>A) * Human CYP2C9 gene SNP (430 C>T, 1075 A>C)● Sample type - Human whole blood, Human buccal swab

● Instrument - Exicycler™ 96 (ExiGenotyper™ software)




● Distinct and direct detection of wafarin SNP genotype through

allele-specific PCR method● Highly sensitive detection of warfarin SNP genotype - The LoD is 10 ng/test - Detectable range is 10 ~ 200 ng/test● No interference observed in the presence of the interfering substances such as

albumin, cholesterol, bilirubin, etc.

The clinical evaluation of the AccuPower® Warfarin genotyping Kit was performed on 82 clinical samples. AccuPower® Warfarin genotyping assay determined that 82 specimen results were 100% agreement with direct-sequencing method (Table 1).

ExiGenotyper™ software automatically interprets warfarin SNP results in real-time. Warfarin SNP genotypes are analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure 1).

Figure1. Example of AccuPower® Warfarin genotyping Kit result

The AccuPower® Warfarin genotyping Kit provides;


Automatic Analysis of VKORC1/CYP2C9 SNPs

Table 1. Comparison test results of AccuPower® Warfarin genotyping Kit*Thrombosis Research Volume 130, Issue 1, Pages 104–109, July 2012

AccuPower® Warfarin genotyping Kit

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AccuPower® HLA-B27 Real-Time PCR Kit

HLB-1111 PCR premix (96rxn), PC, NC, NTC, DEPC D.W., Optical sealing film

The function of the human leukocyte antigen (HLA) system is to present antigen molecules to a variety of cell types including most immune cells. The HLA system plays a large role in infectious diseases, graft rejection and autoimmunity. HLA-B27 serotype is found in more than 90% of ankylosing spondylitis patients. HLA genes have been extensively investigated in the clinic and are screened for organ transplant fitness screening or DNA fingerprinting. AccuPower® HLA-B27 Real-Time PCR Kit is designed to detect HLA-B27 gene and configured for use with Exicycler™ 96 (ExiGenotyper™ software).

● Target - Human HLA-B27 gene● Sample type - Human whole blood, Human buccal swab● Instrument - Exicycler™ 96 (ExiGenotyper™ software)

● Specific detection of HLA-B27 gene

● Highly sensitive detection of HLA-B27 gene - The LoD is 0.26 ng/test (Cut-off is 10 ng/ul) - Detectable range is 10 ~ 200 ng/test

● No interference observed in the presence of the interfering substances such as EDTA, hemoglobin, albumin, cholesterol, etc.

The AccuPower® HLA-B27 Real-Time PCR Kit provides; Table 1. Comparison test results of AccuPower® HLA-B27 Real-Time PCR Kit and A/B Univ. hospitals on clinical samples.

The clinical evaluation of the AccuPower® HLA-B27 Real-Time PCR Kit was performed on 166 clinical samples. AccuPower® HLA-B27 Real-Time PCR kit was showed sensitivity of 98%, specificity of 100 % (Table 1).





ExiGenotyper™software automatically analyzes HLA-B27 gene detection results in real-time. The results are analyzed based on the Ct value calculated from each sample amplification result (Figure 1).

Figure1. Example of AccuPower® HLA-B27 Real-Time PCR Kit resultGreen signal; HLA-B27, Black signal; IPC

Automatic Analysis of HLA-B27 Detection Results

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AccuPower® CYP2C19 Real-Time PCR Kit

C19-1111 PCR premix (24rxn), PCs (W/M), DEPC D.W., Optical sealing film

The CYP2C19 gene is a subtype of cytocrome p450 which is known to be involved in drug metabolism like a plavix®. If CYP2C19 SNP genotype is a varient type, the drug metabolism is poor (PM; poor metabolism). If CYP2C19 SNP genotype is a heterozygous type, the drug metabolism is intermediate (IM; Intermediate metabolism). AccuPower® CYP2C19 Real-Time PCR Kit is designed to determine the genotype of CYP2C19 SNPs and configured for use with Exicycler™ 96 (ExiGenotyper™ software).




● Distinct and direct detection of CYP2C19 SNP genotype through allele- specific PCR method

● Highly sensitive detection of CYP2C19 SNP - The LoD is 1 ng/test - Detectable range is 1 ~ 200 ng/test

● No interference observed in the presence of the interfering substanc-es such as EDTA, hemoglobin, albumin, cholesterol, etc.

The clinical evaluation of the AccuPower® CYP2C19 Real-Time PCR Kit was performed on 59 clinical samples for comparison test with reference method, CE IVD certified kit, and 26 clinical samples for comparison test with direct-sequencing method. AccuPower® CYP2C19 Real-Time PCR kit was showed 100% agreement with CE IVD certified kit and direct-sequencing method (Table 1).

