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 B, and hepatitis C. Previously, this process was called the WHO Test Kit Evaluation programme, it was the predecessor of the WHO Prequalification of Diagnostics Programme. During this transition period, products that were previously evaluated by the WHO Test Kit Evaluation programme and found to meet the acceptance 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. Currently, products that meet either of the following 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). 1) Criteria for all types of assays (HIV, HCV, HBsAg serology, HIV virological, CD4 numeration technologies: a) Meet all requirements for WHO prequalification by WHO Prequalification of Diagnostics programme, including dossier assessment, site inspection and laboratory evaluation according to the acceptance criteria below; 2) Interim criteria for HIV, HCV, HBsAg serology assays only that are not yet WHO prequalified: a) acceptable results for laboratory evaluation in the WHO Test Kit Evaluation programme according to acceptance criteria below, and b) have submitted an application to the WHO Prequalification of Diagnostics programme. Laboratory evaluation acceptance criteria for serology assays: Analyte EIAs Simple assays/rapid diagnostic tests anti- and/or HIV-1 p24 Ag Initial sensitivity: 100% Final specificity: 98% anti-hcv Initial sensitivity: 100% Final specificity: 98% HBsAg Initial sensitivity: 100% Final specificity: 98% Initial sensitivity: 99% Final specificity: 98% Inter-reader variability: 5% Invalid rate: 5% Initial sensitivity: 98% Final specificity: 97% Inter-reader variability: 5% Invalid rate: 5% Initial sensitivity: 100% Final specificity: 98% Inter-reader variability: 5% Invalid rate: 5% Ineligibility for procurement Products may be ineligible for procurement by WHO if made obsolete by their manufacturer, if de-listed from the list of WHO prequalified products, if Field Safety Notice or Notice of Concern is active. See web address for reports containing WHO Test Kit Evaluation programme data at ics_laboratory/publications/evaluations/en/index.html See web address for WHO Prequalification of Diagnostics Public Reports at ics_laboratory/evaluations/pq_list/en/index.html See web address for outstanding Notice of Concerns and Field Safety Notices at ics_laboratory/procurement/complaints/en/ Shelf life Shelf life upon manufacture is stated by the manufacturer at the time of WHO prequalification, and supported by evidence in the product dossier. Guaranteed minimum shelf life upon delivery is likely to be less and should be negotiated as part of the bidding process. For this list, shelf life upon manufacture is listed. Further information contact by e-mail: diagnostics@who.int Version 15, 7 October 2014 - This version of the list supersedes all previous version. Initial sensitivity and final specificity results generated using the WHO serum/plasma specimen panel as obtained during either the laboratory evaluation of WHO prequalification or the WHO Test Kit Evaluation programme. : Not Applicable

Product code No. of tests Initial sensitivity Final specificity Analyte type HIV Simple Assays/Rapid Diagnostic Tests (RDTs) ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device (Whole Blood/ Serum/Plasma ABON Biopharm (Hangzhou) CO., LTD (Hangzhou, PR China) Alere Medical Co. Ltd. Alere Determine (Matsudo, Japan) IHI-T402W 40 100% 99.7% 24 months/ 2 to 30 C 7D2342 7D2343 20 100 100% 99.4% 14 months/ 2 to 30 C HIV-1 and HIV-2 If whole : lancets, alcohol swabs, and heparinized capillary tubes with 50 µl mark line and dispensing bulb. If whole : lancets, alcohol swabs, chase buffer (7D2211), EDTA capillary tubes (7D2222). If serum/plasma: requires precision pipette plus tips. 40924_public_report_abon_h iv_triline_rdt_v2.0.pdf?ua=1 11125_0033_013_00_public_ report_final.pdf Alere Medical Co. Ltd. Alere Determine Ag/Ab Combo (Matsudo, Japan) biolytical Laboratories Insti HIV-1/HIV-2 Antibody Rapid Test (Richmond, Canada) biomérieux VIKIA HIV 1/2 (Marcy l'etoile, France) 7D2643 100 100% 98.8% 10 months/ 2 to 30 C 90-1012 90-1013 90-1010 90-1022 90-1021 1 24 24 48 48 100% 99.7% 15 months/ 15 to 30 C 311112 25 99.4% 99.9% 21 months/ 4 to 30 C and HIV-1 p24 antigen If whole : lancets, alcohol swabs, chase buffer (7D2211),EDTA capillary tubes (7D2222). If serum/plasma: requires precision pipette plus tips. If 90-1010, 90-1021: lancets, alcohol swabs, precision pipette plus tips. If whole : lancets, 20320_0034_013_00_final_p ublic_report_version2.pdf 30829_0002-002- 00_public_report_final_v1.pd f 31212_0150_016_00_public_ report_final_v1.pdf Version 15, 7 October 2014 - This version of the list supersedes all previous version. Initial sensitivity and final specificity results generated using the WHO serum/plasma specimen panel as obtained during either the laboratory evaluation of WHO prequalification or the WHO Test Kit Evaluation programme. : Not Applicable

