WHO list of prequalified in vitro diagnostic products
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1 WHO list of in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 21 December 2016 Year 2016 HIV RDT Diagnostic kit for HIV (1+2) antibody (colloidal gold) V2 R C-2, KH-R-02, A- GOLD-01 Shanghai Kehua Bioengineering Co., Ltd Shanghai, PR China 2016 HCV RDT SD BIOLINE HCV 02FK10 30T/kit 2016 HBsAg EIA bioelisa HBsAg , Biokit S.A. Llicà d`amunt, Spain 2016 HIV RDT First Response HIV Card Test I05FRC100, I05FRC60, I05FRC30, I05FRC05 Premier Medical Corporation Nani Daman, Daman, India and Sarigam, Gujarat, India 100T/kit; 60T/kit; 30T/kit; 5T/kit; 2016 HIV RDT Alere HIV Combo 7D2842, 7D2843, 7D2843SET Alere Medical Co. Ltd. Matsudo-shi, Chiba-ken, Japan 2016 HIV NAT Xpert HIV-1 Qual Assay GXHIV-QA-CE-10 Cepheid AB Solna, Sweden 2016 HIV NAT Alere q HIV-1/2 Detect , , Alere Jena, Germany 20T/kit; 100T/kit; 100T/kit 10 cartridges/kit and instrument 10 cartridges/kit and instrument; 50 cartridges/kit and instrument 2016 HIV RDT DPP HIV 1/2 Assay Systems 20T/kit 2016 HIV RDT OraQuick HIV 1/2 Rapid Antibody Test 5x4-0010, 5x OraSure, Bethlehem, USA and Petchabun, Thailand 100T/kit 500T/kit 2016 HBsAg EIA DS-EIA-HBsAg-0,01 В-1254, В-1252, В-1255, В-1256, В-231 RPC Diagnostics Systems Nizhniy Novgorod, Russia 192T/kit 96T or 48T (if confirmation)/kit
2 2016 HIV Supplemental Assay 2016 HBsAg EIA 2016 HIV EIA MP Diagnostics HIV Blot , Enzygnost HBsAg 6.0 and supplementary reagents kit for Enzygnost /TMB Enzygnost HIV Integral 4 and Supplementary reagents kit for Enzygnost /TMB OPFM03, OPFM05, OPFM05(Q), OUVP17 OPKR03, OPKR05, OPKR05(Q), OUVP17 MP Biomedicals Asia Pacific Pte.Ltd. Siemens Healthcare Diagnostics Products Siemens Healthcare Diagnostics Products Singapore, Singapore Marburg, Germany Marburg, Germany 18T/kit 36T/kit 960T/kit 960T/kit (for higherthroughput) 960T/kit 960T/kit (for higherthroughput) 2016 HIV EIA AiD anti-hiv 1+2 ELISA WI-4396, WI Beijing Wantai Biological Pharmacy Enterprise Co. Beijing, China 2016 HIV RDT Rapid Test for Antibody to Human WJ-1810, WJ-1810E, WJ- Immunodeficiency Virus (HIV)(Colloidal 1850, WJ-1850E Gold Device) Beijing Wantai Biological Pharmacy Enterprise Co. Beijing, China 10T/kit w/accessories 10T/kit 2015 Aquios CL flow cytometer B30166, B39101 B39102, B25697, B25698, B23536, B23538, B23533, B23534, B23535, B25700, B23502 Beckman Coulter Life Sciences Miami, FL, USA (instrument site) and Hialeah, FL, USA (reagent site) 2015 HIV/Syphilis SD BIOLINE HIV/Syphilis Duo 06FK30, 06FK Malaria RDT SD BIOLINE Malaria Ag P.f/P.v 05FK80, 05FK81, 05FK82, 05FK83, 05FK86, 05FK87 25X1T/kit 2015 Malaria RDT SD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK90, 05FKFK93, 05FK91, 05FK092 25X1T/kit 2015 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, I-1656 RPC Diagnostics Systems Nizhniy Novgorod, Russia 96T/1 plate; 192T/2 plates; 480 T/5 plates