ExiGenotyper™software automatically interprets CYP2C19 SNP results in real-time. CYP2C19 SNP genotypes are analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure 1).

Figure1. Example of AccuPower® CYP2C19 Real-Time PCR Kit result.

The AccuPower® CYP2C19 Real-Time PCR Kit provides;


Automatic Analysis of CYP2C19 *2, *3 SNPs

Table 1. Comparison test results of AccuPower® CYP2C19 Real-Time PCR Kit and direct-sequencing.

● Target - Human CYP2C19 gene SNPs (*2, *3)● Sample type - Human whole blood, Human buccal swab● Instrument - Exicycler™ 96 (ExiGenotyper™ software)

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TPM-1111 PCR premix (12rxn), PCs (T1/T2/T3/T4/T5/T6), DEPC D.W., Optical sealing film

The TPMT (Thiopurine S-methyltransferase) gene encodes a protein that catalyses S-methylation of aromatic & heterocyclic sulfhydryl compounds. If a normal dose is prescribed to patients with a reduced TPMT activity, a side effect like a pancytopenia may occur. TPMT activity can be estimated through the SNP genotyping of the TPMT gene (238 G>C, 460 G>A, 719 A>G). AccuPower® TPMT genotyping Real-Time PCR Kit is designed to determine the genotype of TPMT SNPs and configured for use with Exicycler™ 96 (ExiGenotyper™ software).




● Distinct and direct detection of TPMT SNP genotype through allele-specific PCR method

● Highly sensitive detection of TPMT SNP - The LoD is 1 ng/test - Detectable range is 1 ~ 200 ng/test

● No interference observed in the presence of the interfering substances such as albumin, cholesterol, billirubin, etc.

The clinical evaluation of the AccuPower® TPMT genotyping Real-Time PCR Kit was performed on 246 clinical samples. AccuPower® TPMT genotyping Real-Time PCR assay determined that 246 specimen results were 100% agreement with direct-sequencing method (Table 1).

ExiGenotyper™software automatically interprets TPMT SNP results in real-time. TPMT SNP genotypes are analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure 1).

Figure1. Example of AccuPower® TPMT genotyping Real-Time PCR Kit result.

The AccuPower® TPMT genotyping Real-Time PCR Kit provides;


Automatic Analysis of TPMT *2, *3A, *3C SNPs

Table 1. Comparison test results of AccuPower® TPMT genotyping Real-Time PCR Kit and direct-sequencing. *BioMed Research International Vol. 2013, Pages 4, Jan 2013

SNPs Concordance(%) Sequencingvs. Real-Time PCR

238

460

719

GG (n=11) GC (n=0) CC (n=0) GG (n=10) GA (n=0) AA (n=4) AA (n=4) GA (n=7) GG (n=0)

11 (100) 0 0

10(100) 1(100)

0 4(100) 7(100)

0

● Target - Human TPMT gene SNPs (*2, *3A, *3C)● Sample type - Human whole blood, Human buccal swab● Instrument - Exicycler™ 96 (ExiGenotyper™ software)

AccuPower® TPMT genotyping Real-Time PCR Kit

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AccuPower® MTHFR Real-Time PCR Kit AccuPower® MTHFR (C677T, A1298C) Real-Time PCR Kit

MHR-1111 PCR premix (24rxn)MTH-1111 PCR premix (48rxn) Common components: PCs (W/M), DEPC D.W., Optical sealing film

MTHFR is an enzyme that converts 5, 10-methylenetetrahydrofolate to 5-methyltetrahydrofolate, a substrate for homocysteine remethylation to methionine. If MTHFR enzyme activity is reduced, methionine synthesis metabolism is inhibited and homocysteine concentration is increased (hyperhomocysteinemia), which may result in vascular disease and venous thromboembolism. MTHFR enzyme activity is reported to be related to SNPs of the MTHFR gene (677C>T, 1298A>C). AccuPower® MTHFR Real-Time PCR Kit is designed to determine the genotype of MTHFR SNPs and configured for use with Exicycler™ 96 (ExiGenotyper™ software).

