the new r&d and manufacturing plant in spello • perugia ... diametra 2015.pdf · the new...

The new R&D and Manufacturing Plant in Spello • Perugia • Italy

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The company is ISO 13485 certified and our products are CE marked according to 98/79/EC Directive.

DiaMetra mission is to support the professionals work providing reliable reagents and excellent service.The proprietary technologies, the long term experience and the commitment of DiaMetra people, has led our company

gaining reliability, flexibility, always keeping as mission the full satisfaction of the customer

Certifications

QUALITY MANAGEMENT SYSTEM - ISO 9001:2008

This is to certify that:

DiaMetra S.r.l.Via Garibaldi, 18Segrate (MI)20090Italy

Holds Certificate No: FM 71943

and operates a Quality Management System which complies with the requirements of ISO 9001:2008 for the following scope:

The design, manufacture and distribution of in-vitro diagnostic kits.The design, manufacture and distribution of in-vitro diagnostic kits.

For and on behalf of BSI:

Gary Fenton, Global Assurance Director

Originally Registered: 01/06/2003 Latest Issue: 05/18/2012 Expiry Date: 05/06/2015

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This certificate remains the property of BSI and shall be returned immediately upon request.An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectoryTo be read in conjunction with the scope above or the attached appendix.Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A Member of the BSI Group of Companies.

QUALITY MANAGEMENT SYSTEM - ISO 13485: 2003


DiaMetra S.r.l.Via Garibaldi, 18Segrate (MI)20090Italy

Holds Certificate No: FM 556960

and operates a Quality Management System which complies with the requirements of ISO 13485: 2003 for the followingscope:

The design, manufacture and distribution of in-vitro diagnostic kits for chemicalchemistry and immunochemistry.The design, manufacture and distribution of in-vitro diagnostic kits for chemicalchemistry and immunochemistry.


VP Regulatory Affairs, BSI Group America Inc.

Originally Registered: 06/16/2010 Effective Date: 05/31/2012 Expiry Date: 04/23/2015

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This certificate remains the property of BSI and shall be returned immediately upon request.An electronic certificate can be authenticated online. Printed copies can be validated at www.bsigroup.com/ClientDirectoryTo be read in conjunction with the scope above or the attached appendix.Americas Headquarters: BSI Group America Inc., 12110 Sunset Hills Road, Suite 200, Reston, VA 20190, USA.A Member of the BSI Group of Companies.

QUALITY MANAGEMENT SYSTEM - ISO 13485: 2003


DiaMetra S.r.l.Via Garibaldi, 18Segrate20090Italy

Holds Certificate No: MD 507598

and operates a Quality Management System which complies with the requirements of ISO 13485: 2003 for the followingscope:

The design, manufacture and distribution of in-vitro diagnostic kits.The design, manufacture and distribution of in-vitro diagnostic kits.


Gary Fenton, Global Assurance Director

First Issued: 22/09/2006 Latest Issue: 01/05/2012 Expiry Date: 06/05/2015

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This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.An electronic certificate can be authenticated online.Printed copies can be validated at www.bsigroup.com/ClientDirectory

Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 845 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A Member of the BSI Group of Companies.

• Monoclonal An�body for a be er reproducibility and specificity

• Less interferences of matrix effect in samples

• Easy to automate

• Unsurpassed sensi�vity

• Excellent correla�on versus Free Androgen Index (Total Testosterone/SHBG)

AUTOIMMUNE DISEASESImmunoenzymatic assay (ELISA) for the quantitative determination of autoantibodies.

Method on microplate (96 breakable wells), TMB.

GASTROENTEROLOGY

Code Item Sensitivity Specificity

DKO106 Anti Deamidated Gliadin Peptides (DGP) IgG 94,1 % >99,0 %DKO107 Anti Deamidated Gliadin Peptides (DGP) IgA >99,00 % 97,6 %DKO108 Anti Tissue Transglutaminase IgA (for export only) 88,5 % >99,0 %DKO109 Anti Tissue Transglutaminase IgG (for export only) 81,0 % 90,9 %DKO140 Anti Transglutaminase IgA 1,0 AU/mL * >99,0%DKO141 Anti Transglutaminase IgG 1,0 AU/mL * >99,0%