3 2015 HCV EIA Murex anti-hcv (version 4.0) 7F51-01, 7F51-02 DiaSorin South Africa (Pty) Ltd. Kyalami, South Africa 2015 Malaria RDT CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO RMRM-02571, RMRM G0131); RMRU and RMRU Access Bio, Somerset NJ, USA 40x1T/kit 2015 Malaria RDT CareStart Malaria HRP2 (Pf) RMOM-02571, RMOM G0141); RMOU and RMOU Access Bio, Somerset NJ, USA 40x1T/kit 2015 Malaria RDT CareStart Malaria HRP2/pLDH (Pf/Pv) COMBO 2015 Malaria RDT CareStart Malaria HRP2/pLDH (Pf) 2015 Malaria RDT CareStart Malaria pldh (PAN) RMVM-02571, RMVM G0161) RMPM-02571, RMPM G0181) RMNM-02571, RMNM G0111) Access Bio, Somerset NJ, USA 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 , Biokit S.A. Barcelona, Spain 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 2015 HIV EIA Bioelisa HIV 1+2 Ag/Ab , Biokit S.A. Barcelona, Spain 2015 Malaria RDT First Response Malaria Ag P. falciparum (HRP2) Card Test I13FRC25, I13FRC30 Premier Medical Corporation Nani Daman and Sarigam, India ; 30T/kit
4 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) , , , , , , , , Roche Molecular Systems, Roche Diagnostics Branchburg, New Jersey, USA Mannheim, Germany 2014 HIV RDT SURE CHECK HIV 1/2 Assay HIV201 Systems, 2014 HBsAg EIA Murex HBsAg Version 3 with Murex HBsAg Confirmatory Version 3 9F80-01, 9F80-05, 2G27-01 DiaSorin S.p.A UK Branch Dartford, UK ; 2014 Malaria RDT ParaHIT f Ver. 1.0 Rapid Test for P.falciparum Malaria Dipstick 55IC103-10, 55IC103-25, and 55IC ARKRAY Healthcare Pvt. Ltd. Sachin (Surat), India 10T/kit, and 2014 Malaria RDT ParaHIT f Ver. 1.0 Rapid Test for P.falciparum Malaria Device 55IC104-10, 55IC and, 55IC ARKRAY Healthcare Pvt. Ltd. Sachin (Surat), India 10T/kit, and 2014 BD FACSPresto Near-Patient Counter with BD %/Hb Cartridge and BD FACSPresto Cartridges Kit , , Becton, Dickinson and Company, BD Biosciences San Jose, California, USA Singapore, Singapore : 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-T402W ABON Biopharm (Hangzhou) Co. Ltd. Hangzhou, PR China 40T/kit 2013 HIV RDT VIKIA HIV 1/ biomérieux SA Marcy L Etoile, France
5 2013 HIV RDT INSTI HIV-1/HIV-2 Antibody Test , , , , BioLytical Laboratories, Richmond, British Columbia, Canada 1T/kit; 24T/kit; 24T/kit with support materials; ; with support materials 2013 Malaria RDT SD BIOLINE Malaria Ag P.f/Pan SD BIOLINE Malaria Ag P.f/Pan (POCT) 05FK60, 05FK61, 05FK62, 05FK63, 1T/kit 2013 Abbott RealTime HIV-1 Qualitative (Manual) 4N66-90, 4N66-80, 6K12-24, 9K15-01, 4N66-01, 4N66-66 (optional) 4x24T pack 2013 Abbott RealTime HIV-1 Qualitative (m 2000sp) 4N66-90, 9K14-02, 9K15-01, 4N66-80, 4N66-01, 6K12-24, 4N66-66 (optional) 4x24T pack 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 2013 HIV RDT SD Bioline HIV Ag/Ab Combo 03FK35, 03FK30 30T/kit HIV RDT Uni-Gold HIV , N, E Trinity Biotech Manufacturing Ltd. Bray, Ireland 20T/kit Pima Test and ; and Alere Jena, Germany 25 cartridges/kit and instrument; 100 cartridges/kit and instrument BD FACSCount Instrument System with FACSCount Control Kit and BD FACSCount Reagent Kit (Absolute +, CD8+, and CD3+ Counts) , , Becton, Dickinson and Company, BD Biosciences San Jose, CA, USA : instrument system : 25T /kit :
