Initial sensitivity: 100% Final specificity: 98% Initial sensitivity: 99%
|
|
- Teresa Gallagher
- 5 years ago
- Views:
Transcription
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%
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
More informationInitial sensitivity: 99% Initial sensitivity: 100% Final specificity: 98% Final specificity: 98%
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
More informationList 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,
More informationWHO list of prequalified in vitro diagnostic products
WHO list of in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 8 April 2016 Year 2016 HIV RDT OraQuick
More informationWHO list of prequalified in vitro diagnostic products
WHO list of prequalified in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 17 March 2017 Year
More informationWHO list of prequalified in vitro diagnostic products
WHO list of in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 21 December 2016 Year 2016 HIV RDT
More informationWHO list of prequalified in vitro diagnostic products
WHO list of prequalified in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 22 December Year prequalified
More informationWHO list of prequalified in vitro diagnostic products
: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2018 CD4 Muse Auto CD4/CD4% kit MCA100101, MCA500101, MCA1XK101 EMD Millipore Corporation
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) Number: PQDx 0221-046-00 Abstract COBAS AmpliPrep/COBAS
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 96) Number: PQDx 0200-046-00 Abstract COBAS AmpliPrep/COBAS
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx 0145-027-00 Abstract Abbott RealTime HIV-1 (m2000sp) assay with product code 2G31, which
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 48) Number: PQDx 0126-046-00 Abstract The COBAS AmpliPrep/COBAS TaqMan
More informationWHO list of prequalified in vitro diagnostic products
2018 CD4 CyFlow Counter System with CD4 easy count kit and CD4% easy count kit CY-S-3022, 05-8401, 05-8405 ed Sysmex Partec GmbH Arndtstr. 11a-b, 02826 Görlitz, Germany; and Exbio Praha a.s., Nad Safinou
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx 0145-027-00 Abstract The Abbott RealTime HIV-1 (m2000sp) assay with product code 2G31 (which
More informationConsolidated Donor Funded Procurement of HIV Diagnostics
Consolidated Donor Funded Procurement of HIV Diagnostics Meeting on HIV Diagnostic Global Demand Forecast Geneva, 9 April 2015 Mercedes Perez Gonzalez Prequalification Team Diagnostics Assessment Department
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: VERSANT HIV-1 RNA 1.0 Assay (kpcr) Number: PQDx
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: VERSANT HIV-1 RNA 1.0 Assay (kpcr) Number: PQDx 0115-041-00 Abstract The VERSANT HIV-1 RNA 1.0 Assay (kpcr) with product codes 10375763,
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: Alere HIV Combo WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: Alere HIV Combo WHO reference number: PQDx 0243-013-00 Alere HIV Combo with product codes 7D2842, 7D2843, 7D2843SET manufactured by Alere
More informationList of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy
Version 18 28 March 2018 List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy According to Global Fund Quality Assurance Policy for Diagnostic
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device Number: PQDx 0141-051-00 Abstract ABON HIV 1/2/O Tri-Line Human
More informationList of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy
Version 21 26 Oct 2018 List of HIV Diagnostic test kits and equipments classified according to the Global Fund Quality Assurance Policy According to Global Fund Quality Assurance Policy for Diagnostic
More informationUpdate on WHO Prequalification of IVDs
Update on WHO Prequalification of IVDs Geneva, 11 March 2016 Mercedes Perez Gonzalez Anita Sands Prequalification Team - Diagnostics World Health Organization Outline Progress and Pipeline Ongoing concerns
More informationWHO Prequalification of In Vitro Diagnostics Programme
WHO Prequalification of In Vitro Diagnostics Programme International HIV/Viral Hepatitis Co-Infection Satellite Meeting 19 July 2014, Melbourne Anita Sands Prequalification Diagnostics Team Department