Product code No. of tests Initial sensitivity Final specificity Analyte type HIV Simple Assays/Rapid Diagnostic Tests (RDTs) Chembio Diagnostic Systems, Inc. HIV 1/2 STAT-PAK (Medford, USA) Chembio Diagnostic Systems, Inc. HIV 1/2 STAT-PAK Dipstick (Medford, USA) OraSure Technologies Inc. OraQuick Rapid Antibody Test (Bangkok, Thailand) HIV101 20 99.3% 100% 24 months/ 8 to 30 C HIV303 30 100% 99.7% 24 months/ 8 to 30 C 5X4-0010 5X4-0012 100 500 100% 99.2% 8 months/ 2 to 30 C, oral fluid If whole : lancets, HIV Test Kit Controls (HIV104) available. If whole : lancets, If alternate procedure: must order sample tubes and tube rack. If whole : lancets, alcohol swabs, additional specimen loops (004-001). 20116_0007_006_00_public_ report_final_v1.pdf 11125_0008_006_00_public_ report_final.pdf Orgenics Ltd. Immunocomb II HIV 1&2 BiSpot (Yavne, Israel) 6042002 36 100% 99.4% 15 months/ HIV-1 and HIV-2 plasma Not suitable for whole Requires precision pipette plus tips. 40929_public_report_immun ocomb_hiv_bispot_v2.pdf?ua =1 Premier Medical Corporation Ltd. First Response HIV 1-2-0 Card Test (Daman, India) I05FRC30 30 100% 98.8% 23 months/ 4 to 30 C HIV-1 and HIV-2 If whole : lancets, Page 3 of 13

Product code No. of tests Initial sensitivity Final specificity Analyte type HIV Simple Assays/Rapid Diagnostic Tests (RDTs) Shanghai Kehua Bioengineering Co. Ltd. Diagnostic Kit for HIV (1+2) Antibody (Colloidal Gold) (Shanghai, PR China) Standard Diagnostics, Inc. SD BIOLINE 3.0 (Yongin-si, Korea) Standard Diagnostics, Inc. SD BIOLINE HIV Ag/Ab Combo (Yongin-si, Korea) Trinity Biotech Manufacturing Ltd. Uni-Gold HIV (Bray, Ireland) KH-R-02 50 100% 100% 15 months/ 4 to 30 C 03FK16 03FK10 03FK35 03FK30 1206502 1206502N 1206502E 25 30 25 30 99.8% 99.9% 24 months/ 1 to 30 C 100% 99.1% months/ 1 to 30 C 20 99.8% 99.9% 12 months/ 2 to 27 C detection HIV-1 and HIV-2 and HIV-1 p24 antigen detection Requires precision pipette plus tips. If whole : lancets, If whole : lancets, If 03FK10: lancets, capillary pipettes, If whole : lancets, If 03FK30: lancets, capillary pipettes, If whole : lancets, http://www.who.int/diagn ostics_laboratory/evaluati ons/130528_0027_012_00 _public_report_final_v2.p df 30322_0069_012_00_public_ report_final_v1.pdf 21213_0149-052- 00_public_report_v1.pdf Page 4 of 13