6 BD FACSCount Instrument System with FACSCount Control Kit and BD FACSCount Reagent Kit (Absolute and Percentage + Counts) , , Becton, Dickinson and Company, BD Biosciences San Jose, CA, USA and Cayey, Puerto Rico : instrument system : : COBAS AmpliPrep/COBAS TaqMan HIV- 1 Test, version 2.0 (TaqMan 48) COBAS AmpliPrep/COBAS TaqMan HIV- 1 Test, version 2.0 (TaqMan 96) , , , , , , , Roche Diagnostics Roche Molecular Systems Mannheim, Germany Branchburg, NJ, USA : : 5.1 liters : : 5.1 liters VERSANT HIV-1 RNA 1.0 Assay (kpcr) , , , and Siemens Healthcare Diagnostics Tarrytown NY, USA HIV RDT HIV 1/2 STAT-PAK HIV101 Systems 20T/kit NucliSENS EasyQ HIV-1 v2.0 (Automated) ,280130, , ,280133, , ,200309, biomérieux SA Marcy L Etoile, France , , , and : 4x1L : 48 T/kit NucliSENS EasyQ HIV-1 v2.0 (Semi- Automated) HIV RDT Alere Determine HIV-1/ , , , , and D2342, 7D2343, 7D2343SET HIV RDT HIV 1/2 STAT-PAK Dipstick HIV303 biomérieux SA Marcy L Etoile, France Alere Medical Co. Ltd. Systems Matsudo-shi, Chiba-ken, Japan and :, : 48 T/kit 20T/kit; 100T/kit; 100T/kit 1Tx30/kit
7 Abbott RealTime HIV-1 (Manual) 2G31 (2G31-90, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-01, 04J70-24, 04J G31-90: (4x24T); 2G31-80: 8 runs; 2G31-70: 4 calibration runs (1/6 months); 04J70-24: Abbott RealTim e HIV-1 (m 2000sp) 2G31 (2G31-90 or 2G31-010, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-01, 04J70-24, 04J71-93, 9K G31-90: (4x24T) or 2G (4x24T); 2G31-80: 8 runs; 2G31-70: 4 calibration runs (1/6 months); 04J70-24: Abbott RealTim e HIV-1 (m 24sp) 3N06-01, 2G31(2G31-90, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-01, 04J70-24, 04J G31-90: (4x24T); 2G31-80: 8 runs; 2G31-70: 4 calibration runs (1/6 months); 04J70-24: 2010 Malaria RDT SD BIOLINE Malaria Ag P.f SD BIOLINE Malaria Ag P.f. (POCT) 05FK50, 05FK51, 05FK52, 05FK53 Giheung-ku, Republic of, 1T/kit * Product originally in 2010 and amended in 2016 to include an additional product code. End of document
WHO list of prequalified in vitro diagnostic products
WHO list of prequalified in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 17 March 2017 Year
WHO list of prequalified in vitro diagnostic products
WHO list of in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 8 April 2016 Year 2016 HIV RDT OraQuick
WHO list of prequalified in vitro diagnostic products
WHO list of prequalified in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 22 December Year prequalified
WHO list of prequalified in vitro diagnostic products
: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2018 CD4 Muse Auto CD4/CD4% kit MCA100101, MCA500101, MCA1XK101 EMD Millipore Corporation
WHO list of prequalified in vitro diagnostic products
2018 CD4 CyFlow Counter System with CD4 easy count kit and CD4% easy count kit CY-S-3022, 05-8401, 05-8405 ed Sysmex Partec GmbH Arndtstr. 11a-b, 02826 Görlitz, Germany; and Exbio Praha a.s., Nad Safinou
Initial sensitivity: 99% Initial sensitivity: 100% Final specificity: 98% Final specificity: 98%
List of in vitro diagnostics eligible to tender for procurement by WHO in 2016 (including WHO prequalified in vitro diagnostics) Since 1988, WHO has performed assessments of commercially available diagnostics
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
For further information about this list including pricing, contact by Sensitivity: 99%
List of diagnostics eligible to tender for procurement by WHO in 2013 (including WHO prequalified diagnostics) Since 1988, WHO has performed assessments of commercially available diagnostics for HIV, hepatitis
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