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: OraQuick HCV Rapid Antibody Test Kit WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: OraQuick HCV Rapid Antibody Test Kit WHO reference number: PQDx 0244-055-00 OraQuick HCV Rapid Antibody Test Kit with product codes 1001-0270
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: First Response HIV Card Test Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: First Response HIV 1-2-0 Card Test Number: PQDx 0018-010-00 Abstract First Response HIV 1-2-0 Card Test with product codes
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx 0159-055-00 OraQuick HIV 1/2 Rapid Antibody Test with product codes 5x4-0010
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: OraQuick HIV 1/2 Rapid Antibody Test WHO reference number: PQDx 0159-055-00 OraQuick HIV 1/2 Rapid Antibody Test with product codes 5x4-0010
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: SD BIOLINE HCV WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: SD BIOLINE HCV WHO reference number: PQDx 0257-012-00 SD BIOLINE HCV with product code 02FK10, manufactured by Standard Diagnostics,
More informationInfectious Disease Testing. ULTRA Product Line. Safety is not a Matter of Chance
Infectious Disease Testing ULTRA Product Line Safety is not a Matter of Chance ULTRA Product Line The best answer for HBV, HCV and HIV screening: a global automated solution for safe results. Monolisa
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Uni-Gold HIV Number: PQDx Abstract
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Uni-Gold HIV Number: PQDx 0149-052-00 Abstract Uni-Gold HIV with product codes 1206502, 1206502N, 1206502E, 1206502N-100 manufactured
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: SURE CHECK HIV 1/2 Assay Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: SURE CHECK HIV 1/2 Assay Number: PQDx 0054-006-00 Abstract SURE CHECK HIV 1/2 Assay with product code HIV201, manufactured
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: INSTI HIV-1/HIV-2 Antibody Test Number: PQDx
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: INSTI HIV-1/HIV-2 Antibody Test Number: PQDx 0002-002-00 Abstract INSTI HIV-1/HIV-2 Antibody Test with product codes, 90-1013, 90-1010,
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Murex HIV Ag/Ab Combination Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Murex HIV Ag/Ab Combination Number: PQDx 0144-043-00 Abstract Murex HIV Ag/Ab Combination with product codes 7G79-09 (GE41,
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Uni-Gold HIV Number: PQDx Abstract
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Uni-Gold HIV Number: PQDx 0149-052-00 Abstract Uni-Gold HIV with product codes 1206502, 1206502N, 1206502E, 1206502N-100 manufactured
More information100 Abbott Park Road Abbott Park, IL Trade Name: ARCHITECT HIV Ag/Ab Combo Assay Approved Date: 18-JUN-2010
Currently Approved CBER Device Premarket Applications (PMAs) As of Nov 10, 2014 Sorted by Applicant Name BP090080-0 BP060002-0 BP120037-0 BP090022-0 BP090032-0 BP040046-0 BP100064-0 BP140120-0 Abbott Laboratories
More informationDraft Report WHO evaluation of HIV 1/2 STAT-PAK (Chembio Diagnostic Systems Inc)
Date: 6 January 2012 Draft Report WHO evaluation of HIV 1/2 STAT-PAK (Chembio Diagnostic Systems Inc) WHO Collaborating Centre for HIV/AIDS Diagnostic and Laboratory Support Department of Clinical Sciences
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: DPP HIV 1/2 Assay WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: DPP HIV 1/2 Assay WHO reference number: PQDx 0053-006-00 DPP HIV 1/2 Assay with product code 65-9506-0, manufactured by Chembio Diagnostic
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Enzygnost HIV Integral 4 WHO reference number: PQDx
PQDx 0214-064-00 WHO PQDx PR April/2016, version 3.0 WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Enzygnost HIV Integral 4 WHO reference number: PQDx 0214-064-00 Enzygnost
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Alere Determine HIV-1/2 Number: PQDx Abstract
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Alere Determine HIV-1/2 Number: PQDx 0033-013-00 Abstract The Alere Determine HIV-1/2 with product codes 1 7D2342, 7D2343 and 7D2243