Product code No. of tests Initial sensitivity Final specificity Analyte Wavelength HIV Enzyme Immunoassays (EIAs) Bio-Rad Genscreen ULTRA HIV Ag-Ab (Steenvoorde, France) HIV Supplemental Assays Fujirebio Europe N.V. INNO-LIA TM HIV I/II SCORE (Ghent, Belgium) MP Biomedicals Asia Pacific Pte. Ltd. HIV BLOT 2.2 (Singapore, Singapore) 72386 72388 96 480 100% 99.2% months/ 80540 20 12 months/ 11030-036 36 11 months/ and HIV-1 p24 antigen HIV-1 and HIV-2 HIV-1 and HIV-2 450/ 620-700 nm Format line immunoassay / recombinant proteins, synthetic peptides Western blot/ viral lysate, synthetic peptide Not suitable for whole Requires EIA incubator, washer, reader, precision pipette plus tips, deionised water. Not suitable for whole Requires precision pipette plus tips and other consumables. Not suitable for whole Requires precision pipette plus tips and other consumables. 30408_0096-031- 00_public_report_final_v1.pd f Page 5 of 13

Product code No. of tests Initial sensitivity Final specificity Analyte type HCV Rapid Diagnostic Tests (RDTs) HCV Enzyme Immunoassays (EIAs) Fujirebio Europe N.V. INNOTEST HCV Ab IV (Ghent, Belgium) HCV Supplemental Assays Fujirebio Europe N.V. INNO-LIA HCV Score (Ghent, Belgium) 80068 80330 192 480 100% 100% 10 months/ 80538 20 10 months/ HCV HCV Wavelength 450/620nm Format Line immunoassay/ synthetic peptides Not suitable for whole Requires EIA incubator, washer, reader, precision pipette plus tips, deionised water. Not suitable for whole Requires incubator, aspirator/vacuum, precision pipette plus tips and other consumables. Page 6 of 13

Product code No. of tests Initial sensitivity Final specificity Analyte type HBsAg Rapid Diagnostic Tests (RDTs) Alere Medical Co. Ltd. Alere Determine TM HBsAg (Matsudo, Japan) HBsAg Enzyme Immunoassays (EIAs) DiaSorin S.p.A UK Branch Murex HBsAg Version 3 Confirmatory Reagents (Dartford, UK) 7D2513 100 99.0% 99.4% 12 months/ 2 to 30 C 9F80-01 9F80-05 2G27-01 96 480 50 100% 98.3% 12 months/ HBV surface antigen HBV surface antigen Wavelength 450/ 620-690 If whole : lancets, alcohol swabs, chase buffer (7D2211), EDTA capillary tubes (7D2222). If serum/plasma: requires precision pipette plus tips. Not suitable for whole Requires EIA incubator, washer, reader, precision pipette plus tips, deionised water, 2M sulphric acid. Page 7 of 13

CD4 Enumeration Technologies Alere Technologies GmbH Pima CD4 Test (Jena, Germany) Product code 260300001 (instrument) 260100100 (test kit) No. of tests 100 12 months (reagent) / 2 to 30 C type Venous and capillary whole Accessories available. http://www.who.int/diagn ostics_laboratory/evaluati ons/111208_0099_032_00 _public_report_v2.pdf 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) Becton, Dickinson and Company, BD Biosciences BD FACSPresto Near Patient CD4 system 337858 (instrument) 340167 (test kit) 340166 (control kit) 337858 (instrument) 339010 (test kit) 340166 (control kit) 651000 (instrument) 657681 (cartridge) 655495 (cartridge kit) 50 25 50 25 100 100 23 months (reagent), 24 months (control) / 15 months (reagent), 24 months (control) / 12 months /4-31 C Venous whole Venous whole Venous and capillary whole BD FACSPresto work Station and accessories also available http://www.who.int/diagn ostics_laboratory/evaluati ons/121115_0124_045_00 _public_report_v2_final.p df http://www.who.int/diagn ostics_laboratory/evaluati ons/121115_0133_045_00 _public_report_v1_final.p df http://www.who.int/diagn ostics_laboratory/evaluati ons/1409_public_report _bdfacspresto_cd4.pdf?ua =1 Page 8 of 13