● Target - Human MTHFR gene SNPs● Sample type - Human whole blood, Human buccal swab● Instrument - Exicycler™ 96 (ExiGenotyper™ software)

● Distinct and direct detection of MTHFR SNP genotype through allele-specific PCR method

● Highly sensitive detection of MTHFR SNP - The LoD is 10 ng/test - Detectable range is 10 ~ 200 ng/test


The AccuPower® MTHFR/ MTHFR (C677T, A1298C) Real-Time PCR Kit provides;

SNPs Concordance (%)

SNPs Concordance (%)

Sequencing ExiGenotyper

Sequencing ExiGenotyper

677 C>T CC (n=5) CT (n=6) TT (n=1)

5 (100) 6 (100) 1 (100)

1298 A>C

AA (n=8) AC (n=3) CC (n=1)

8 (100) 3 (100) 1 (100)

Table1. Comparison test results of AccuPower® MTHFR Real-Time PCR Kit and direct-sequencing on clinical samples.

The clinical evaluation of the AccuPower® MTHFR/MTHFR (C677T, A1298C) Real-Time PCR Kit was performed on 12 clinical samples. AccuPower® MTHFR /MTHFR (C677T, A1298C) Real-Time PCR Kit determined that 12 specimen results were 100% agreement with direct-sequencing method. MTHFR 677/1298 conventional PCR kit of A company showed few false-genotyping results compared with direct-sequencing (Table 1).





ExiGenotyper™software automatically interprets MTHFR SNP results in real-time. MTHFR SNP genotype(s) are analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure 1).

Figure 1. Example of AccuPower® MTHFR (C677T, A1298C) Real-Time PCR Kit result

Automatic Analysis of MTHFR gene SNPs

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JAK-1111 PCR premix (48rxn), SPCs (Wild type/Mutant) DEPC D.W., Optical sealing film

The JAK2 (Janus Kinase 2) gene has been reported to be related to MPD (Myeloproliferative Disorder). Studies has revealed that 90% mutation ratio of JAK2 V617F is found in PV (Polycythemia Vera) patients, 35%-70% mutation ratio in ET (Essential Thrombocythemia) patients, and 50% mutation ratio in Myelofibrisis patients. AccuPower® JAK2 V617F Quantitative PCR Kit is designed for the quantification of each JAK2 wild type and mutant type to determine the mutant ratio. The kit is configured for use with Exicycler™ 96 (ExiGenotyper™ software).

AccuPower® JAK2 V617F Quantitative PCR Kit

Related Products




● Reliable quantification of JAK2 SNP through allele-specific PCR method

● Highly sensitive detection of JAK2 SNP - The LoD is 1 ng/test (mutation ratio 0.01%) - Detectable range is 1 ~ 200 ng/test

● No interference observed in the presence of the interfering sub-stances such as EDTA, hemoglobin, albumin, cholesterol, etc.

The clinical evaluation of the AccuPower® JAK2 V617F Quantitative PCR Kit was performed on 10 clinical samples. AccuPower® JAK2 V617F quantification determined that 10 specimen results were 95% agreement with direct-sequencing method (Figure 1).

ExiGenotyper™software automatically analyzes JAK2 V617F mutation ratio in real-time. The mutation ratio is analyzed based on the quantified each allele specific amplification result(Figure 2). The detectable limit of JAK2 mutation ratio is 0.01%.

Figure 2. Example of AccuPower® JAK2 V617F Quantitative PCR Kit result

The AccuPower® JAK2 V617F Quantitative PCR Kit provides;


Automatic Analysis of JAK2 V617F Mutation Ratio

Figure 1. Comparison test results of AccuPower® JAK2 V617F Quantitative PCR Kit and direct-sequencing on clinical samples.

● Target - Human JAK2 gene V617F SNP● Sample type - Human whole blood, Human buccal swab● Instrument - Exicycler™ 96 (ExiGenotyper™ software)

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AccuPower® Factor V Leiden Real-Time PCR Kit

FVL-1111 PCR premix (48rxn), PCs (W/M), DEPC D.W., Optical sealing film

Factor V Leiden thrombophilia is characterized by a poor anticoagulant response to activated protein C (APC). The term “Factor V Leiden” refers to the specific G-to-A substitution at nucleotide 1691 of the gene for Factor V to result in a single amino acid replacement (R506Q) at one of three APC cleavage sites in the factor V molecule. AccuPower® Factor V Leiden Real-Time PCR Kit is designed to determine the genotype of Factor V SNP and configured for use with Exicycler™ 96 (ExiGenotyper™ software).

Related Products




● Distinct and direct detection of Factor V SNP genotype through allele-specific PCR method

● Highly sensitive detection of Factor V SNP - The LoD is 1 ng/test - Detectable range is 1 ~ 200 ng/test


The clinical evaluation of the AccuPower® Factor V Leiden Real-Time PCR Kit was performed on 12 clinical samples. AccuPower® Factor V Leiden Real-Time PCR kit determined that 12 specimen results were 100% agreement with direct-sequencing method (Table 1).

