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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,

1 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 B, hepatitis C and Chagas disease. Previously, this process was called the WHO Test Kit Evaluation programme, it was the predecessor of the WHO Prequalification of Diagnostics Programme. Currently, products that meets 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). Performance acceptance criteria for product selection criteria of serology assays are: Analyte EIAs Simple/rapid assays HIV Sensitivity: 100% Specificity: 98% Sensitivity: 99% Specificity: 98% Inter-reader variability: 5% Invalid rate: 5% HCV Sensitivity: 100% Specificity: 98% HBsAg Sensitivity: 100% Specificity: 98% Sensitivity: 98% Specificity: 97% Inter-reader variability: 5% Invalid rate: 5% Sensitivity: 100% Specificity: 98% Inter-reader variability: 5% Invalid rate: 5% Products that have been prequalified by the WHO Prequalification of Diagnostics programme are also eligible for procurement. During this transition period, products that were previously evaluated by the WHO Test Kit Evaluation programme and found to meet the product selection criteria will still be considered eligible for procurement. In the future, successful WHO prequalification will become the sole determinant of eligibility for procurement by WHO. See web address for reports containing WHO Test Kit Evaluation programme data on ics_laboratory/publications/evaluations/en/index.html See web address for WHO Prequalification of Diagnostics Public Reports on ics_laboratory/evaluations/pq_list/en/index.html Shelf life Products 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). For further information about this list including pricing, contact by diagnostics@who.int

2 (Country of manufacture) Product code No. of tests Sensitivity Specificity Shelf life/ storage Detection Specimen Comments HIV Simple Assays/Rapid Diagnostic Tests (RDTs) Alere Medical Japan Alere Determine (Matsudo, Japan) 7D2342 7D % 99.4% 12 months/ 2 to 30 C If whole : must order chase buffer 7D2211 (2.5ml), optional: EDTA capillary tubes 7D2222, lancets, alcohol swabs. If serum/plasma: requires precision pipette plus tips _0033_013_00_public_ report_final.pdf Alere Medical Japan Alere Determine Ag/Ab Combo (Matsudo, Japan) 7D % 98.8% 12 months/ 2 to 30 C and HIV-1 p24 antigen If whole : must order chase buffer 7D2211 (2.5 ml), optional: EDTA capillary tubes 7D2222, lancets, alcohol swabs. If serum/plasma: requires precision pipette plus tips _0034_013_00_final_p ublic_report_version2.pdf Chembio Diagnostic Systems, Inc. HIV 1/2 STAT-PAK (Medford, USA) Chembio Diagnostic Systems, Inc. HIV 1/2 STAT-PAK Dipstick (Medford, USA) HIV % 100% 24 months/ 8 to 30 C HIV % 99.7% 24 months/ 8 to 30 C If whole : lancets, alcohol swabs. HIV Test Kit Controls HIV104 available. If whole : lancets, alcohol swabs. If alternate procedure: must order sample tubes and tube rack _0007_006_00_public_ report_final_v1.pdf 11125_0008_006_00_public_ report_final.pdf EY Laboratories InstantCHEK HIV 1+2 Rapid Test (SAR Hong Kong, PR China) % 97.6% 12 months/ -20 to 28 C If whole : lancets, alcohol swabs.

3 (Country of manufacture) Product code No. of tests Sensitivity Specificity Shelf life/ storage Detection Specimen Comments HIV Simple Assays/Rapid Diagnostic Tests (RDTs) Fujirebio Serodia (Tokyo, Japan) % 100% 9.6 months/ 2 to 10 C Discrimination between HIV-1 and HIV-2 plasma Must order U-bottomed 96 well plate. Requires precision pipette plus tips. Optional: plate mixer InTec Products Advanced Quality HIV Rapid Test (Xiamen, PR China) ITP TC % 98.8% 18 months/ 2 to 30 C If whole : lancets, alcohol swabs. J Mitra & Co., India HIV Tridot (New Delhi, India) OraSure Technologies Inc OraQuick - Rapid HIV- 1/2 Antibody Test (Bangkok, Thailand) IR IR IR IR X X % 99.7% 12 months/ 100% 99.2% 8 months/ 2 to 30 C Discrimination between HIV-1 and HIV-2 plasma, oral fluid If whole : must order specimen loops , lancets, alcohol swabs. Orgenics Ltd Immunocomb II HIV 1 & 2 Bispot (Yavne, Israel) % 99.1% 12 months/ Discrimination between HIV-1 and HIV-2 plasma Requires precision pipette plus tips. Page 3 of 16 Not Applicable

