Initial sensitivity: 99% Initial sensitivity: 100% Final specificity: 98% Final specificity: 98%

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1 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 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 s 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 s_laboratory/publications/evaluations/en/index.html See web address for WHO Prequalification of Diagnostics Public Reports at s_laboratory/evaluations/pq_list/en/index.html See web address for outstanding Notice of Concerns and Field Safety Notices at s_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 diagnostics@who.int Version 22, 5 October 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

2 List of in vitro diagnostics eligible to tender for procurement by WHO in 2016 (including WHO prequalified in vitro diagnostics) (Country of manufacture) 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) Alere Medical Co. Ltd. Alere HIV Combo (Matsudo, Japan) biolytical Laboratories Insti HIV-1/HIV-2 Antibody Rapid Test (Richmond, Canada) biomérieux VIKIA HIV 1/2 (Marcy l'etoile, France) Product code No. of tests Initial sensitivity Final specificity Shelf life/ storage IHI-T402W % 99.7% 24 2 to 30 C 7D2342 7D2343 7D2842 7D2843 7D2843SET % 99.4% 14 2 to 30 C 100% 99.4% 18 2 to 30 C 100% 99.7% to 30 C % 99.9% 21 months / 4 to 30 C Version 22, 5 October 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 Analyte Discrimination between HIV-1 and HIV-2 and HIV antigen If whole : lancets, alcohol swabs, and heparinized capillary tubes with 50 L 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. If whole (excluding 7D2843SET) : lancets, alcohol swabs, chase buffer (7D2211), EDTA capillary tubes (7D2222). If serum/plasma: requires precision pipette plus tips. If , : lancets, alcohol swabs, precision pipette plus tips. If whole : lancets, alcohol swabs. s_laboratory/evaluations/ _public_report_abon_hiv_tril ine_rdt_v2.0.pdf?ua=1 s_laboratory/evaluations/ _0033_013_00_public_repor t_final.pdf s_laboratory/evaluations/pqlist/hivrdts/160712_final_public_repo rt_0243_013_00_v3.pdf?ua=1 s_laboratory/evaluations/ _ _public_report_final_v1.pdf s_laboratory/evaluations/ _0150_016_00_public_repor t_final_v1.pdf

3 (Country of manufacture) Chembio Diagnostic Systems, Inc. DPP HIV 1/2 Assay (Medford, USA) Chembio Diagnostic Systems, Inc. HIV 1/2 STAT-PAK (Medford, USA) Chembio Diagnostic Systems, Inc. HIV 1/2 STAT-PAK Dipstick (Medford, USA) Chembio Diagnostic Systems, Inc. SURE CHECK HIV 1/2 Assay (Medford, USA) OraSure Technologies Inc. OraQuick Rapid Antibody Test (Bangkok, Thailand) Premier Medical Corporation Ltd. First Response HIV Card Test (Daman, India) Trinity Biotech Manufacturing Ltd. Uni-Gold HIV (Bray, Ireland) Product code No. of tests Initial sensitivity % 99.1% Final specificity 99.9% 100% Shelf life/ storage 24 months / 2 to 30 C HIV % 100% 24 8 to 30 C HIV % 99.7% 24 8 to 30 C HIV % 99.9% 24 8 to 30 C 5X X % (P) 99.1% (OF) 99.8% (P) 100% (OF) 30 2 to 30 C I05FRC % 98.8% 23 4 to 30 C N E % 99.9% 12 2 to 27 C Page 3 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable Analyte Discrimination between HIV-1 and HIV-2 detection, oral fluid, oral fluid If whole : lancets, alcohol swabs. If serum/plasma: precision pipette plus tips. 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. If whole : lancets, alcohol swabs, additional specimen loops ( ). OraQuick ADVANCE Rapid Antibody Test Kit Controls ( ) If whole : lancets, alcohol swabs. If whole : lancets, alcohol swabs. s_laboratory/evaluations/pqlist/hivrdts/160606pqpr_ _DPPHIV_v2.pdf?ua=1 s_laboratory/evaluations/ _0007_006_00_public_repor t_final_v1.pdf s_laboratory/evaluations/ _0008_006_00_public_repor t_final.pdf s_laboratory/evaluations/ _final_report_sure_check_hi v_1_2_assay.pdf?ua=1 s_laboratory/evaluations/pqlist/hivrdts/160616_amended_final_p ublic_report_0159_055_00_v3. pdf?ua=1 s_laboratory/evaluations/pqlist/hivrdts/160715_final_public_repo rt_0018_010_00.pdf?ua=1 s_laboratory/evaluations/ _ _public_report_v1.pdf