THROMBOSIS


DKO110 Anti Beta2 Glycoprotein 1 IgG 76,5 % 95,8 %DKO111 Anti Beta2 Glycoprotein 1 IgM 82,3 % 95,8 %DKO112 Anti Cardiolipin IgM > 99,0 % 81,8 %DKO113 Anti Cardiolipin IgG 75,0 % 70,0 %DKO114 Anti Phospholipid Screen IgG 92,3 % IgG 84,6 %

IgM 68,8 % IgM >99,0 %DKO144 Anti Cardiolipin screen IgG 75,0% 70,0 %

IgM >99,0% 81,9 %DKO145 Anti Beta2 Glycoprotein 1 Screen IgG 76,6 % 95,8 %

IgM 82,3 % 95,8 %

* sensitivity expressed as minimum detection limit

ANCA VASCULITIS


DKO091 Anti PR-3 (c-ANCA) >99,0 % >99,0 %DKO092 Anti MPO (p-ANCA) >99,0 % >99,0 %

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AutoImmune Diseases 5

Diabetes 9

Tumor Markers 11

Saliva - Steroid Hormones 13

Saliva tests & devices 13

Steroid Hormones Serum 14

Controls and Calibrators 15

Fertility Proteic Hormones 15

Thyroid Monitoring 17

Hypertension 19

Calcium Metabolism 19

Miscellaneous 19

Index

Autoimmunity Product Line

New• Anti CP IgG

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IMMUNOASSAY Unit

THYROID


DKO085 TSH Receptor Ab 98,0 % >99,0 %DKO115 Anti TG 96,3 % 94,9 %DKO116 Anti TPO 94,0 % 92,9 %DKO176 FAST TRAb 85,0% 100,0%

DIABETES


DKO082 Anti-GAD 92,3 % 88,6 %DKO083 IAA 60,0 % 90,0 %DKO084 IA2 65,3 % 90,0 %DKO123 ZnT8 Ab 68,0 % 99,0 %

RHEUMATOLOGY


DKO094 Anti Centromere B >99,0 % 97,8 %DKO095 Anti dsDNA IgG 93,3 % 95,2 %DKO096 Anti SS-A 94,3 % 94,6 %DKO097 Anti SS-B 80,0 % 98,2 %DKO098 ENA SCREEN 94,7 % 92,3 %DKO099 ANA SCREEN 87,1 % >80,0 %DKO100 Anti Sm >99,0 % 98,4 %DKO101 Anti Scl-70 >99,0 % >99,0 %DKO102 Anti JO-1 90,0 % 98,4 %DKO103 Anti Histone 80,0 AU/mL * 93,2 %DKO104 Anti RNP70 81,2 % >99,0 %DKO105 Anti RNP/Sm 96,1 % >99,0 %DKO117 Anti CCP 79,0 % 97,0 %DKO119 ENA profile 97,7 % > 97,0%DKO129 MMP-3 ♂ 74,0 % ♂ > 99,0 %

♀ 75,0% ♀ 93,0 %DKO149 Anti CP IgG 76,0% 94,0%

* sensitivity expressed as minimum detection limit

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DIABETES MONITORING

Immunoenzymatic assay (ELISA) for the quantitative determination on serum or plasma.Direct method on microplate (96 breakable wells), TMB.

Code Item Sensitivity Analytical Range

DKO076 Insulin 0,25 μIU/mL 3,0 – 200,0 μIU/mLDKO077 C-Peptide 0,01 ng/mL 0,2 – 10,0 ng/mLDKO128 Fetuin A 0,04 ng/mL 6,5 – 208,0 ng/mLDKO147 HbA1c ELISA soon availableDKO152 HbA1c Normal Control soon availableDKO153 HbA1c Abnormal Control soon availableDKO187 HbA1c Calibrator Set soon available


DKO082 Anti-GAD 92,3 % 88,6 %DKO083 IAA 60,0 % 90,0 %DKO084 Anti-IA2 65,3 % 90,0 %DKO123 ZnT8 Ab 68,0 % 99,0 %

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TUMOR MARKERS

Immunoenzymatic assay (ELISA) for the quantitative determination on serum or plasma.Direct method on microplate (96 breakable wells), TMB


