List of HIV diagnostics eligible to tender for procurement by WHO in 2011

Transcription

1 Since 1988, WHO has performed assessments of commercially available diagnostics for HIV, hepatitis B, hepatitis C and Chagas disease. Up to 2006, this process was called the WHO Test Kit Evaluation programme, it was the predecessor of the WHO Prequalification of Diagnostics Programme. Currently, products meeting the following product selection criteria are eligible to participate in the WHO process for establishing a long term agreement (LTA) for procurement by WHO through a request for proposal (RFP). The product selection criteria for HIV diagnostics are: Analyte EIAs Simplerapid assays HIV Sensitivity: % Specificity: 98% Sensitivity. 99% Specificity: 98% Inter-reader variability: 5% Invalid rate: 5% See web link to reports containing WHO Test Kit Evaluation programme data on Shelf life s supplied should have a long maximum shelf life upon manufacture, where possible. The guaranteed minimum shelf life upon delivery is negotiated as part of the bidding process (for this list, guaranteed shelf life for each product was submitted by manufacturer as part of the WHO bidding process through RFP). As a minimum, at least 6 months shelf life remaining should be guaranteed up upon delivery to country. For further information about this product list, contact by diagnostics@who.int

2 uaranteed Shelf Life HIV 2 Assay Antigen HIV SimpleRapid Assays Chembio Diagnostics 2 Stat-Pak (Medford, USA) HIV % 99.3% serum, 16 months 8 to 30 C (if Chembio Diagnostics 2 Stat-Pak Dipstick (Medford, USA) EY Laboratories InstantCHEK HIV 1+2 Rapid Test (SAR Hong Kong, PR China) HIV % % serum, % 97.6% serum, 16 months 8 to months -20 to 28 immuno-filtration recombinant protein C (if C (if Fujirebio Serodia HIV-12 (Tokyo, Japan) InTec s Advanced Quality HIV Rapid Test (Xiamen, China) ITP TC % % serum, % 98.8% serum, 9.6 months 2 to months 2 to 30 agglutination C (U-bottomed 96 well plate, plate mixer), D, E, C (if Inverness Medical Japan Determine TM HIV-12 SerumPlasma Assay If method, order Chase Buffer 7D22-11 EDTA Capillary Tubes 7D22-21 (Matsudo, Japan) 7D2343 % % 5 serum, 9.6 months 2 to 30 recombinant protein, synthetic peptide C (if Page 2 of 6 1 Results as obtained under the WHO Test Kit Evaluation programme which was the predecessor of the WHO Prequalification of Diagnostics programme. Data was generated using the WHO serum specimen panel, final sensitivity & final specificity values are shown. See web link to reports containing data on 2 Assays denoted as are capable of discrimination between HIV-1 and HIV-2, those denoted are not capable of discrimination 5 Results as obtained in WHO test kit evaluations using or oral fluid specimen panels NA Not Applicable

3 uaranteed Shelf Life HIV 2 Assay Format Antigen HIV SimpleRapid Assays Cont'd J Mitra & Co., India HIV Tridot (New Delhi, India) OraSure Technologies Inc OraQuick HIV-12 - Rapid HIV-12 Antibody Test If method, order Specimen Loops (Bangkok, Thailand) IR IR IR130 IR X X % 99.7% serum, % 99.2% serum, oral fluid, 12 months 8 months 2 to 30 immunofiltration E, C (if Orgenics Ltd DoubleCheckold &2 Whole Blood (Yavne, Israel) % 99.3% serum, 14.4 months 2 to 30 C (if D, Orgenics Ltd Immunocomb II & 2 BiSpot (Yavne, Israel) % 99.7% serum, 12 months immunodot D, E, Premier Medical Corp First Response -2-0 Card Test (Daman, India) I05FRC30 30 % % 5 serum, 23 months 4 to 30 C (if Qualpro Diagnostics Retrocheck &2 Core Diagnostics Core HIV 1&2 (Verna, India) HIV-150 HIV % 99.1% serum, 22 or 23 months 4 to 30 recombinant protein, C (if Page 3 of 6 1 Results as obtained under the WHO Test Kit Evaluation programme which was the predecessor of the WHO Prequalification of Diagnostics programme. Data was generated using the WHO serum specimen panel, final sensitivity & final specificity values are shown. See web link to reports containing data on 2 Assays denoted as are capable of discrimination between HIV-1 and HIV-2, those denoted are not capable of discrimination 5 Results as obtained in WHO test kit evaluations using or oral fluid specimen panels NA Not Applicable