HIV Viral Load Technologies Abbott Molecular Abbott RealTime HIV-1 (Des Plaines, USA) Assay Name, Specific Consumables and Product codes 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) Number of Tests 4 X 24 Preps 96T/kit 8 runs 4 runs Page 9 of 13 Storage 15 to 30 C -10 C -10 C -10 C Shelflife months Type Plasma 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 4J7120 96-Well Optical Reaction Plates 4J7170 Optical Adhesive Covers 4J7175 Adhesive Cover Applicator 9K3201 Splash-Free Support Base 9K3101 1.5 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 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 Required for m2000sp and m24sp Magnetic Stands for 1 x 5 ml Reaction Vessels and 1 x 1.5 ml tubes 2N2802 Required for manual only For a full list of consumables required, see Public reports For the Manual http://www.who.int/diag nostics_laboratory/evalu ations/120113_0146_027 _00_final_public_report_ v2.pdf For the m2000sp http://www.who.int/diag nostics_laboratory/evalu ations/120113_0145_027 _00_final_public_report_ v2.pdf For the m24sp http://www.who.int/diag nostics_laboratory/evalu ations/120113_0083_027 _00_final_public_report_ v2.pdf

biomérieux NucliSENS EasyQ HIV- 1 v2.0 (Marcy L Etoile, France) Assay Name, Specific Consumables and Product codes NucliSENS Easy Q HIV-1 V2.0 285033 Number of Tests Storage Shelf-life (months) Type Plasma, dried spot (venous whole ) 48T/kit NucliSENS easymag configuration Instrument required for automated only 4700014 NucliSENS easymag extraction Buffer 1 24 280130 4x1L 2 to 30 C NucliSENS easymag extraction Buffer 2 280131 4x1L 2 to 30 C NucliSENS easymag extraction Buffer 3 15 280132 4x1L NucliSENS Magnetic Extraction Reagent Required for semi-automated only 200293 48T/kit NucliSENS Lysis Buffer (2ml) 200292 48T/kit 2 to 30 C 24 Required for semi-automated only NucliSENS easymag extraction Lysis 24 Buffer 280134 4x1L 2 to 30 C NucliSENS easymag magnetic silica 280133 4x1L NucliSENS minimag configuration Instrument required for semi-automated only 4700015 NucliSENS Easy Q configuration 4700016 Instrument required for both configurations (automated and semiautomated) Mini Strip Centrifuge 285056 Required for both configurations (automated and semi-automated) Promega Magnetic Rack 12 holes 200299 Required for semi-automated only Micro Tubes 1.5 ml with caps 200294 Required for semi-automated only Biohit Tips 280146 EasyMAG disposables 280135 Required for both configurations (automated and semi-automated) Strip Plates Greiner 278303 EasyQ 8-Tube Caps 285051 Required for both configurations (automated and semi-automated) EasyQ 8-Tube Strips 285048 Required for both configurations (automated and semi-automated) For a full list of consumables required, see WHO Public Reports For the automated http://www.who.int/ diagnostics_laborato ry/evaluations/1201 09_0127_016_00_pu blic_report_v1.pdf For the semiautomated http://www.who.int/ diagnostics_laborato ry/evaluations/1201 09_0148_016_00_pu blic_report_v1.pdf Page 10 of 13