4 (Country of manufacture) Product code No. of tests Sensitivity Specificity Shelf life/ storage Detection Specimen Comments HIV Simple Assays/Rapid Diagnostic Tests (RDTs) Premier Medical Corp First Response HIV Card Test (Daman, India) Shanghai Kehua Diagnostic Kit for HIV (1+2) Antibody (Colloidal Gold) (Shanghai, PR China) I05FRC % 98.8% 23 months/ 4 to 30 C KH-R % 100% 15 months/ 4 to 30 C Discrimination between HIV-1 and HIV-2 detection,, If whole : lancets, alcohol swabs. If whole : lancets, alcohol swabs. Requires precision pipette plus tips. Standard Diagnostics SD Bioline 3.0 (Yongin-si, Korea) Standard Diagnostics SD Bioline HIV Ag/Ab Combo (Yongin-si, Korea) Trinity Biotech Uni-Gold HIV (Bray, Ireland) 03FK16 03FK10 03FK35 03FK , N, E % 99.9% 24 months/ 1 to 30 C 100% 99.1% 18 months/ 1 to 30 C % 99.9% 12 months/ 2 to 27 C Discrimination between HIV-1 and HIV-2 and HIV-1 p24 antigen detection, If 03FK10 and for whole, required lancets, capillary tubes, alcohol swabs. If 03FK30 and for whole, required lancets, capillary tubes, alcohol swabs. If whole : lancets, alcohol swabs. ostics_laboratory/evaluati ons/130528_0027_012_00 _public_report_final_v2.p df 30322_0069_012_00_public_ report_final_v1.pdf 21213_ _public_report_v1.pdf Page 4 of 16 Not Applicable

5 (Country of manufacture) Product code No. of tests Sensitivity Specificity Shelf life/ storage Detection Wavelength Comments HIV Enzyme Immunoassays (EIA) AniLabsystems Ltd HIV EIA (Vantaa, Finland) % 99.4% 10 months/ 4 to 8 C detection 450 nm BioRad Genscreen ULTRA HIV Ag-Ab (Steenvoorde, France) % 99.2% 18 months/ and HIV-1 p24 antigen 450/ nm 30408_ _public_report_final_v1.pd f Shanghai Kehua ANTI-HIV Antibodies ELISA Diagnostics Kit (Shanghai, PR China) KH-T % 98.3% 10 months/ detection 450/ 620 nm Siemens Healthcare Diagnostics Enzygnost Anti-HIV 1/2 Plus Enzygnost Supplementary Reagents (Marburg, Germany) United Biomedical UBI EIA (Hauppauge, USA) OQFK135 OQFK215 2 x x % 99.7% 6 months/ OUVP % 100% 12 months/ detection detection 450/ 650 nm 490nm Under obsolescence plan Page 5 of 16 Not Applicable

6 (Country of manufacture) Product code No. of tests Sensitivity Specificity Shelf life/ storage Detection Format Comments HIV Supplemental Assays Bio-Rad Laboratories NEW LAV BLOT I (Steenvoorde, France) months/ HIV-1 Western blot/ viral lysate Requires precision pipette plus tips and other consumables. Bio-Rad Laboratories NEW LAV BLOT II (Steenvoorde, France) months/ HIV -2 Western blot/ viral lysate Requires precision pipette plus tips and other consumables. Bio-Rad Laboratories PEPTI-LAV 1-2 (Steenvoorde, France) months/ Discrimination between HIV-1 andhiv- 2 line immunoassay / synthetic peptides Requires precision pipette plus tips and other consumables. Innogenetics INNO-LIA TM HIV I/II SCORE (Ghent, Belgium) MP Biomedicals HIV BLOT 2.2 (Singapore, Singapore) months/ months/ Discrimination between HIV-1 and HIV-2 Discrimination between HIV-1 and HIV-2 line immunoassay / recombinant proteins, synthetic peptides Western blot/ viral lysate, synthetic peptide Requires precision pipette plus tips and other consumables. Requires precision pipette plus tips and other consumables. Page 6 of 16 Not Applicable