DKO012 AFP 0,35 ng/mL 5,0 – 200,0 ng/mLDKO051 CEA 0,11 ng/mL 5,0 – 250,0 ng/mLDKO054 CA 125 1,7 U/mL 5,0 – 250,0 U/mLDKO055 CA 15-3 0,5 U/mL 15,0 – 240 U/mLDKO056 CA 19-9 0,18 U/mL 15,0 – 240 U/mLDKO057* PSA 0,5 ng/mL 5,5 – 100 ng/mLDKO064* Free PSA 0,052 ng/mL 0,5 – 10,0 ng/mLDKO073 hNSE 0,19 ng/mL 4,0 – 100 ng/mLDKO074 S100 B 2,0 pg/mL 10,0 – 5000,0 pg/mLDKO137 Total PSA 0,2 ng/mL 1,56 – 25 ng/mLDKO138 Free PSA 0,1 ng/mL 0,75 – 12,0 ng/mLDKO183* Free B-HCG 0,026 mIU/mL 2,0 – 50 mIU/mLDKO184* PAPP-A 34,0 mIU/L 100,00 – 10.000 mIU/LDKO189 CHROMOGRANIN 12,4 µg/L 50,0 – 1500 µg/L

* RUO: For research use only

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SALIVARY BIOMARKERS

Immunoenzymatic assay (ELISA) for the quantitative determination in saliva.Competitive method on microplate (96 breakable wells), TMB

Steroid Hormones in Saliva


DKO020 Cortisol Saliva 0,12 ng/mL 0,5 – 100 ng/mLDKO021 Testosterone Saliva 3,0 pg/mL 10,0 – 1000 pg/mLDKO022 Estradiol Saliva 0,5 pg/mL 1,0 – 100 pg/mLDKO023 17OH-Progesterone Saliva 0,05 ng/mL 0,2 – 20,0 ng/mLDKO024 DHEA-S Saliva 0,05 ng/mL 0,2 – 12 ng/mLDKO025 Progesterone Saliva 3,8 pg/mL 10,0 – 5000 pg/mLDKO026 Estriol Saliva < 2,0 pg/mL 2,5 – 4000 pg/mLDKO027 Androstenedione Saliva 5,0 pg/mL 20,0 – 1000 pg/mLDKO178 Estriol Saliva HS 1,48 pg/mL 2,0 -315 pg/mL

Saliva Miscellaneous


DKO078 Salivary IgA 0,5 µg/mL 6,9 – 400 µg/mLDKO075* a-Amylase 2,5 U/mL 2,5 – 400 U/mLDKO063 Saliva Collector Devices 100 testsDKO120 Salivette™ ( Sarsted ) 100 testsDKO067 Saliva Control 1 x 3 x 2 mLDKO177 Anti-tTG-IgA Saliva On request


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IMMUNOASSAY Unit

STEROID HORMONES

Among the most complete panel available on the market

since 1997, the Diametra steroid hormone menu represents the status of the art

• Well proven quality• Reagents ready to use • Shelf life over 15 months• Each product is CE marked.

• Same procedure for the whole panel and same common reagents:easy applica!on on the most popular microplate autoanalyzers.

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CONTROLS AND CALIBRATORS

Code Item

DKO067 Saliva Controls 1 x 3 x 2 mLDKO156 Diametra Hormone Control plus 1 x 3 x 3 mLDKO187 HBA1C Calibrator Set soon available

FERTILITY PROTEIC HORMONES



DKO009 LH 0,22 IU/mL 5,0 – 200 IU/mLDKO010 FSH 0,17 IU/mL 5,0 – 100 IU/mLDKO011 PROLACTIN 0,12 ng/mL 5,0 – 100 ng/mLDKO014 b-HCG 0,09 mIU/mL 1,0 – 400 mIU/mLDKO087 SHBG 0,2 nmol/mL 2,78 – 278 nmol/mL

STEROID HORMONES IN SERUM

Immunoenzymatic assay (ELISA) for the quantitative determination in serum or plasma.Competitive method on microplate (96 breakable wells), TMB


