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

Size: px

Start display at page:

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

Teresa Gallagher
5 years ago
Views:

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,

1 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 diagnostics@who.int Version 13, 26 August 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. N/A: Not Applicable

2 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-T % 99.7% 24 months/ 7D2342 7D % 99.4% 14 months/ 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 _public_report_abon_h iv_triline_rdt_v1.pdf?ua= _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) 7D % 98.8% 10 months/ % 99.7% 15 months/ 15 to 30 C % 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 , : lancets, alcohol swabs, precision pipette plus tips. If whole : lancets, 20320_0034_013_00_final_p ublic_report_version2.pdf 30829_ _public_report_final_v1.pd f 31212_0150_016_00_public_ report_final_v1.pdf Version 13, 26 August 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. N/A: Not Applicable

3 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) InTec Products Inc. Advanced Quality HIV Rapid Test (Xiamen, PR China) HIV % 100% 24 months/ 8 to 30 C HIV % 99.7% 24 months/ 8 to 30 C ITP TC % 98.8% months/ 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, 20116_0007_006_00_public_ report_final_v1.pdf 11125_0008_006_00_public_ report_final.pdf OraSure Technologies Inc. OraQuick Rapid Antibody Test (Bangkok, Thailand) 5X X % 99.2% 8 months/, oral fluid If whole : lancets, alcohol swabs, additional specimen loops ( ). Orgenics Ltd. Immunocomb II HIV 1 & 2 Bispot (Yavne, Israel) % 99.1% 12 months/ HIV-1 and HIV-2 plasma Not suitable for whole Requires precision pipette plus tips. Page 3 of 13

4 Product code No. of tests Initial sensitivity Final specificity Analyte type HIV Simple Assays/Rapid Diagnostic Tests (RDTs) Premier Medical Corporation Ltd. First Response HIV Card Test (Daman, India) 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) I05FRC % 98.8% 23 months/ 4 to 30 C KH-R % 100% 15 months/ 4 to 30 C 03FK16 03FK10 03FK35 03FK N E % 99.9% 24 months/ 1 to 30 C 100% 99.1% months/ 1 to 30 C % 99.9% 12 months/ 2 to 27 C HIV-1 and HIV-2 detection HIV-1 and HIV-2 and HIV-1 p24 antigen detection If whole : lancets, 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, 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 13

5 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) % 99.2% months/ N/A N/A 12 months/ N/A N/A 11 months/ and HIV-1 p24 antigen HIV-1 and HIV-2 HIV-1 and HIV-2 450/ 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 _ _public_report_final_v1.pd f Page 5 of 13

6 Product code No. of tests Initial sensitivity Final specificity Analyte type HCV Rapid Diagnostic Tests (RDTs) N/A 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) % 100% 10 months/ N/A N/A 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

7 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) 7D % 99.4% 12 months/ 9F F G % 98.3% 12 months/ HBV surface antigen HBV surface antigen Wavelength 450/ 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

8 CD4 Enumeration Technologies Alere Technologies GmbH Pima CD4 Test (Jena, Germany) Product code (instrument) (test kit) No. of tests N/A months (reagent) / type Venous and capillary whole Accessories available. 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) (instrument) (test kit) (control kit) (instrument) (test kit) (control kit) N/A N/A months (reagent), 24 months (control) / 15 months (reagent), 24 months (control) / Venous whole Venous whole N/A N/A ostics_laboratory/evaluati ons/121115_0124_045_00 _public_report_v2_final.p df ostics_laboratory/evaluati ons/121115_0133_045_00 _public_report_v1_final.p df Page 8 of 13

9 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 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 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 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 biomérieux NucliSENS EasyQ HIV- 1 v2.0 (Marcy L Etoile, France) Assay Name, Specific Consumables and Product codes NucliSENS Easy Q HIV-1 V Number of Tests Storage Shelf-life (months) Type Plasma, dried spot (venous whole ) 48T/kit NucliSENS easymag configuration Instrument required for automated only NucliSENS easymag extraction Buffer x1L NucliSENS easymag extraction Buffer x1L NucliSENS easymag extraction Buffer x1L NucliSENS Magnetic Extraction Reagent Required for semi-automated only T/kit NucliSENS Lysis Buffer (2ml) T/kit 24 Required for semi-automated only NucliSENS easymag extraction Lysis 24 Buffer x1L NucliSENS easymag magnetic silica x1L NucliSENS minimag configuration Instrument required for semi-automated only NucliSENS Easy Q configuration Instrument required for both configurations (automated and semiautomated) Mini Strip Centrifuge Required for both configurations (automated and semi-automated) Promega Magnetic Rack 12 holes Required for semi-automated only Micro Tubes 1.5 ml with caps Required for semi-automated only Biohit Tips EasyMAG disposables Required for both configurations (automated and semi-automated) Strip Plates Greiner EasyQ 8-Tube Caps Required for both configurations (automated and semi-automated) EasyQ 8-Tube Strips Required for both configurations (automated and semi-automated) For a full list of consumables required, see WHO Public Reports For the automated diagnostics_laborato ry/evaluations/ _0127_016_00_pu blic_report_v1.pdf For the semiautomated diagnostics_laborato ry/evaluations/ _0148_016_00_pu blic_report_v1.pdf Page 10 of 13

11 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, COBAS AmpliPrep/COBAS TaqMan Wash Reagent Number of Tests 48T/kit 5.1L Storage 2 to 30 C Shelf-life (months) 24 type Plasma COBAS TaqMan 48 Analyzer Instrument required for TaqMan 48 only COBAS Ampliprep Instrument COBAS TaqMan Analyzer Required for TaqMan 96 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 96 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 13

12 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 (Instrument VERSANT Sample Preparation 1.0 Reagents, IVDD (Box 1), T/kit 15 to 30 C 24 VERSANT Sample Preparation 1.0 Reagents, IVDD (Box 2), T/kit 24 VERSANT HIV-1 RNA Assay 1.0 (kpcr), IVDD (Box -30 to - 1), T/kit 10 C 12 VERSANT HIV-1 RNA Assay 1.0 (kpcr) IVDD (Box 2), -90 to T/kit 60 C 12 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, 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

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 4N 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 Combined Application CD ROM 4N66-01 or higher 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 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 13

For further information about this list including pricing, contact by Sensitivity: 99%

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