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Alere HIV/Syphilis Duo Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Alere HIV/Syphilis Duo Number: PQDx 0179-012-00 Abstract Alere HIV/Syphilis Duo with product codes 06FK30 and 06FK35, manufactured
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: HIV 1/2 STAT-PAK Number: PQDx Abstract
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: HIV 1/2 STAT-PAK Number: PQDx 0007-006-00 Abstract The HIV 1/2 STAT-PAK with product code HIV101, manufactured by Chembio Diagnostic
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: BD FACSCount Instrument System with FACSCount Control Kit and BD FACSCount Reagent Kit (Absolute CD4+, CD8+, and CD3+ Counts) Number:
More informationNEW CHALLENGES FOR ACCURATE HIV-1 DIAGNOSIS ALL BELGIAN AIDS REFERENCE LABORATORIES KAROLIEN STOFFELS (ARL VUB STP) & FIEN VANROYE (ARL ITM)
NEW CHALLENGES FOR ACCURATE HIV-1 DIAGNOSIS ALL BELGIAN AIDS REFERENCE LABORATORIES KAROLIEN STOFFELS (ARL VUB STP) & FIEN VANROYE (ARL ITM) 30 NOVEMBER 2018, BRUGGE 0 NEW CHALLENGES FOR ACCURATE HIV-1
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Pima CD4 Test Number: PQDx Abstract
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Pima CD4 Test Number: PQDx 0099-032-00 Abstract The Pima TM CD4 Test with product codes 260100100, 260100025 and 260300001 1, manufactured
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx
PQDx 0145-027-00 WHO PQDx Public Report August/2017, version 7.0 WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Abbott RealTime HIV-1 (m2000sp) Number: PQDx 0145-027-00 Abstract Abbott
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Murex HBsAg Version 3 with Murex HBsAg Confirmatory Version 3 Number: PQDx 0121-043-00 Abstract Murex HBsAg Version 3 with Murex HBsAg
More informationInstructions for Use. RealStar Influenza Screen & Type RT-PCR Kit /2017 EN
Instructions for Use RealStar Influenza Screen & Type RT-PCR Kit 4.0 05/2017 EN RealStar Influenza Screen & Type RT-PCR Kit 4.0 For research use only! (RUO) 164003 INS-164000-EN-S01 96 05 2017 altona
More informationInstructions for Use. RealStar Influenza S&T RT-PCR Kit /2017 EN
Instructions for Use RealStar Influenza S&T RT-PCR Kit 3.0 01/2017 EN RealStar Influenza S&T RT-PCR Kit 3.0 For research use only! (RUO) 163003 INS-163000-EN-S02 96 01 2017 altona Diagnostics GmbH Mörkenstr.
More informationAdvantages and disadvantages of different types of FDA-approved HIV immunoassays used for screening by generation and platform*
Advantages and disadvantages of different types of FDA-approved HIV immunoassays used for screening by generation and platform* HIV immunoassays grouped by generation, platform, and CLIA complexity + Advantages
More informationAccuVert HIV-1 Seroconversion Panel PRB974 ( )
PACKAGE INSERT PRB974 (0600-0258) INTENDED USE PRB974 (0600-0258) is a group of serial bleeds from an individual plasma donor during seroconversion. This panel is intended for use by diagnostics manufacturers
More informationHIV-1 Seroconversion Panel PRB973
A SERACARE PANEL PRODUCT INTENDED USE The is a group of serial bleeds from an individual plasma donor during seroconversion. This panel is intended for use by diagnostics manufacturers and clinical laboratorians
More information2018 HIV and HCV Diagnostic Testing Survey
2018 HIV and HCV Diagnostic Testing Survey This survey is designed to capture the 2017 HIV and HCV testing practices in state and local public health laboratories (PHL). The results of the survey will
More informationSimple Solutions for Patient Monitoring. Maximum Flexibility 2 Configuration: 8 to 1000 viral load tests/day 2 Sample: Plasma/DBS
Simple Solutions for Patient Monitoring What is the interest of having a high level of sensitivity? Higher sensitivity means you are able to offer better patient monitoring, particularly in the low viral
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: Alere q HIV-1/2 Detect WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: Alere q HIV-1/2 Detect WHO reference number: PQDx 0226-032-00 Alere q HIV-1/2 Detect with product codes 270110050, 270110010 and 270300001,
More informationaltona RealStar Instructions for Use RealStar CMV PCR Kit /2017 EN DIAGNOSTICS
altona DIAGNOSTICS Instructions for Use RealStar CMV PCR Kit 1.2 08/2017 EN RealStar RealStar CMV PCR Kit 1.2 For research use only! (RUO) 021202 INS-021200-EN-S01 48 08 2017 altona Diagnostics GmbH Mörkenstr.
