WHO list of prequalified in vitro diagnostic products
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1 WHO list of in vitro diagnostic products 2016 HIV EIA AiD anti-hiv 1+2 ELISA WI-4396 and WI HIV RDT Rapid Test for Antibody to Human Immunodeficiency Virus (HIV) (Colloidal Gold Device) WJ-1810, WJ-1810E, WJ and WJ-1850E 2016 Malaria RDT SD BIOLINE Malaria Ag P.f. POCT* 05FK53 B30166, B39101 B39102, B25697, B25698, B23536, 2015 B23538, B23533, Aquios CL flow cytometer B23534, B23535, B25700, B23502 Beijing Wantai Biological Pharmacy Enterprise Co. Beijing Wantai Biological Pharmacy Enterprise Co. Beckman Coulter Life Sciences Beijing, China Beijing, China Miami, FL, USA (instrument site) and Hialeah, FL, USA (reagent site) 96T/kit 480T/kit 10T/kit w/accessories 10T/kit 25 x 1Test/kit 2015 HIV/Syphilis SD BIOLINE HIV/Syphilis Duo 06FK30 and 06FK Malaria RDT SD BIOLINE Malaria Ag P.f/P.v 05FK Malaria RDT SD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK HCV EIA INNO-LIA HCV Score Fujirebio Europe NV Zwijnaarde, Belgium 20T/kit 2015 HIV EIA DS-EIA-HIV-AGAB-SCREEN I-1654, I-1652 and I-1656 RPC Diagnostics Systems Nizhniy Novgorod, Russia 96T/1 plate; 192T/2 plates; 480 T/5 plates Page 1 of 9
2 WHO list of in vitro diagnostic products 2015 HCV EIA Murex anti-hcv (version 4.0) 7F51-01 and 7F Malaria RDT CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO 2015 Malaria RDT CareStart Malaria HRP2 (Pf) 2015 Malaria RDT CareStart Malaria HRP2/pLDH (Pf/Pv) COMBO RMRM and RMRM G0131) RMOM and RMOM G0141) RMVM and RMVM G0161) DiaSorin South Africa (Pty) Ltd. Kyalami, South Africa Access Bio, Somerset NJ, USA Access Bio, Somerset NJ, USA Access Bio, Somerset NJ, USA 96T/kit 480T/kit Page 2 of 9
3 WHO list of in vitro diagnostic products 2015 Malaria RDT CareStart Malaria HRP2/pLDH (Pf) 2015 Malaria RDT CareStart Malaria pldh (PAN) RMPM and RMPM G0181) RMNM and RMNM G0111) Access Bio, Somerset NJ, USA Access Bio, Somerset NJ, USA 2015 HIV Supplemental Assay INNO-Lia HIV I/II Score Fujirebio Europe N.V. Ghent, Belgium 220 Strip Kit 2015 HCV EIA Bioelisa HCV and Biokit S.A. Barcelona, Spain 96T/1 plate; 480T/5 plates 2015 HIV EIA Murex HIV Ag/Ab Combination 7G79-09 (GE41, 96 wells) and 7G79-11 (GE42, 480 wells) DiaSorin S.p.A UK Branch Dartford, UK 96T/kit; 480T/kit 2015 HIV EIA Bioelisa HIV 1+2 Ag/Ab and Biokit S.A. Barcelona, Spain 96T/1 plate; 480T/5 plates 2015 Malaria RDT First Response Malaria Ag P. falciparum (HRP2) Card Test I13FRC25and I13FRC30 Premier Medical Corporation Nani Daman and Sarigam, India ; 30T/kit Page 3 of 9
4 WHO list of in vitro diagnostic products COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 96) , , , , , , , and , , , , , , and HIV RDT SURE CHECK HIV 1/2 Assay HIV HBsAg EIA 2014 Malaria RDT 2014 Malaria RDT Murex HBsAg Version 3 with Murex HBsAg Confirmatory Version 3 ParaHIT f Ver. 1.0 Rapid Test for P.falciparum Malaria Dipstick ParaHIT f Ver. 1.0 Rapid Test for P.falciparum Malaria Device 9F80-01, 9F80-05 and 2G IC103-10, 55IC103-25, and 55IC IC104-10, 55IC and, 55IC Roche Molecular Systems, Roche Diagnostics GmbH Chembio Diagnostic Systems, DiaSorin S.p.A UK Branch ARKRAY Healthcare Pvt. Ltd. ARKRAY Healthcare Pvt. Ltd. Branchburg, New Jersey, USA Mannheim, Germany Medford, NY, USA Dartford, UK Sachin (Surat), India Sachin (Surat), India 48T/kit 48T/kit 96T/kit; 480T/kit 10T/kit, and 10T/kit, and 2014 HIV RDT ImmunoComb II HIV 1&2 BiSpot Orgenics Ltd. Yavne, Israel 36T/kit Page 4 of 9