7 (Country of manufacture) HCV Rapid Diagnostic Tests (RDTs) J Mitra & Co HCV TriDot 4th generation (New Delhi, India) Span Diagnostics Signal HCV Flow Through (Udhna, India) HCV Enzyme Immunoassays (EIA) BioRad Laboratories Monolisa anti-hcv PLUS version 2 (Steenvoorde, France) Innogenetics INNOTEST HCV Ab IV (Ghent, Belgium) Ortho-Clinical Diagnostics HCV 3.0 Enhanced SAVe ELISA (USA) HCV Supplemental Assays Innogenetics INNO-LIA HCV Score (Ghent, Belgium) Product code No. of tests HC HC Sensitivity Specificity Shelf life/ storage 100% 98.9% 12 months/ 25972A % 98.9% 10 months/ months/ 100% 100% 10 months/ 7.2 months/ months/ Page 7 of 16 Not Applicable Detection HCV HCV HCV HCV HCV HCV Specimen Comments plasma If serum/plasma: requires precision pipette plus tips. plasma If serum/plasma: requires precision pipette plus tips. Wavelength 450/620 nm 450/620nm 450/630 nm Format Line immunoassay/ synthetic peptides Requires incubator, aspirator/vacuum, precision pipette plus tips and other consumables.

8 (Country of manufacture) Product code No. of tests Sensitivity Specificity Shelf life/ storage Detection Specimen Comments HBsAg Rapid Diagnostic Tests (RDTs) Alere Medical Japan Alere Determine TM HBsAg (Matsudo, Japan) HBsAg Enzyme Immunoassays (EIA) J Mitra & Co., India Hepalisa (New Delhi, India) 7D % 99.4% 12 months/ 2 to 30 C IR % 100% 12 months/ HBV surface antigen HBV surface antigen Wavelength 450/630nm If whole : must order chase buffer 7D2211 (2.5ml), optional: EDTA capillary tubes 7D2222, lancets, alcohol swabs. If serum/plasma: requires precision pipette plus tips. Page 8 of 16 Not Applicable

9 (Country of manufacture) CD4 Enumeration Technologies Alere Technologies GmbH Pima CD4 Test (Jena, Germany) Becton, Dickinson and Company, BD Biosciences BD FACSCount Instrument System with FACSCount Control Kit and BD FACSCount Reagent Kit (Absolute CD4+, CD8+, and CD3+ Counts) (San Jose, USA) Becton, Dickinson and Company, BD Biosciences BD FACSCountTM Instrument System with FACSCountTM Control Kit and BD FACSCountTM CD4 Reagent Kit (Absolute and Percentage CD4+ Counts) (San Jose, USA) Product code No. of tests Shelf life/ storage 12 months/ 2 to 30 C 23 (reagent) 24 (control) months/ 15 (reagent) 24 (control) months/ Specimen Comments Venous, capillary whole Venous whole Venous whole Range of accessories also available _0099_032_00_public_ report_v2.pdf 21115_0124_045_00_public_ report_v2_final.pdf 21115_0133_045_00_public_ report_v1_final.pdf Page 9 of 16 Not Applicable