4 (Country of manufacture) HIV/ Treponema pallidum Rapid Diagnostic Tests (RDTs) Standard Diagnostics, Inc. SD Bioline HIV/Syphilis DUO (Yongin-si, Korea) HIV Enzyme Immunoassays (EIAs) Biokit S.A. bioelisa HIV 1+2 Ag/Ab (Barcelona, Spain) Bio-Rad Genscreen ULTRA HIV Ag-Ab (Steenvoorde, France) DiaSorin S.p.A UK Branch Murex HIV Ag/Ab Combination (Dartford, UK) RPC Diagnostic Systems DS-EIA-HIV-AGAB-SCREEN (Nizhny Novgorod, Russian Federation) Product code 06FK30 06FK G G79-11 I-1652 I-1654 I-1656 No. of tests Initial sensitivity 100 (HIV) 86.5 (TP) Final specificity 99.5 (HIV) 99.5 (TP) Shelf life/ storage 24 1 to 30 C 100% 99.4% 9 100% 99.2% % 99.7% % 98.8% 24 Analyte and Treponemal and HIV-1 p24 antigen and HIV-1 p24 antigen and HIV-1 p24 antigen and HIV-1 p24 antigen 450/ nm 450/ nm 450/ nm 450/ nm If 06FK30: lancets, capillary pipettes, alcohol swabs. Not suitable for whole Not suitable for whole Not suitable for whole Not suitable for whole s_laboratory/evaluations/ _final_report_ _sd_bioline_hiv_syphilis2.pd f s_laboratory/evaluations/ _final_report_biolisa_hiv_ag _ab_v3.pdf?ua=1 s_laboratory/evaluations/ _ _public_report_final_v1.pdf s_laboratory/evaluations/ _final_report_murex_hiv_ag _ab.pdf?ua=1 s_laboratory/evaluations/ _final_report_0106_038_00_ eia.pdf?ua=1 Page 4 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable

5 (Country of manufacture) Siemens Healthcare Diagnostics Products GmbH Enzygnost HIV Integral 4 and Supplementary reagents kit for Enzygnost /TMB (Marburg, Germany) HIV Supplemental Assays Fujirebio Europe N.V. INNO-LIA TM HIV I/II SCORE (Ghent, Belgium) Product code OPKR03 OPKR05 OPKR05(Q) OUVP17 No. of tests Initial sensitivity Final specificity Shelf life/ storage 100% 99.8% Analyte and HIV-1 p24 antigen Discrimination between HIV-1 and HIV-2 450/650 Not suitable for whole ELISA processors (one of BEP III System, BEP 2000 System,BEP 2000 Advance System, Quadriga or Quadriga BeFree Systems line immunoassay / recombinant proteins, synthetic peptides Not suitable for whole Requires precision pipette plus tips and other consumables. s_laboratory/evaluations/ _final_public_report_0214_0 64_00.pdf?ua=1 s_laboratory/evaluations/ _final_report_innolia_hiv_sc ore.pdf?ua=1 MP Biomedicals Asia Pacific Pte. Ltd. HIV BLOT 2.2 (Singapore, Singapore) Discrimination between HIV-1 and HIV-2 Western blot/ viral lysate, synthetic peptide Not suitable for whole Requires precision pipette plus tips and other consumables. s_laboratory/evaluations/ _final_public_report_0198_0 71_00_v2.pdf?ua=1 Page 5 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable

6 (Country of manufacture) Product code No. of tests Initial sensitivity Final specificity Shelf life/ storage Analyte HCV Rapid Diagnostic Tests (RDTs) HCV Enzyme Immunoassays (EIAs) Biokit S.A Biolisa HCV 4.0 (Barcelona, Spain) DiaSorin South Africa (Pty) Ltd. Murex anti-hcv (version 4.0) (South Africa) Fujirebio Europe N.V. INNOTEST HCV Ab IV (Ghent, Belgium) HCV Supplemental Assays Fujirebio Europe N.V. INNO-LIA HCV Score (Ghent, Belgium) F F % 100% % 99.4% % 100% HCV HCV HCV HCV Wavelength 450/ nm 450 nm/ nm 450/620nm Format Line immunoassay/ synthetic peptides Not suitable for whole Not suitable for whole Not suitable for whole Not suitable for whole Requires incubator, aspirator/vacuum, precision pipette plus tips and other consumables. ostics_laboratory/evaluatio ns/150331_final_report_bi oelisa_hcv_4.0.pdf?ua=1 ostics_laboratory/evaluatio ns/150608_final_report_01 64_059_00_murex_hcv_ves ion_4_0.pdf?ua=1 In progress ostics_laboratory/evaluatio ns/150729_final_report_02 02_073_00_hcv.pdf?ua=1 Page 6 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable

7 (Country of manufacture) Product code No. of tests Initial sensitivity Final specificity Shelf life/ storage Analyte HBsAg Rapid Diagnostic Tests (RDTs) HBsAg Enzyme Immunoassays (EIAs) DiaSorin S.p.A UK Branch Murex HBsAg Version 3 with Confirmatory Reagents (Dartford, UK) Siemens Healthcare Diagnostics Products GmbH Enzygnost HBsAg 6.0 and Supplementary reagents kit for Enzygnost /TMB (Marburg, Germany) 9F F G27-01 OPFM03 OPFM05 OPFM05(Q) OUVP % 98.3% % 100% 12 HBV surface antigen HBV surface antigen Wavelength 450/ Not suitable for whole water, 2M sulphric acid. 450/630 Not suitable for whole Requires ELISA processors (one of BEP III System, BEP 2000 System,BEP 2000 Advance System, Quadriga or Quadriga BeFree Systems) or EIA incubator, ics_laboratory/evaluations/ _public_report_diasori n_murex_hbsag_v1.pdf?ua=1 ics_laboratory/evaluations/ _final_public_report_0 173_064_00.pdf?ua=1 Page 7 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable

8 (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 FACSCount Instrument System with FACSCount Control Kit and BD FACSCount CD4 Reagent Kit (Absolute and Percentage CD4+ Counts) (San Jose, USA) Becton, Dickinson and Company, BD Biosciences BD FACSPresto Near-Patient CD4 Counter, BD FACSPresto Cartridge and BD FACSPresto cartridge kit (San Jose, USA/Singapore) Beckman Coulter Life Sciences Aquios CL flow cytometer (Miami, USA/Hialeah, USA) B39101 B39102 B23533 B23535 B25700 Product code instrument test kit instrument test kit control kit instrument test kit control kit instrument cartridge cartridge kit instrument +110V UPS instrument +220V UPS reagents controls controls No. of tests Shelf life/ storage 12 months (reagent) / 2 to 30 C 23 months (reagent), 24 months (control) / 15 months (reagent), 24 months (control) / Venous and capillary whole Venous whole Venous whole 12 months /4-31 C Venous and capillary whole days/ 270 days/ Venous whole Accessories available. s_ laboratory/evaluations/111208_0 099_032_00_public_report_v2.p df s_ laboratory/evaluations/pqlist/cd4/160530_0124_045_00_p ublic_report_v2_final.pdf?ua=1 s_ laboratory/evaluations/pqlist/cd4/160530_0133_045_00_p ublic_report_v1_final.pdf?ua=1 Page 8 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable BD FACSPresto work Station and accessories also available s_ laboratory/evaluations/121115_0 133_045_00_public_report_v1_fi nal.pdf s_ laboratory/evaluations/160324_a mended_final_public_report_pqd x_0197_045_00.pdf?ua=1 s_ laboratory/evaluations/151109_f inal_report_ _aquios_cl_flow_cytometer.pd f?ua=1