ExiGenotyper™software automatically analyzes Factor V SNP results in real-time. Factor V SNP genotype is analyzed based on the delta Ct value calculated from each allele specific amplification result (Figure 1).

Figure 1. Example of AccuPower® Factor V Leiden Real-Time PCR Kit result

The AccuPower® Factor V Leiden Real-Time PCR Kit provides;


Automatic Analysis of Factor V SNP

Direct-sequencing Method Total

Wild type Heterozygous Mutant

Bioneer Factor V

Leiden

Wild type 4 - - 4

Heterozygous - 4 - 4

Mutant - - 4 4

Total 4 4 4 12

Table 1. Comparison test results of AccuPower® Factor V Leiden Real-Time PCR Kit and direct-sequencing on clinical samples.

● Target - Human Factor V gene SNP (1691 G>A)● Sample type - Human whole blood, Human buccal swab● Instrument - Exicycler™ 96 (ExiGenotyper™ software)

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B-11. Chronic Myelogenous Leukemia AccuPower® Real-Time PCR Diagnostic Kits

CML-1111 BCR-ABL PCR premix (48 rxn), ABL PCR premix (48 rxn), SPCs (S1~S5), Optical sealing film

Philadelphia chromosome or Philadelphia translocation is a specific chromosomal abnormality that is associated with chronic myelogenous leukemia (CML). It is the result of a reciprocal translocation between chromosome 9 (region q34: ABL) and 22 (region q11: BCR). ABL gene expresses a membrane-associated protein, a tyrosine kinase, the BCR-ABL transcript is also translated into a tyrosine kinase, adding a phosphate group to tyrosine. In turn, BCR-ABL activates a number of cell cycle-controlling proteins and enzymes, speeding up cell division. Moreover, it inhibits DNA repair, causing genomic instability and potentially causing the feared blast crisis in CML. The AccuPower® BCR-ABL Quantitative RT-PCR Kit is an in vitro diagnostic kit designed for the quantification of BCR-ABL mutation in human whole blood samples through Real-Time polymerase chain reaction (PCR) using Exicycler™ 96 MDx System.

AccuPower® BCR-ABL Quantitative RT-PCR Kit

● Highly sensitive detection of M-bcr (b3a2, b2a2) mutation ratio (Figure 2)

- 5 log detection ● One-Step Real-Time RT-PCR reaction using Dual-HotStart™

technology

The AccuPower® BCR-ABL Quantitative RT-PCR Kit provides;

Figure 1. Standard Positive Controls (S1 ~ S5) of AccuPower® BCR-ABL Quantitative RT-PCR KitLeft figure: ABL, Right figure : M-bcr

● Target - ABL (reference gene), BCR-ABL(M-bcr) -b3a2, b2a2● Sample type - Human whole blood● Instrument - Exicycler™ 96

Figure 2. Analytical sensitivity of AccuPower® BCR-ABL Quantitative RT-PCR Kit

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B-12. Mosquito-borne Diseases AccuPower® Real-Time PCR Diagnostic Kits

AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit

ZIK-1111 PCR premix(96rxn), PC, IPC, NTC,DEPC D.W., Optical sealing film

Infection of Zika(ZIKV), Dengue(DENV) and Chikungunya(CHIKV) viruses are referred to as mosquito-borne diseases since they are transmitted by mosquitoes. Over one million people die from these diseases every year. ZIKV, DENV and CHIKV have similar symptoms and a common vector, Aedes aegypti. Especially, the risk of microcephaly is increased in newborn baby borned from mother who had ZIKV infection. Therefore simultaneous diagnosis of these viruses is important. The AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit is an in vitro diagnostic kit designed for qualification of ZIKV, DENV and CHIKV RNA simultaneously in human samples, such as serum and plasma samples, through Real-Time polymerase chain reaction (RT-PCR).

Related Products

Cat. no. Kit name Instrument Tests

ZIK-1111 AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit Exicycler™ 96 96

ZIK-1112 AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit ABI7500, CFX 96 96


K-4471 ExiPrep™ Dx Viral DNA/RNA kit 96

K-4473 ExiPrep™ Dx Viral RNA kit 96

● Multiplex detection of ZIKV, DENV and CHIKV in a tube

● Highly sensitive detection of each viruses - LoD of ZIKV : 15.48 copies/ml - LoD of DENV : 15.80 copies/ml - LoD of CHIKV : 18.60 copies/ml● Specific one-step Real-Time RT-PCR reaction using Dual-HotStart™

technology● No interference observed in the presence of the interfering substances

The AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit provides;

Figure 1. Detection of ZIKV,DENV and CHIKV Positive Control using Exicycler ™96Green signal: ZIKV, Black signal : DENV, Red signal : CHIKV, Yellow signal IPC