4 uaranteed Shelf Life HIV 2 Assay Format Antigen HIV SimpleRapid Assays Cont'd Shanghai Kehua Diagnostic Kit for HIV (1+2) Antibody (Colloidal old) (Shanghai, PR China) KH-R % % serum, 15 months 4 to 30 recombinant protein, synthetic peptide C (if D, Trinity Biotech Uni-old HIV-1HIV-2 (Bray, Ireland) % &`% serum, 12 months 2 to 27 C (if Page 4 of 6 1 Results as obtained under the WHO Test Kit Evaluation programme which was the predecessor of the WHO Prequalification of Diagnostics programme. Data was generated using the WHO serum specimen panel, final sensitivity & final specificity values are shown. See web link to reports containing data on 2 Assays denoted as are capable of discrimination between HIV-1 and HIV-2, those denoted are not capable of discrimination 5 Results as obtained in WHO test kit evaluations using or oral fluid specimen panels NA Not Applicable

5 uaranteed Shelf Life HIV Antigen Wavelength 2 HIV EIAs AniLabsystems Ltd HIV EIA (Vantaa, Finland) % 99.4% serum, 10 months 4 to 8 synthetic peptides 450 nm A, B, C, D, E, F Shanghai Kehua ANTI- + 2 Antibodies ELISA Diagnostics Kit (Shanghai, PR China) KH-T % 98.3% serum, 10 months recombinant proteins, synthetic peptides nm A, B, C, D, E, F, Siemens Healthcare Diagnostics Enzygnost Anti-2 Plus OQFK135 OQFK215 2 x x 96 % 99.7% serum, 6 months O recombinant proteins nm A, B, C, D, E, F Enzygnost Supplementary Reagents (Marburg, ermany) OUVP United Biomedical UBI HIV-12 EIA (Hauppauge, USA) % % serum, 12 months synthetic peptides 490nm A, B, C, D, E, F Page 5 of 6 1 Results as obtained under the WHO Test Kit Evaluation programme which was the predecessor of the WHO Prequalification of Diagnostics programme. Data was generated using the WHO serum specimen panel, final sensitivity & final specificity values are shown. See web link to reports containing data on 2 Assays denoted as are capable of discrimination between HIV-1 and HIV-2, those denoted are not capable of discrimination 5 Results as obtained in WHO test kit evaluations using or oral fluid specimen panels NA Not Applicable

6 No. of Tests uaranteed Shelf Life Storage Temp ( C) HIV 2 Assay Format Antigen HIV Confirmatory Assays Bio-Rad Laboratories NEW LAV BLOT I NA NA serum, 4 months Western blot viral lysate D, E (Steenvoorde, France) Bio-Rad Laboratories NEW LAV BLOT II NA NA serum, 4 months Western blot viral lysate D, E (Steenvoorde, France) Bio-Rad Laboratories PEPTI-LAV NA NA serum, 4 months line immunoassay C, D, E (Steenvoorde, France) Innogenetics INNO-LIA TM HIV III SCORE NA NA serum, 12 months line immunoassay, C, D, E (hent, Belgium) MP Biomedicals HIV BLOT NA NA serum, 11 months Western blot viral lysate, synthetic peptide C, D, E (Illkirch, France) Page 6 of 6 1 Results as obtained under the WHO Test Kit Evaluation programme which was the predecessor of the WHO Prequalification of Diagnostics programme. Data was generated using the WHO serum specimen panel, final sensitivity & final specificity values are shown. See web link to reports containing data on 2 Assays denoted as are capable of discrimination between HIV-1 and HIV-2, those denoted are not capable of discrimination 5 Results as obtained in WHO test kit evaluations using or oral fluid specimen panels NA Not Applicable