9 HIV Quantitative Nucleic Acid Testing Technologies, for viral load Abbott Molecular Abbott RealTime HIV-1 (Des Plaines, USA), 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 Amplification Reagent kit), 2G31-80 (Abbott RealTime HIV-1 Control kit), 2G31-70 (Abbott RealTime HIV-1 Calibrator kit) Abbott m2000sp Instrument 9K14-02 Abbott m2000rt Instrument 9K15-01 Abbott m24sp Instrument 3N06-01 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 Number of tests 4 X 24 Preps T/kit 8 runs 4 runs Page 9 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable Storage C -10 C -10 C -10 C Shelflife 18 months Plasma Required for m2000sp only Required for m24sp only Optional for all configurations 5 ml Reaction Vessels 4J7120 -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 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: (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 Required for m2000sp and m24sp Required for manual only For a full list of consumables required, see Public reports For the Manual nostics_laboratory/evalu ations/120113_0146_027 _00_final_public_report_ v2.pdf For the m2000sp nostics_laboratory/evalu ations/120113_0145_027 _00_final_public_report_ v2.pdf For the m24sp nostics_laboratory/evalu ations/120113_0083_027 _00_final_public_report_ v2.pdf

10 1.5 ml tubes 2N2802 biomérieux NucliSENS EasyQ HIV-1 v2.0 (Marcy L Etoile, France), specific consumables and product codes Number of tests Storage Shelflife NucliSENS Easy Q HIV-1 V NucliSENS easymag configuration NucliSENS easymag extraction Buffer T/kit 4x1L 2-8 C 2-30 C Plasma, dried spot Required for automated only Required for automated only Required for automated only NucliSENS easymag extraction Buffer x1L 2-30 C 18 (venous Required for automated only NucliSENS easymag extraction Buffer x1L 2-8 C 15 whole Required for automated only ) NucliSENS Magnetic Extraction Reagent T/kit 2-8 C 18 Required for semi-automated only NucliSENS Lysis Buffer (2ml) T/kit 2-30 C 24 Required for semi-automated only NucliSENS easymag extraction Lysis Buffer x1L 2-30 C 24 Required for automated only NucliSENS easymag magnetic silica x1L 2-8 C 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 Required for semi-automated only 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 a full list of consumables required, see WHO Public Reports For the automated ostics_laboratory/evaluati ons/120109_0127_016_00 _public_report_v1.pdf For the semi-automated ostics_laboratory/evaluati ons/120109_0148_016_00 _public_report_v1.pdf Page 10 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable

11 Roche Molecular Systems COBAS AmpliPrep/COBAS TaqMan HIV 1 Test version 2.0 (Branchburg, USA) Assay Name, Specific Consumables and Product codes Number of Tests Storage Shelflife COBAS AmpliPrep/COBAS TaqMan HIV 1 Test version 2.0: Plasma COBAS AmpliPrep/COBAS TaqMan HIV 1 Test version 48T/kit 2-8 C , COBAS AmpliPrep/COBAS TaqMan Wash Reagent L 2-30 C 24 COBAS TaqMan 48 Analyzer Required for TaqMan 48 only COBAS Ampliprep Instrument COBAS TaqMan Analyzer Required for TaqMan only AMPLILINK Software, Version 3.2 Series or AMPLILINK Software, Version 3.3 Series cobas p 630 instrument Optional Instrument Docking Station Optional Instrument 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 For a full list of consumables required, see WHO Public Reports For the TaqMan tics_laboratory/evaluations/ _0147_046_00_publi c_report_v1_final.pdf For the TaqMan 48 tics_laboratory/evaluations/ _0126_046_00_publi c_report_v1_final.pdf Page 11 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable

12 Siemens Healthcare Diagnostics VERSANT HIV-1 RNA 1.0 Assay (kpcr) (Tarrytown, USA), specific consumables and product codes Number of tests Storage Shelflife VERSANT kpcr Molecular System (Instrument) Plasma For a full list of consumables VERSANT Sample Preparation 1.0 Reagents, IVDD (Box 15 to required, see WHO Public 1), T/kit 30 C 24 Report VERSANT Sample Preparation 1.0 Reagents, IVDD (Box 2), T/kit 24 VERSANT HIV-1 RNA Assay 1.0 (kpcr), IVDD (Box 1), -30 to - tics_laboratory/evaluations/ T/kit 10 C _0115_041_00_publi VERSANT HIV-1 RNA Assay 1.0 (kpcr) IVDD (Box 2), -90 to - c_report_final_v1.pdf T/kit 60 C Large reagent troughs and small reagent troughs, μL pipette tips, μL pipette tips, well, 2-mL nuclease free, sterile deep well plates, Barcoded -well semi-skirted polypropylene plates for PCR Optical caps, 8x strip, Page 12 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable

13 , specific consumables and product codes HIV Qualitative Nucleic Acid Testing Technologies for HIV diagnosis, including early infant diagnosis Abbott Molecular Abbott RealTime HIV-1 Qualitative (Des Plaines, USA) Abbott RealTime HIV-1 Qualitative: Abbott msample Preparation System DNA 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 T/kit 8 runs Storage C -10 C -10 C Shelf-life 18 Specime n Type Plasma, dried spot 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 -Deep-Well Plate (List No. 4J71-30) Abbott -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 stics_laboratory/evaluations /130530_0084_027_00_pub lic_report_final.pdf For the Manual stics_laboratory/evaluations /130530_0151_027_00_pub lic_report_final.pdf Page 13 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable

14 Alere Technologies GmbH Alere q Detect (Jena, Germany) Cepheid AB Xpert HIV-1 Qual Assay with GeneXpert Dx, GeneXpert Infinity-48s, and GeneXpert Infinity-80 Infinity-80 Roche Diagnostics GmbH COBAS AmpliPrep/ COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) and COBAS AmpliPrep/ COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan ) (Branchburg, USA), specific consumables and product codes Alere q Detect Cartridge Kit Alere q Detect Cartridge Kit Xpert HIV-1 Qual Assay contains HIV-1 Qual Assay Cartridges with Integrated Reaction Tubes HIV-1 Qual Assay Sample Reagent Set (Sample Reagent) Disposable 1 ml Transfer Pipettes Disposable 100 μl Transfer Micropipettes Number of tests Page 14 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable Storage Shelflife 4-30 C 9 Venous whole, EDTA plasma C 8 Venous whole, capillary or EDTA venous dried spot COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0, T/kit 2-8 C 22 COBAS AmpliPrep/COBAS TaqMan Wash Reagent L 2-30 C 24 COBAS AmpliPrep/COBAS TaqMan Pre-Extraction Reagent x78mL 2-8 C 12 COBAS TaqMan Analyzer, or COBAS TaqMan 48 Analyzer, COBAS AmpliPrep Instrument, AMPLILINK Software, Version 3.3 Series or higher, XP Data Station for AMPLILINK S/W with Printer, Sample processing units(spus), Sample input tubes (S-tubes) with barcode clips, Racks of K-tips K-tube (Box of 12 x ), Plasma, dried spot See public report for details of instrument configurations and items required but not provided. See public report for details of instrument configurations and items required but not provided. Required for DBS processing only Instrument: one required for all configurations Add Add For a full list of consumables required, see WHO Public Reports: stics_laboratory/evaluations /141216_final_report_taqm an48_0221_v2.pdf?ua=1 stics_laboratory/evaluations /141216_final_report_taqm an_0200_v2.pdf?ua=1

15 Sample rack (SK 24 rack), Reagent rack, SPU rack, K-tube capper, motorized, K-tube capper, K-carrier, K-carrier transporter, K-carrier rack, XP Data Station for the AMPLILINK S/W with printer, Docking Station Short, Pipettors with aerosol barrier or positive displacement RNase-free tips (capacity 1000 μl) cobas p 630 instrument, (optional) Vortex mixer Optional, for TaqMan configuration Optional for all configurations Page 15 of 15 See web link to reports containing data at s_laboratory/evaluations/pq_list/en/index.html Not Applicable