5 WHO list of in vitro diagnostic products 2014 BD FACSPresto Near-Patient Counter with BD %/Hb Cartridge and BD FACSPresto Cartridges Kit , and Becton, Dickinson and Company, BD Biosciences San Jose, California, USA : instrument : catridge (100/box) and : pipette (100/box) 2014 HIV RDT ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device IHI-T402 ABON Biopharm (Hangzhou) Co. Ltd. Hangzhou, PR China 40T/kit 2013 HIV RDT VIKIA HIV 1/ biomérieux SA Marcy L Etoile, France 2013 HIV RDT INSTI HIV-1/HIV-2 Antibody Test , , , and Malaria RDT SD BIOLINE Malaria Ag P.f/Pan 05FK Abbott RealTim e HIV-1 Qualitative (Manual) 4N66-90, 4N66-80, 6K12-24, 9K15-01, 4N66-01 and 4N66-66 (optional) BioLytical Laboratories, Richmond, British Columbia, Canada 1T/kit; 24T/kit; 24T/kit with support materials; 48T/kit; 48T/kit with support materials 96T/kit; 4x24T pack 2013 Abbott RealTim e HIV-1 Qualitative (m 2000sp) 4N66-90, 9K14-02, 9K15-01, 4N66-80, 4N66-01, 6K12-24 and 4N66-66 (optional) 96T/kit; 4x24T pack Page 5 of 9
6 WHO list of in vitro diagnostic products 2013 HIV RDT SD BIOLINE HIV-1/ FK16 and 03FK10 ; 30T/kit 2013 HIV EIA Genscreen ULTRA HIV Ag-Ab 72386; Bio-Rad Marnes La Coquette, France 96T/1 plate; 480T/5 plates 2013 HIV RDT SD Bioline HIV Ag/Ab Combo 03FK35; 03FK30 ; 30T/kit HIV RDT Uni-Gold HIV , N and E Trinity Biotech Manufacturing Ltd. Bray, Ireland 20 Test Devices, Wash Reagent (2 ml) and 20 Disposable Pipettes Pima Test BD FACSCount Instrument System with FACSCount Control Kit and BD FACSCount Reagent Kit (Absolute +, CD8+, and CD3+ Counts) and ; and , and Alere GmbH Becton, Dickinson and Company, BD Biosciences Jena, Germany San Jose, CA, USA 25 cartridges/kit and instrument; 100 cartridges/kit and instrument : instrument system : 25T /kit : BD FACSCount Instrument System with FACSCount Control Kit and BD FACSCount Reagent Kit (Absolute and Percentage + Counts) , and Becton, Dickinson and Company, BD Biosciences San Jose, CA, USA : instrument system : : Page 6 of 9
7 WHO list of in vitro diagnostic products COBAS AmpliPrep/COBAS TaqMan HIV- 1 Test, version 2.0 (TaqMan 48) COBAS AmpliPrep/COBAS TaqMan HIV- 1 Test, version 2.0 (TaqMan 96) , , , , , and , , , , , , and HIV RDT Alere Determine HIV-1/2 Ag/Ab Combo 7D2643; 7D2243 Roche Diagnostics GmbH Roche Molecular Systems Alere Medical Co. Ltd. Mannheim, Germany Branchburg, NJ, USA Matsudo-shi, Chiba-ken, Japan : 48T/kit : 5.1 liters : 48T/kit : 5.1 liters 10 cards (10T/card) and chase buffer (1 bottle) VERSANT HIV-1 RNA 1.0 Assay (kpcr) , , , and Siemens Healthcare Diagnostics Tarrytown NY, USA 96T/kit HIV RDT HIV 1/2 STAT-PAK HIV101 Chembio Diagnostic Systems Medford, NY, USA 1Tx20/kit Page 7 of 9
8 WHO list of in vitro diagnostic products NucliSENS EasyQ HIV-1 v2.0 (Automated) ,280130, , ,280133, , , and biomérieux SA Marcy L Etoile, France , , , and : 4x1L : 48 T/kit NucliSENS EasyQ HIV-1 v2.0 (Semi- Automated) , , , , and HIV RDT Alere Determine HIV-1/2 7D2342; 7D2343 HIV RDT HIV 1/2 STAT-PAK Dipstick HIV303 Abbott RealTime HIV-1 (Manual) Abbott RealTim e HIV-1 (m 2000sp) 2G31 (2G31-90, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-01, 04J70-24 and 04J G31 (2G31-90, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-01, 04J70-24, 04J71-93 and 9K14-02 biomérieux SA Marcy L Etoile, France Alere Medical Co. Ltd. Chembio Diagnostic Systems Matsudo-shi, Chiba-ken, Japan Medford, NY, USA and : 48T/kit, : 48 T/kit 20T/kit; 100T/kit 1Tx30/kit 2G31-90: 96T/kit (4x24T); 2G31-80: 8 runs; 2G31-70: 4 calibration runs (1/6 months); 04J70-24: 96T/kit 2G31-90: 96T/kit (4x24T); 2G31-80: 8 runs; 2G31-70: 4 calibration runs (1/6 months); 04J70-24: 96T/kit Page 8 of 9
9 WHO list of in vitro diagnostic products Abbott RealTim e HIV-1 (m 24sp) 3N06-01, 2G31(2G31-90, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-01, 04J70-24 and 04J Malaria RDT SD BIOLINE Malaria Ag P.f 05FK50 * Product originally in 2010 and amended to include an additional product code. End of document Giheung-ku, Republic of 2G31-90: 96T/kit (4x24T); 2G31-80: 8 runs; 2G31-70: 4 calibration runs (1/6 months); 04J70-24: 96T/kit Page 9 of 9
Initial sensitivity: 100% Final specificity: 98% Initial sensitivity: 99%
List of diagnostics eligible to tender for procurement by WHO in 2014 (including WHO prequalified diagnostics) Since 1988, WHO has performed assessments of commercially available diagnostics for HIV, hepatitis
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