Roche Molecular Systems COBAS AmpliPrep/ COBAS TaqMan HIV-1 Test version 2.0 (Branchburg, USA) 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, 05212294190 COBAS AmpliPrep/COBAS TaqMan Wash Reagent 03587797190 Number of Tests 48T/kit 5.1L Storage 2 to 30 C Shelf-life (months) 24 type Plasma COBAS TaqMan 48 Analyzer 03279332001 Instrument required for TaqMan 48 only COBAS Ampliprep Instrument 03051315001 COBAS TaqMan Analyzer 03121453001 Required for TaqMan 96 only AMPLILINK Software, Version 3.2 Series 04862392001 or AMPLILINK Software, Version 3.3 Series 05807875001 cobas p 630 instrument 05527503001 Optional Instrument Docking Station 28127387001 Optional Instrument Sample processing units: SPUs 03755525001 Sample input tubes (S-tubes) with barcode clips 03137040001 Racks of K-tips 03287343001 K-tube Box of 12 x 9603137082001 Sample Rack (SK 24 rack) 028122172001 Reagent Rack 028122199001 SPU rack 05471664001 K-tube capper, motorized 03516539001 K-tube capper 03339874001 K-carrier 03341488001 K-carrier Transporter 03517519001 K-carrier rack 03286436001 For a full list of consumables required, see WHO Public Reports For the TaqMan 96 http://www.who.int/diagnos tics_laboratory/evaluations/ 120502_0147_046_00_publi c_report_v1_final.pdf For the TaqMan 48 http://www.who.int/diagnos tics_laboratory/evaluations/ 120502_0126_046_00_publi c_report_v1_final.pdf Page 11 of 13

Siemens Healthcare Diagnostics VERSANT HIV-1 RNA 1.0 Assay (kpcr) (Tarrytown, USA) Assay Name, Specific Consumables and Product codes Numb er of Tests Storage Shelf-life (months) VERSANT kpcr Molecular System 10467524 (Instrument VERSANT Sample Preparation 1.0 Reagents, IVDD (Box 1), 04801677 96T/kit 15 to 30 C 24 VERSANT Sample Preparation 1.0 Reagents, IVDD (Box 2), 04801685 96T/kit 24 VERSANT HIV-1 RNA Assay 1.0 (kpcr), IVDD (Box -30 to - 1), 10375763 96T/kit 10 C 12 VERSANT HIV-1 RNA Assay 1.0 (kpcr) IVDD (Box 2), -90 to - 10375764 96T/kit 60 C 12 Large reagent troughs and small reagent troughs, 10489008 1000-μL pipette tips, 06635759 300-μL pipette tips, 06635767 96-well, 2-mL nuclease free, sterile deep well plates, 06691055 Barcoded 96-well semi-skirted polypropylene plates for PCR 06653412 Optical caps, 8x strip, 06653439 type Plasma For a full list of consumables required, see WHO Public Reports ics_labora tory/evaluations/120213_0115_041_00 _public_report_final_v1.pdf Page 12 of 13

Assay Name, Specific Consumables and Product codes Number of Tests Storage Shelf-life (months) Type Abbott Molecular Abbott RealTime HIV-1 Qualitative (Des Plaines, USA) HIV Virological Technologies for HIV diagnosis, including early infant diagnosis 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 4 X 24 Preps 96T/kit 8 runs 15 to 30 C -10 C -10 C Plasma, dried spot Abbott m2000sp Instrument 9K14-02 Required for m2000sp only Abbott m2000rt Instrument 9K15-01 Abbott RealTime HIV 1 Qualitative m2000 System Software required for all Combined Application CD ROM 4N66-01 or higher configurations Abbott RealTime HIV-1 UNG Protocol 4N66-66 -15 to -25 C. Optional with all configurations Abbott m2000rt Optical Calibration kit 4J71-93 5 ml Reaction Vessels (List No. 4J71-20) Calibrated Pipettes capable of delivering 20 1000 μl Aerosol Barrier Pipette Tips for 20-1000 μl Pipettes 1000 μl Disposable Tips (List No. 4J71-10) 200 μl Disposable Tips (List No. 4J71-17) Vortex Mixer USP Grade 190-200 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 http://www.who.int/diagno stics_laboratory/evaluations /130530_0084_027_00_pub lic_report_final.pdf For the Manual http://www.who.int/diagno stics_laboratory/evaluations /130530_0151_027_00_pub lic_report_final.pdf Page 13 of 13