DKO001 Cortisol 2,44 ng/mL 10,0 – 500 ng/mLDKO002 Testosterone 0,07 ng/mL 0,2 – 16 ng/mLDKO003 Estradiol 8,7 pg/mL 20,0 – 2000 pg/mLDKO004 17 OH-Progesterone 0,09 ng/mL 0,2 – 19,2 ng/mLDKO005 DHEA-S 0,03 µg/mL 0,1 – 10 µg/mLDKO006 Progesterone 0,05 ng/mL 0,2 – 40 ng/mLDKO007 Free Estriol 0,03 ng/mL 0,15 – 40 ng/mLDKO008 Androstenedione 0,01 ng/mL 0,1 – 10 ng/mLDKO015 Free Testosterone 0,06 pg/mL 0,2 – 100 pg/mLDKO019 Total Estriol 0,22 ng/mL 2,0 – 200 ng/mLDKO053 Aldosterone 7,0 pg/mL 20 – 2000 pg/mLDKO124 DHEA 0,1 ng/mL 0,5 – 30 ng/mLDKO142 Free Testosterone 2G 0,04 pg/mL 0,2 -100 pg/mL

STEROID HORMONE IN URINE


DKO018 Urinary Cortisol 2,9 ng/mL 10 – 500 ng/mL

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THYROID MONITORING

Immunoenzymatic determination (ELISA) in serum or plasma.Direct sandwich or competitive method on microplate (96 breakable wells) T.M.B.


DKO013 TSH 0,01 mIU/L 0,2 – 20,0 mIU/LDKO037 FT3 0,05 pg/mL 0,4 – 18,0 pg/mLDKO038 FT4 0,05 ng/dl 0,3 – 7,0 ng/dlDKO044 T3 5,0 ng/dl 50,0 – 750,0 ng/dlDKO045 T4 0,4 μg/dl 2,0 – 25,0 μg/dlDKO048 Thyreoglobulin 0,44 ng/mL 2,0 – 250,0 ng/mL


DKO115 Anti TG 96,3 % 94,9 %DKO116 Anti TPO 94,0 % 92,9 %DKO085 TSH Receptor Ab 98,0 % >99,0 %DKO176 FAST TRAb 85,0 % 100 %

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INFECTIOUS DISEASES


Code Item Test principle/range Incubation time

DKI001 Epstein Barr Virus VCA IgA Quantitative 0,1 – 150 U/mL 60 + 30 + 20 minDKI002 Epstein Barr Virus VCA IgG Qualitative/semiquantitative 60 + 60 + 20 minDKI003 Epstein Barr Virus VCA IgM Qualitative/semiquantitative 60 + 60 + 20 minDKI004 Herpes simplex Virus Type 1 IgG Qualitative/semiquantitative 60 + 30 + 15 minDKI005 Herpes simplex Virus Type 1 IgM Qualitative/semiquantitative 60 + 30 + 15 minDKI006 Herpes simplex Virus Type 2 IgG Qualitative/semiquantitative 60 + 30 + 15 minDKI007 Herpes simplex Virus Type 2 IgM Qualitative/semiquantitative 60 + 30 + 15 minDKI008 Herpes simplex Virus Type 1+2 IgG Qualitative/semiquantitative 60 + 30 + 15 minDKI009 Herpes simplex Virus Type 1+2 IgM Qualitative/semiquantitative 60 + 30 + 15 minDKI010 Chagas (Trypanosoma cruzi) IgG Qualitative 30 + 30 + 30 minDKI011 Dengue Virus IgG Qualitative/semiquantitative 60 + 30 + 15 minDKI012 Dengue Virus IgM Qualitative/semiquantitative 60 + 30 + 15 minDKI013 Malaria Ab (IgG, IgM, IgA) Qualitative/semiquantitative 30 + 30 + 30 minDKI014* Chlamidia trachomatis IgA Qualitative 60 + 30 + 15 minDKI015* Chlamidia trachomatis IgG Qualitative 60 + 30 + 15 minDKI016* Chlamidia trachomatis IgM Qualitative 60 + 30 + 15 minDKI017 Helicobacter pylori IgG Qualitative/quantitative 0 – 150 DU/mL 60 + 30 + 15 minDKI018 Helicobacter pylori IgM Qualitative 30 + 30 + 20 minDKI019 Helicobacter pylori IgA Qualitative/quantitative 0 – 150 DU/mL 60 + 30 + 15 minDKI020 Helicobacter pylori Ag in stools Qualitative/quantitative 0 – 1 μg/mL 120 + 20 minDKI021 Helicobacter pylori Ag in stools extraction kitDKI022 HAV Antigen in stools Qualitative/semiquantitative 120 + 120 + 30 minDKI023 Treponema pallidum IgG Qualitative/semiquantitative 60 + 30 + 15 minDKI024 Treponema pallidum IgM Qualitative/semiquantitative 60 + 30 + 15 minDKI025 Treponema pallidum Screen Qualitative 60 + 30 + 15 minDKI026 Tetanus toxin (Antitoxin) IgG Quantitative 0,2 – 1 IU/mL 60 + 30 + 15 min