10 Assay Name, Specific Consumables and Product codes Number of Tests Storage Shelf-life Comments HIV Viral Load Technologies Abbott RealTime HIV-1 Abbott Molecular Abbott RealTime HIV-1 (Assay) Extraction reagents: msample Preparation System RNA (4 X 24 Preps) 04J70-24 Amplification Reagents: Abbott RealTime HIV-1 2G31: 2G31-90 (Abbott RealTime HIV-1 Amplication Reagent kit), 2G31-80 (Abbott RealTime HIV-1 Control kit), 2G31-70 (Abbott RealTime HIV-1 Calibrator kit) 4 X 24 Preps 96T/kit 8 runs 4 calibration runs 15 to 30 C -10 C -10 C -10 C 18 months Abbott m2000sp Instrument 9K14-02 Required for m2000sp only Abbott m2000rt Instrument 9K15-01 Abbott m24sp Instrument 3N06-01 Required for m24sp only Abbott m2000rt Optical Calibration kit 4J71-93 Software: Abbott RealTime HIV-1 m2000 ROW System Combined Application CD-ROM 1L68-09 or higher Optional: Abbott RealTime HIV-1 UNG Protocol 2G31-66 Optional for all configurations 5 ml Reaction Vessels 4J Well Optical Reaction Plates 4J7170 Optical Adhesive Covers 4J7175 Adhesive Cover Applicator 9K3201 Splash-Free Support Base 9K ml Screw Top Microfuge Tubes and Caps 4J7150 Required for manual and m24sp Disposable Tips (DiTis), 1000 µl 4J7110 Required for m2000sp and m24sp Disposable Tips (DiTis), 200 µl 4J7117 Required for m2000sp and m24sp Biohazard Bags 4J7145 Required for m2000sp and m24sp 200 ml Reagent Vessels 4J7160 Required for m2000sp and m24sp 96 Deep Well Plates 4J7130 Required for m2000sp and m24sp 13 mm Sample Racks 4J7282 Required for m2000sp and m24sp For a full list of consumables required, see Public reports For the Manual configuration see: ics_la boratory/evaluations/120113_014 6_027_00_final_public_report_v2. pdf For the m2000sp configuration see: ics_la boratory/evaluations/120113_014 5_027_00_final_public_report_v2. pdf For the m24sp configuration see: ics_la boratory/evaluations/120113_008 3_027_00_final_public_report_v2. pdf Page 10 of 16 Not Applicable

11 m2000 msample Preparation System Start Up Kit: Eppendorf Cooler & 2 magnetic stands: (Magnetic Stands for 1 x 5 ml Reaction Vessels and 1 x 1.5 ml tubes) 2N2803 Magnetic Stands for 1 x 5 ml Reaction Vessels and 1 x 1.5 ml tubes 2N2802 Required for m2000sp and m24sp Required for manual only Page 11 of 16 Not Applicable

12 NucliSENS EasyQ HIV-1 v2.0 biomérieux Assay Name, Specific Consumables and Product codes Number of Tests Storage Shelf-life (months) Comments NucliSENS Easy Q HIV-1 V T/kit 18 Required for automated only For a full list of consumables NucliSENS easymag configuration Instrument required for automated only required, see WHO Public Reports NucliSENS easymag extraction Buffer x1L 2 to 30 C 24 Required for automated only NucliSENS easymag extraction Buffer x1L 2 to 30 C 18 Required for automated only For the automated configuration NucliSENS easymag extraction Buffer x1L 15 Required for automated only see: ics_la NucliSENS Magnetic Extraction Reagent T/kit 18 Required for semi-automated only boratory/evaluations/120109_012 NucliSENS Lysis Buffer (2ml) T/kit 2 to 30 C 24 Required for semi-automated only 7_016_00_public_report_v1.pdf NucliSENS easymag extraction Lysis Buffer x1L 2 to 30 C 24 Required for automated only NucliSENS easymag magnetic silica x1L 18 Required for automated only NucliSENS minimag configuration NucliSENS Easy Q configuration Mini Strip Centrifuge Promega Magnetic Rack 12 holes Micro Tubes 1.5 ml with caps Biohit Tips EasyMAG disposables Strip Plates Greiner EasyQ 8-Tube Caps EasyQ 8-Tube Strips Instrument required for semi-automated only Instrument required for both configurations (automated and semi-automated) Required for both configurations (automated and semi-automated) Required for semi-automated only Required for semi-automated only Required for automated only Required for both configurations (automated and semi-automated) Required for automated only Required for both configurations (automated and semi-automated) Required for both configurations (automated and semi-automated) For the semi-automated configuration see: ics_la boratory/evaluations/120109_014 8_016_00_public_report_v1.pdf Page 12 of 16 Not Applicable

13 COBAS AmpliPrep/ COBAS TaqMan HIV-1 Test version 2.0 Roche Molecular Systems Assay Name, Specific Consumables and Product codes COBAS AmpliPrep/ COBAS TaqMan HIV-1 Test version 2.0: COBAS AmpliPrep/ COBAS TaqMan HIV-1 Test version 2.0, COBAS AmpliPrep/COBAS TaqMan Wash Reagent COBAS TaqMan 48 Analyzer COBAS Ampliprep Instrument COBAS TaqMan Analyzer AMPLILINK Software, Version 3.2 Series or AMPLILINK Software, Version 3.3 Series cobas p 630 instrument Docking Station Sample processing units: SPUs Sample input tubes (S-tubes) with barcode clips Racks of K-tips K-tube Box of 12 x Sample Rack (SK 24 rack) Reagent Rack SPU rack K-tube capper, motorized K-tube capper K-carrier K-carrier Transporter K-carrier rack Number of Tests 48T/kit 5.1L Storage Shelf-life (months) 2 to 30 C Comments Instrument required for TaqMan 48 only Required for TaqMan 96 only Optional Instrument Optional Instrument For a full list of consumables required, see WHO Public Reports For the TaqMan 96 configuration see: ics_la boratory/evaluations/120502_014 7_046_00_public_report_v1_final. pdf For the TaqMan 48 configuration see: ics_la boratory/evaluations/120502_012 6_046_00_public_report_v1_final. pdf Page 13 of 16 Not Applicable