● Target - Zika, Dengue and Chikungunya virus RNA● Sample type - Serum, Plasma (for ZIKV,DENV and CHIKV), Urine (for ZIKV only)● Instrument - Exicycler™ 96, ExiStation™

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References AccuPower® Real-Time PCR Diagnostic Kits

Category Reference Journal

HBV Comparison of MagNA Pure 96, Chemagic MSM1, and QIAamp MinElute for Hepatitis B Virus Nucleic Acid Extraction

Annals of Clinical & Laboratory Science

HBV Performance evaluation of ExiStation HBV diagnostic system forhepatitis B virus DNA quantitation

Journal Of Virological Methods

BCI Blood Screening

An evaluation of the Bioneer’s multiplex AccuPower® BCI blood screening kit Vox Sanguinis

HLA Evaluation of Two Commercial HLA-B27 Real-Time PCR Kits Korean Journal of Laboratory Medicine

IFA Clinical Characteristics and Comparison of the Various Methods Used for the Diagnosis of the New Influenza A Pandemic in Korea

Laboratory Medicine Online

IFA Evaluation of Direct Immunofluorescence Test with PCR for Detection of Novel Influenza A (H1N1) Virus during 2009 Pandemic

Yonsei Medical Journal cal Journal

IFA Characteristics of Hospitalized Children with 2009 Pandemic Influenza A (H1N1): A Multicenter Study in Korea

Journal Of Korean Medical Science

IFA Positive Rates of 2009 Novel Influenza A (H1N1) was High in School-Aged Individuals: Significance in Pandemic Control


MAL A novel real-time PCR assay for the detection of Plasmodium falciparum and Plasmodium vivax malaria in low parasitized individuals Acta Tropica

MAL A Case of Plasmodium ovale Malaria Imported from West Africa Korean Journal Of Parasitology

MP Macrolide Resistance of Mycoplasma pneumoniae and Its Detection Rate by Real-Time PCR in Primary and Tertiary Care Hospitals Ann Lab Med

MP Two Cases of Mycoplasma pneumoniae Pneumonia with A2063G Mutation in the 23S rRNA Gene in Siblings Ann Lab Med

MTB Proportion of Multidrug-Resistant Tuberculosis in Human Immunodeficiency Virus/Mycobacterium tuberculosis Co-Infected Patients in Korea


MTB Comparison of 14 Molecular Assays for Detection of Mycobacterium tuberculosis Complex in Bronchoalveolar Lavage Fluid

Journal of Clinical Microbiology

NOR Evaluation of a New Immunochromatographic Assay Kit for the Rapid Detection of Norovirus in Fecal Specimens Ann Lab Med

NORUpdates on the genetic variations of Norovirus in sporadic gastroenteritis in Chungnam Korea, 2009-2010 Virology Journal

NOR Evaluation of a new real-time reverse transcription polymerase chain reaction assay for detection of norovirus in fecal specimens

Diagnostic Microbiol-ogy and Infectious Disease

STIPrevalence and Associated Factors for Four Sexually Transmissible Microorganisms in Middle-Aged Men Receiving General Prostate Health Checkups: A Polymerase Chain Reaction-Based Study in Korea

Korean Journal of Urology

TPMT Validation of New Allele-Specific Real-Time PCR System for Thiopurine Methyltransferase Genotyping in Korean Population

BioMed Research International

WAFNew allele-specific real-time PCR system for warfarin dose genotyping equipped with an automatic interpretative function that allows rapid, accurate, and user-friendly reporting in clinical laboratories

Thrombosis Research

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ExiPrep™ Dx Nucleic Acid Extraction Kits ·····················································································44

C-1. Viral DNA/RNA Kit ·················································································································································· 46

C-2. Blood Viral DNA Kit ··············································································································································· 46

C-3. Bacteria Genomic DNA Kit ································································································································· 47

C-4. Mycobacteria Genomic DNA Kit ····················································································································· 47

C-5. Blood Genomic DNA Kit ····································································································································· 48

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Features

Success in molecular diagnostic detection and analysis requires effective method in the nucleic acid extraction from various sample types. For that, ExiPrep™ Dx Nucleic Acid Extraction Kit series provide a convenient and efficient method for the isolation and purification of nucleic acids from a variety of samples including blood, urine, sputum, BAL and respiratory swabs so on. Based on this, Bioneer’s kits offer various isolation systems for special testing purpose, assuring high-quality nucleic acid purification.