HYPERTENSION

Immunoenzymatic assay (ELISA) for the quantitative determination on serum or plasma.Method on microplate (96 breakable wells), TMB


DKO053 Aldosterone 7,0 pg/mL 20 – 2000 pg/mLDKO150 Renin 0,8 pg/mL 3,9-270 pg/mLDKO185 ACTH Soon available

CALCIUM METABOLISM



DKO146 25 OH Vitamin D 0,67 ng/mL 2,5 – 150 ng/mLDKO157 Intact PTH 1,57 pg/mL 7 - 210 pg/mLDKO188 Osteocalcin Soon available

CIRCULATING IMMUNOCOMPLEX

Immunoenzymatic determination of specific circulating immunocomplexes in plasma or serum


DKO016 CIC C1q 1 μg Equiv/mL 16,0 – 64,0 μg Equiv/mLDKO017 CIC C3d 1 μg Equiv/mL 16,0 – 64,0 μg Equiv/mLDKO040 CH50 0 – 100%

MISCELLANEOUS



DKO039 Ferritin 0,53 ng/mL 5,0 – 1000,0 ng/mLDKO050 HGH 0,1 μIU/mL 2,0 – 150,0 μIU/mLDKO060 IgE Total 0,27 IU/mL 5,0 – 400,0 IU/mLDKO148 Hb Total Urine (Microhaematuria) High sensitivity Soon availableDKO180 Troponin 1 0,03 ng/mL 1,0 – 30 ng/mLDKO186 IGF 1 Soon availableDKO181 Calcitonin 0,7 pg/mL 10 – 400 pg/mL

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contact us

Headquarter R & D and Manufacturing 20090 Segrate - Milano Italy 06038 SPELLO - Perugia Italy Via Garibaldi, 18 Via Pozzuolo, 14 phone +39.02.21.39.184 phone +39.0742.30.19.29 phone +39.02.26.92.15.95 phone +39.0742.24.851 fax +39.02.21.33.354 fax +39.0742.31.61.97

E mail: Customer service [email protected] Product Manager [email protected] Managing Director [email protected] President and Ceo [email protected]

www.diametra.com

SALES CONDITIONS

Prices and TermsPrices are in Euro, EX WORKS SPELLO - PERUGIA - ITALY unless differently agreed.Prices will be effective at the date of the order acknowledgment by DiaMetra.Goods will be delivered as per your instructions.Handling fees will be billed in the invoice.

Minimum Acceptable Order: Euro 250,00

Payment termsUnless otherwise agreed in writing, payment shall be made by cash in advance.Should the payment be made in whole or in part after delivery, the delivered products remain property of DiaMetrasrl until the payment obligations have been entirely fulfilled.

Claim and ReturnDiaMetra srl is committed to fulfill and ship out the orders promptly. If wrong deliveries or damage to the products do occur, please notify them to us immediately. If the purchaser fails to notify DiaMetra of such defects within 10 days, the products will be deemed in compliancewith the specifications.DiaMetra srl sole obligation is limited to the replacement of the products proven as defective.In no case DiaMetra shall be liable for indirect, incidental or consequential damages to the use of the products.Return of goods will not be accepted without prior written authorization by DiaMetra.

For any controversy or dispute arising out or related to the interpretation of the present general conditions and/orany contract connected there with, the competent court of MILANO, Italy will have exclusive jurisdiction.

the new r&d and manufacturing plant in spello • perugia ... diametra 2015.pdf · the new...

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