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Enzygnost HBsAg 6.0 WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Enzygnost HBsAg 6.0 WHO reference number: PQDx 0173-064-00 Enzygnost HBsAg 6.0 with product codes OPFM03, OPFM05, OPFM07(Q)
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: First Response HIV Card Test Number: PQDx
PQDx 18-1- WHO PQDx PR July/216, version 3. WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: First Response HIV 1-2- Card Test Number: PQDx 18-1- Abstract First Response HIV
More informationSP.718 Special Topics at Edgerton Center: D-Lab Health: Medical Technologies for the Developing World
MIT OpenCourseWare http://ocw.mit.edu SP.718 Special Topics at Edgerton Center: D-Lab Health: Medical Technologies for the Developing World Spring 2009 For information about citing these materials or our
More informationMouse HBsAg(Hepatitis B Virus Surface Antigen) ELISA Kit
Mouse HBsAg(Hepatitis B Virus Surface Antigen) ELISA Kit Catalogue No.: EM0002 Size: 96T Reactivity: Mouse Application: This immunoassay kit allows for the qualitative determination of HBsAg in Mouse serum
More informationRoche Molecular Biochemicals Application Note No. HP 1/1999
Roche Molecular Biochemicals Application Note No. HP 1/1999 Nucleic Acid Purification High Pure Viral Nucleic Acid Kit High Pure 16 System Viral Nucleic Acid Kit Efficiency of Hepatitis C Virus sample
More informationSOLE-SOURCE DETERMINATION
SOLE-SOURCE DETERMINATION The Purchasing Division has been requested to approve a sole source purchase for the commodity or service described below. Pursuant to West Virginia Code 5A-3-10c, the Purchasing
More information1 st and 2 nd Generation EIA
HIV Diagnostic Tests Bernard M. Branson, M.D. Associate D irector for Laboratory D iagnostics Division of HIV/AIDS Prevention Centers for D isease Control & Prevention The views expressed in this presentation
More informationHIV Serology Quality Assessment Program Summary for Panel HIVSER 2017Apr19
National Laboratory for HIV Reference Services National HIV and Retrovirology Laboratories National Microbiology Laboratory Public Health Agency of Canada HIV Serology Quality Assessment Program Summary
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Bioelisa HIV 1+2 Ag/Ab Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Bioelisa HIV 1+2 Ag/Ab Number: PQDx 0183-060-00 Abstract Bioelisa HIV 1+2 Ag/Ab with product codes 3000-1172 and 300-1173,
More informationTHE AVAILABILITY AND USE OF HIV DIAGNOSTICS: A 2012/2013 WHO SURVEY IN LOW-AND MIDDLE-INCOME COUNTRIES TECHNICAL REPORT
TECHNICAL REPORT AIDS MEDICINES AND DIAGNOSTICS SERVICE THE AVAILABILITY AND USE OF HIV DIAGNOSTICS: A 2012/2013 WHO SURVEY IN LOW-AND MIDDLE-INCOME COUNTRIES DECEMBER 2014 THE AVAILABILITY AND USE OF
More informationNew HIV Tests and Algorithm: A change we can believe in
New HIV Tests and Algorithm: A change we can believe in Esther Babady, PhD, D (ABMM) Memorial Sloan-Kettering Cancer Center New York, New York Learning Objectives After this presentation you should be
More informationRat C-peptide ELISA. For the quantitative determination of C-peptide in rat serum
Rat C-peptide ELISA For the quantitative determination of C-peptide in rat serum Please read carefully due to Critical Changes, e.g., see Calculation of Results. For Research Use Only. Not For Use In Diagnostic
More informationANNEX 8: Ensuring the quality of HIV testing services
ANNEX 8: Ensuring the quality of HIV testing services Acknowledgement: Sands, A 1 8.1 WHO Prequalification of In Vitro Diagnostics Programme The WHO Prequalification of in Vitro Diagnostics Programme is
More informationInsulin (Porcine/Canine) ELISA
Insulin (Porcine/Canine) ELISA For the quantitative measurement of insulin in Porcine/Canine serum and plasma (EDTA) For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: 80-INSPO-E01
More informationCEPHIA Consortium for the Evaluation and Performance of HIV Incidence Assays STANDARD OPERATING PROCEDURE