ExiPrep™ Dx Nucleic Acid Extraction Kits


● Using the automated clinical nucleic acid extraction instrument ExiPrep™16 Dx

● Target nucleic acids can be extracted from 1 to 16 samples simultaneously

● Optimized protocols for nucleic acid extraction according to sample types are pre-installed for reproducible results

● ExiPrep™16 Dx system use silica magnetic beads developed and produced with Bioneer’s technology

Workflow

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EZ Solution is easy sputum liquefying solution containing strong reducing agent. The sputum pretreatment process using EZ Solution doesn’t require time consuming centrifuging and washing steps. This innovation make the sputum treatment simpler, faster and even more effective compared to the method using NaOH.

Kit Components

EZ Solution

Selection Guide

Buffer cartridge ① 6eaBuffer cartridge ② 6ea

Protection cover(3ea) 4 packs

Disposable filter tip(32 ea) 3 packs

Waste tray(3ea) 1 pack

Elution tube (12ea) 1 pack &Contamination shield filter paper (12ea) 1 pack

Sample loading tube6 packs

Related nucleic acid prep kits ExiPrep™ Dx Viral

DNA/RNA

ExiPrep™ Dx Viral

DNA

ExiPrep™ Dx Viral

RNA

ExiPrep™ Dx Blood Viral DNA

ExiPrep™ Dx Bacterial

Genomic DNA

ExiPrep™ Dx Mycobacteria

Genomic DNA

ExiPrep™ Dx Blood

Genomic DNADiagnostic Kits

AccuPower® CP Real-Time PCR KitAccuPower® MP Real-Time PCR Kit

AccuPower® MERS-CoV Real-Time RT-PCR KitAccuPower® MERS-CoV (upE&ORF1a) Real-Time RT-PCR Kit

AccuPower® Gastrointestinal Pathogen Real-Time RT-PCR Kit

AccuPower® CMV Quantitative PCR Kit

AccuPower® EBV Quantitative PCR Kit

AccuPower® BKV Quantitative PCR Kit

AccuPower® ZIKV(DENV,CHIKV) Multiplex Real-Time RT-PCR Kit

AccuPower® Genotyping Real-Time PCR Kits

AccuPower® HPV 16&18 Real-Time PCR Kit

AccuPower® In�uenza A Real-Time RT-PCR Kits

AccuPower® HSV type1 & type2 Real-Time PCR Kit

AccuPower® STI related Real-Time PCR Kits

AccuPower® TB related Real-Time PCR Kits

AccuPower® BCI Blood screening Kit

AccuPower® HCV Quantitative RT-PCR Kit

AccuPower® HBV Quantitative PCR Kit

AccuPower® HIV-1 Quantitative RT-PCR Kit

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C-1. ExiPrep™ Dx Viral DNA/RNA Kit ExiPrep™ Dx Nucleic Acid Extraction Kits

ExiPrep™ Dx Viral DNA/RNA Kit

ExiPrep™ Dx Blood Viral DNA Kit

ExiPrep™ Dx Viral DNA/RNA Kit is designed for the high-yield extraction of viral DNA or RNA in clinical samples using the ExiPrep™16 Dx.

Figure 1. Quantification of HBV viral load was performed to evaluate ExiPrep™ Dx Viral DNA Kit. Viral DNA was extracted from serum using the kit, and Real-Time PCR was performed with the AccuPower® HBV Quantitative PCR Kit on Exicycler™ 96 (Black signal; HBV, Blue signal; IPC).

Figure 2. Quantification of HIV type 1 viral load was performed to evaluate ExiPrep™ Dx Viral RNA Kit. Viral RNA was extracted from serum using the kit, and Real-Time PCR was performed with the AccuPower® HIV-1 Quantitative RT-PCR Kit on Exicycler™ 96 (Black signal; HIV-1, Blue signal; IPC).

Experimental Data

Specifications

ExiPrep™ Dx Blood Viral DNA Kit is for the extraction of viral DNA from whole blood using the automated clinical nucleic acid extraction instrument ExiPrep™16 Dx.

Cat. no. Kit name Sample types Initial vol. Elution vol.

K-4471 ExiPrep™ Dx Viral DNA/RNA KitSerum, Plasma, Swab,

Urine, Stool, CSF 400 ul 50 ulK-4472 ExiPrep™ Dx Viral DNA Kit

K-4473 ExiPrep™ Dx Viral RNA Kit

Specifications

Specifications

C-2. ExiPrep™ Dx Blood Viral DNA Kit

BioneerA companyNominal

concentration N Measured Concentration

SD(Log IU/ml)

Positive sample 2 2255 IU/ml 0.24 1848 IU/ml

5000 IU/ml 8 4592 IU/ml 0.07 4762 IU/ml

500 IU/ml 8 520 IU/ml 0.17 598 IU/ml

250 IU/ml 8 234 IU/ml 0.22 179 IU/ml

100 IU/ml 8 105 IU/ml 0.33 108 IU/ml

Figure 1. Serial dilutions of blood samples (5x103 ~ 5x107 copies/ml) containing EBV was processed according to the kit protocol.