14 VERSANT HIV-1 RNA 1.0 Assay (kpcr) Siemens Healthcare Diagnostics Assay Name, Specific Consumables and Product codes Number of Tests Storage Shelf-life (months) Comments VERSANT kpcr Molecular System (Instrument For a full list of consumables VERSANT Sample Preparation 1.0 Reagents, IVDD (Box 1), required, see WHO Public Reports T/kit 15 to 30 C 24 VERSANT Sample Preparation 1.0 Reagents, IVDD (Box 2), ics_la T/kit 24 boratory/evaluations/120213_011 VERSANT HIV-1 RNA Assay 1.0 (kpcr), IVDD (Box 1), T/kit -30 to -10 C 12 5_041_00_public_report_final_v1. VERSANT HIV-1 RNA Assay 1.0 (kpcr) IVDD (Box 2), T/kit -90 to -60 C 12 pdf Large reagent troughs and small reagent troughs, μL pipette tips, μL pipette tips, well, 2-mL nuclease free, sterile deep well plates, Barcoded 96-well semi-skirted polypropylene plates for PCR Optical caps, 8x strip, Page 14 of 16 Not Applicable

15 Assay Name, Specific Consumables and Product codes HIV Virological Technologies for HIV diagnosis, including early infant diagnosis Abbott RealTime HIV-1 Qualitative Abbott Molecular Abbott RealTime HIV-1 Qualitative: Abbott msample Preparation SystemDNA 6K12-24 Abbott RealTime HIV-1 Qualitative Amplification Reagent Kit 4N66-90 Abbott RealTime HIV-1 Qualitative Control Kit 4N66-80 Abbott m2000sp Instrument 9K14-02 Abbott m2000rt Instrument 9K15-01 Abbott RealTime HIV 1 Qualitative m2000 System Combined Application CD ROM 4N66-01 or higher Number of Tests 4 X 24 Preps 96T/kit 8 runs Storage 15 to 30 C -10 C -10 C Page 15 of 16 Not Applicable Shelf-life (months) 18 Comments Required for m2000sp only Software required for all configurations Abbott RealTime HIV-1 UNG Protocol 4N to -25 C. Optional with all configurations Abbott m2000rt Optical Calibration kit 4J ml Reaction Vessels (List No. 4J71-20) Calibrated Pipettes capable of delivering μl Aerosol Barrier Pipette Tips for μl Pipettes 1000 μl Disposable Tips (List No. 4J71-10) 200 μl Disposable Tips (List No. 4J71-17) Vortex Mixer USP Grade Proof Ethanol (95%-100% Ethanol). Abbott Optical Adhesive Covers (List No. 4J71-75) Abbott Adhesive Cover Applicator (List No. 9K32-01) Abbott Splash-Free Support Base (List No. 9K31-01) Master Mix Tube (List No. 4J71-80) 13 mm Sample Racks (List No. 4J72-82) 200 ml Reagent Vessels (List No. 4J71-60) Abbott 96-Deep-Well Plate (List No. 4J71-30) Abbott 96-Well Optical Reaction Plate (List No. 4J71-70) Centrifuge capable of 2000g Bulk mlysisdna Buffer (List No. 2N77-01) For DBS processing only 50 ml Tubes (NUNC or equivalent) (optional) Optional, for DBS processing only For a full list of consumables required, see WHO Public Reports: For the automated configuration see: ics_la boratory/evaluations/130530_0084 _027_00_public_report_final.pdf For the Manual configuration see: ics_la boratory/evaluations/130530_0151 _027_00_public_report_final.pdf

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

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