CEPHIA Consortium for the Evaluation and Performance of HIV Incidence Assays STANDARD OPERATING PROCEDURE TITLE : SOP for (off board dilution) Less Sensitive Modified VITROS Enzyme Immunoassay CEPHIA DOCUMENT
More informationThe first and only fully-automated, multiplexed solution for Measles, Mumps, Rubella and Varicella-zoster virus antibody testing
Bio-Rad Laboratories BioPlex 2200 System BioPlex 2200 MMRV IgG Kit The first and only fully-automated, multiplexed solution for Measles, Mumps, Rubella and Varicella-zoster virus antibody testing Bio-Rad
More informationPoint-of-care HIV testing
Point-of-care HIV testing Joanne Stekler, MD MPH Associate Professor University of Washington December 5, 2016 Disclaimer: The findings and conclusions in this presentation are those of the author(s) and
More informationScreening and Diagnosis of Hepatitis Virus Infections
Screening and Diagnosis of Hepatitis Virus Infections Prof. Jean-Michel Pawlotsky, MD, PhD National Reference Center for Viral Hepatitis B, C and delta Department of Virology & INSERM U955 Henri Mondor
More informationAccuSet HIV-1/2 Performance Panel
OVERVIEW AccuSet HIV-1/2 (0800-0380) is a 13-member validation panel of undiluted, naturally occurring plasma samples (1 vial per member, 1.0 ml per vial). Panel members represent bleeds from multiple
More informationEvolution of HIV Diagnostics. Goals for the 2010 Conference. Bernard M. Branson, M.D. CDC Division of HIV/AIDS Prevention
Evolution of HIV Diagnostics and Goals for the 2010 Conference Bernard M. Branson, M.D. Associate Director for Laboratory Diagnostics CDC Division of HIV/AIDS Prevention Evolution or other influences like
More informationAbbott RealTime HIV-1
E RealTime HIV-1 6L18 51-602146/R2 Abbott RealTime HIV-1 Customer Service: 1-800-553-7042 This package insert must be read carefully prior to use. Package insert instructions must be followed accordingly.
More informationDiagnostic Methods of HBV infection. Zohreh Sharifi,ph.D of Virology Research center, Iranian Blood Transfusion Organization (IBTO)
Diagnostic Methods of HBV infection Zohreh Sharifi,ph.D of Virology Research center, Iranian Blood Transfusion Organization (IBTO) Hepatitis B-laboratory diagnosis Detection of HBV infection involves
More informationInsulin ELISA. For the quantitative determination of insulin in serum and plasma
Insulin ELISA For the quantitative determination of insulin in serum and plasma For In Vitro Diagnostic use within the United States of America. This product is for Research Use Only outside of the United
More informationRealLine HBV / HCV / HIV Str-Format
Instructions for use ASSAY KIT FOR THE QUALITATIVE AND DIFFERENTIAL DETECTION OF HEPATITIS B VIRUS DNA, HEPATITIS C VIRUS RNA, AND HUMAN IMMUNODEFICIENCY VIRUS TYPES 1 AND 2 RNA USING THE PCR/RT-PCR METHOD
More informationBovine Insulin ELISA
Bovine Insulin ELISA For quantitative determination of insulin in bovine serum and plasma. For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: 80-INSBO-E01 Size: 96 wells Version:
More informationRat C-peptide ELISA. For the quantitative determination of C-peptide in rat serum. For Research Use Only. Not For Use In Diagnostic Procedures.
Rat C-peptide ELISA For the quantitative determination of C-peptide in rat serum. For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: Size: 80-CPTRT-E01 96 wells Version: May 26,
More informationRat Insulin ELISA. For the quantitative determination of insulin in rat serum and plasma. For Research Use Only. Not For Use In Diagnostic Procedures.
Rat Insulin ELISA For the quantitative determination of insulin in rat serum and plasma For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: Size: 80-INSRT-E01, E10 96 wells, 10
More informationHIV-1 Seroconversion Panel PRB975
Seroconversion OVERVIEW is a five member HIV Seroconversion collected from a single donor over a 14 day period in 2002, prior to antibody seroconversion. -03 is a challenging sample for HIV RNA assays,
More informationMP Biomedicals Asia Pacific Pte. Ltd. (formerly Genelabs Diagnostics Pte. Ltd.)