Table 1. Quantification of EBV was performed to compare the efficiency of ExiPrep™ Dx Blood Viral DNA Kit with competitor kit.

Cat. no. Sample types Initial vol. Elution vol.

K-4474 Human whole blood 200 ul 50 ul

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C-3. ExiPrep™ Dx Bacteria Genomic DNA Kit

C-4. ExiPrep™ Dx Mycobacteria Genomic DNA Kit


ExiPrep™ Dx Bacteria Genomic DNA Kit

ExiPrep™ Dx Mycobacteria Genomic DNA Kit

Specifications

Specifications


K-4414 Sputum, Urine, Swab 400 ul 50 ul


K-4418 Sputum, Urine, BAL 400 ul 50 ul

ExiPrep™ Dx Mycobacteria Genomic DNA Kit is designed for the high-yield extraction of mycobacteria genomic DNA in clinical samples using the ExiPrep™16 Dx. EZ Solution, sputum liquefying solution, makes the DNA extraction easier and faster.

Figure1. Detection of Ureaplasma urealyticum was performed to to compare the efficiency of ExiPrep™ Dx Bacteria Genomic DNA Kit with reference method, boiling preparation and Real-Time PCR was performed with the AccuPower® UU Real-Time PCR Kit on Exicycler™ 96 (Black signal; UU, Blue signal; IPC).

ExiPrep™ Dx Bacteria Genomic DNA Kit is designed for the high-yield extraction of bacteria DNA in clinical samples using the ExiPrep™16 Dx.

Experimental Data

ExiPrep™ Dx Bacteria Genomic DNA Kit Boiling Method

EZ Solution vs NaOH: Sputum Pretreatment

Figure 1. Sputum pretreatment procedure using EZ Solution and 1N NaOH. The process using EZ Solution is simpler, faster and even effective. No centrifuge, no washing steps are required.

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C-5. ExiPrep™ Dx Blood Genomic DNA Kit ExiPrep™ Dx Nucleic Acid Extraction Kits

ExiPrep™ Dx Blood Genomic DNA Kit

Specifications

ExiPrep™ Dx Blood Genomic DNA Kit is for the extraction of human DNA from whole blood using the automated clinical nucleic acid extraction instrument ExiPrep™16 Dx.

Figure 2. Genotyping of ApoE SNP was performed to compare the efficiency of ExiPrep™ Dx Blood Genomic DNA Kit with competitor kit. Genomic DNA was extracted from whole blood using the ExiPrep™ Dx Blood Genomic DNA Kit, and Real-Time PCR was performed with the AccuPower® ApoE Real-Time PCR Kit on Exicycler™ 96.

Experimental Data


K-4411 Human whole blood 200 ul 70 ul

Figure 1. Results of gel electrophoresis run on Agaro-Power™ System (A-7020, Bioneer) and DNA concentration or purity estimation of genomic DNAextracted from human blood 200ul (A1, A2; A company, 1, 2, 3, 4, 5, 6; BIONEER).

Ordering Information ························································································································· 50