Revision: 12 May 2005 1 WESTERN BLOT / IMMUNOBLOT HIV-1 BLOT Version 1.3* 11010-018 HIV-1 viral lysate Western Blot assay for the 11010-036 detection of antibodies to HIV-1 with serum 11010-108 108 strips
More informationFor purification of viral DNA and RNA from a wide range of sample materials
QIAamp virus kits For purification of viral DNA and RNA from a wide range of sample materials Automatable on QIAGEN s proven QIAamp Kits set the standard for purification of viral DNA and RNA. QIAamp virus
More informationPorcine/Canine Insulin ELISA
Porcine/Canine Insulin ELISA For the quantitative determination of insulin in porcine or canine serum and plasma. Please read carefully due to Critical Changes, e.g., Calculation of Results. For Research
More informationRat Proinsulin ELISA
Rat Proinsulin ELISA For the quantitative determination of proinsulin in rat serum For Research Use Only. Not For Use In Diagnostic Procedures. Catalog Number: 80-PINRT-E01 Size: 96 wells Version: June
More informationTAP HERE TO SEE THE PRODUCT
TAP HERE TO SEE THE PRODUCT Make every testing opportunity count. Acute infection accounts for 5-20% of all cases of HIV infection among persons seeking testing.1 This acute phase of infection is associated
More informationMouse C-peptide ELISA
Mouse C-peptide ELISA For the quantitative determination of C-peptide in mouse serum. For Research Use Only. Not for use in Diagnostic Procedures. Please read carefully due to Critical Changes, e.g., Preparation
More informationMouse Ultrasensitive Insulin ELISA
Mouse Ultrasensitive Insulin ELISA For the quantitative determination of insulin in mouse serum and plasma. Please read carefully due to Critical Changes, e.g., Calculation of Results. For Research Use
More informationInsulin ELISA. For the quantitative determination of insulin in serum and plasma.
Insulin ELISA For the quantitative determination of insulin in serum and plasma. For In Vitro Diagnostic use within the United States of America. This product is for Research Use Only outside of the United
More informationHIV-1 AccuVert TM Seroconversion Panel
PACKAGE INSERT PRB954 (0600-0238) INTENDED USE The is intended for use by diagnostic manufacturers, researchers, and clinical laboratories to develop, evaluate, or troubleshoot test methods. Characterized
More informationWHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT. Product: Murex anti-hcv (version 4.0) Number: PQDx
WHO Prequalification of In Vitro Diagnostics Programme PUBLIC REPORT Product: Murex anti-hcv (version 4.0) Number: PQDx 0164-059-00 Abstract Murex anti-hcv (version 4.0) with product codes 7F51-01 and
More informationMouse C-peptide ELISA
Mouse C-peptide ELISA For the quantitative determination of C-peptide in mouse serum. For Research Use Only. Not for use in Diagnostic Procedures. Please read carefully due to Critical Changes, e.g., Calculation
More informationWHO Prequalification of In Vitro Diagnostics PUBLIC REPORT. Product: OraQuick HIV Self-Test WHO reference number: PQDx
WHO Prequalification of In Vitro Diagnostics PUBLIC REPORT Product: OraQuick HIV Self-Test WHO reference number: PQDx 0159-055-01 OraQuick HIV Self-Test with product codes 5X4-1000 and 5X4-1001 manufactured
More informationRealLine HIV quantitative Str-Format
Instructions for use DETECTION AND QUANTIFICATION OF THE HUMAN IMMUNODEFICIENCY VIRUS RNA BY REAL TIME PCR Research Use Only (RUO) Attention! Please read the information about quantification process carefully!
More informationHuman HIV (1+2) antigen&antibody ELISA Kit
Human HIV (1+2) antigen&antibody ELISA Kit Catalog Number. CSB-E18042h For the qualitative determination of human HIV (1+2) antibody and P24 antigen concentrations in serum, plasma. This package insert
More informationAbbott RealTime HBV. Note Changes Highlighted 2G /R2. Customer Service International: Call your Abbott Representative
Abbott RealTime HBV E 2G34 51-602150/R2 Note Changes Highlighted Customer Service International: Call your Abbott Representative This package insert must be read carefully prior to use. Package insert
More informationWHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Bioelisa HCV 4.0 Number: PQDx Abstract
WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Bioelisa HCV 4.0 Number: PQDx 0165-060-00 Abstract Bioelisa HCV 4.0 with product codes 3000-1115 and 3000-1116, manufactured by Biokit
More informationAlere Technologies GmbH
Alere Technologies GmbH Mobile Smart Instruments for Automated Image Analysis and Point of Care Diagnosis April 2011 Alere Technologies GmbH Alere Technologies GmbH Based in Jena, Thuringia, Germany ~300
More informationAccuSet HCV Performance Panel
Signal to cutoff (s/co) DATA SHEET OVERVIEW AccuSet HCV (0810-0204) is a 25-member validation panel of undiluted, naturally occurring plasma samples (1 vial per member, 1.0 ml per vial). Panel members
More information