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Cat. no. Product Name Q` ty

MDx Instruments

A-2200 ExiStation™ Universal Molecular Diagnostic System Each

A-2100 ExiStation™ HT Each

A-2060 Exicycler™ 96 Real-Time Quantitative Thermal Block Each

A-5050 ExiPrep™16 Dx Automated Nucleic Acid Extraction System Each

A-5150 ExiPrep™ 48 Dx Each

A-7040 ExiSpin™ Each

Diagnostic kits for use on the Exicycler™ 96

Human Immunodeficiency Virus

HIV-1111 AccuPower® HIV-1 Quantitative RT-PCR Kit 96Tests

Hepatitis Virus

HBV-1111 AccuPower® HBV Quantitative PCR Kit 96Tests

HCV-1111 AccuPower® HCV Quantitative RT-PCR Kit 96Tests

BCI Blood Screening

BCI-1111 AccuPower® BCI Blood Screening Kit 96Tests

Mycobacterium Tuberculosis

TBMDR-1111 AccuPower® TB&MDR Real-Time PCR Kit 48Tests

MTN-1111 AccuPower® MTB&NTM Real-Time PCR Kit 96Tests

MTB-1111 AccuPower® MTB Real-Time PCR Kit 96Tests

NTM-1111 AccuPower® NTM Real-Time PCR Kit 96Tests

Sexually Transmitted Infections

STI8A-1111 AccuPower® STI8A-Plex Real-Time PCR Kit 0197 96Tests

STI8B-1111 AccuPower® STI8B-Plex Real-Time PCR Kit 96Tests

STD2A-1211 AccuPower® CT & NG Real-Time PCR Kit 0197 96Tests

CHT-1111 AccuPower® CT Real-Time PCR Kit 0197 96Tests

NSG-1111 AccuPower® NG Real-Time PCR Kit 96Tests

MPG-1111 AccuPower® MG Real-Time PCR Kit 96Tests

UUU-1111 AccuPower® UU Real-Time PCR Kit 96Tests

MPH-1111 AccuPower® MH Real-Time PCR Kit 96Tests

TVG-1111 AccuPower® TV Real-Time PCR Kit 96Tests

HSM-1111 AccuPower® HSV type 1&2 Real-Time PCR Kit 96Tests

CANGV-1111 AccuPower® CA&GV Real-Time PCR Kit 96Tests

HV6-1111 AccuPower® HHV6 Real-Time PCR Kit 96Tests

HV8-1111 AccuPower® HHV8 Real-Time PCR Kit 96Tests

TGN-1111 AccuPower® TG Real-Time PCR Kit 96Tests

Transplantation related Virus

CMV-1111 AccuPower® CMV Quantitative PCR Kit 96Tests

EBV-1111 AccuPower® EBV Quantitative PCR Kit 96Tests

BKV-1111 AccuPower® BKV Quantitative PCR Kit 96Tests

Human Papillomavirus

HPM-1111 AccuPower® HPV 16&18 Real-Time PCR Kit 96Tests

HPG-1111 AccuPower® HPV Genotyping Kit 12Tests

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Cat. no. Name Q` ty

Respiratory Pathogens

SIA-1111 AccuPower® New Inf A (H1N1) & Inf A Real-Time RT-PCR Kit 48Tests

IFA-1111 AccuPower® Influenza A Real-Time RT-PCR Kit 96Tests

SIV-1111 AccuPower® New Inf A (H1N1) Real-Time RT-PCR Kit 96Tests

CPN-1111 AccuPower® CP Real-Time PCR Kit 96Tests

MPN-1111 AccuPower® MP Real-Time PCR Kit 96Tests

COV-1111 AccuPower® MERS-CoV Real-Time RT-PCR Kit 96Tests

COV-1112 AccuPower® MERS-CoV (upE&ORF1a) Real-Time RT-PCR Kit 48Tests

Gastrointestinal Pathogens

NOR-1111 AccuPower® Norovirus Real-Time RT-PCR Kit 96Tests

ENT-1111 AccuPower® EV Real-Time RT-PCR Kit 96Tests

E71-1111 AccuPower® Enterovirus 71 Real-Time RT-PCR Kit 96Tests

Human Genotyping

APE-1111 AccuPower® ApoE Real-Time PCR Kit 24Tests

WAF-1111 AccuPower® Warfarin genotyping Kit 12Tests

HLB-1111 AccuPower® HLA-B27 Real-Time PCR Kit 96Tests

C19-1111 AccuPower® CYP2C19 Real-Time PCR Kit 24Tests

TPM-1111 AccuPower® TPMT genotyping Real-Time PCR Kit 12Tests

MHR-1111 AccuPower® MTHFR (C677T, A1298C) Real-Time PCR Kit 24Tests

MTH-1111 AccuPower® MTHFR Real-Time PCR Kit 48Tests

JAK-1111 AccuPower® JAK2 V617F Quantitative PCR Kit 48Tests

FVL-1111 AccuPower® Factor V Leiden Real-Time PCR Kit 48Tests

Chronic Myelogenous Leukemia

CML-1111 AccuPower® BCR-ABL Quantitative RT-PCR Kit 48Tests

Mosquito-borne Diseases

ZIK-1111 AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit 96Tests

ZIK-1112 AccuPower® ZIKV (DENV, CHIKV) Multiplex Real-Time RT-PCR Kit 96Tests

Nucleic acid extraction kits for use on the ExiPrep™16 Dx

K-4471 ExiPrep™ Dx Viral DNA/RNA Kit 96Tests

K-4472 ExiPrep™ Dx Viral DNA Kit 96Tests

K-4473 ExiPrep™ Dx Viral RNA Kit 96Tests

K-4474 ExiPrep™ Dx Blood Viral DNA Kit 96Tests

K-4411 ExiPrep™ Dx Blood Genomic DNA Kit 96Tests

K-4414 ExiPrep™ Dx Bacteria Genomic DNA Kit 96Tests

K-4418 ExiPrep™ Dx Mycobacteria Genomic DNA Kit 96Tests

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