WHO Prequalification of Diagnostics Programme PUBLIC REPORT
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1 WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) Number: PQDx Abstract COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) with product codes , , , , , , , and , manufactured by Roche Diagnostics GmbH, CE-marked regulatory version, was accepted for the WHO list of prequalified in vitro diagnostics and was listed on 15 December This public report was amended on 26 January 2016 to reflect a change to the legal manufacturer. The COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 is an in vitro diagnostic, total nucleic acid amplification test for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) DNA and RNA (or total nucleic acid, TNA) in human plasma or dried blood spots using the COBAS AmpliPrep Instrument for automated specimen processing and the COBAS TaqMan Analyzer or COBAS TaqMan 48 Analyzer for automated amplification and detection. The test is a diagnostic test, indicated for individuals who are suspected to be actively infected with HIV-1. Detection of HIV-1 TNA is indicative of active HIV infection. Infants born to mothers infected with HIV-1 may have maternal antibodies to HIV-1, and the presence of HIV-1 nucleic acid in the infant indicates active HIV-1 infection. In adults, the test may be used as an aid in the diagnosis of HIV-1 infection. The COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, v2.0 is an in vitro diagnostic, total nucleic acid amplification test for the qualitative detection of HIV-1 in human EDTA plasma or dried blood spots (DBS) in combination with the COBAS AmpliPrep/COBAS TaqMan Specimen Pre-Extraction Reagent (SPEX). The COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, v2.0 is based on three major processes: (1) specimen preparation to isolate HIV-1 nucleic acids; (2) reverse transcription of target RNA to generate complementary DNA (cdna), and (3) PCR amplification of target DNA and cdna, and simultaneous detection of cleaved dual-labeled oligonucleotide detection probes specific to the target and Internal Control (IC). The workflow is automated using the COBAS AmpliPrep Instrument with the COBAS TaqMan Analyzer Page 1 of 37
2 or the COBAS TaqMan 48 Analyzer. For DBS specimens, a manual pre-extraction step is required. In order to perform the assay, the following components are required: Reagents: COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0, COBAS AmpliPrep/COBAS TaqMan Wash Reagent, COBAS AmpliPrep/COBAS TaqMan Specimen Pre-Extraction Reagent, Instrumentation: COBAS TaqMan 48 Analyzer, COBAS AmpliPrep Instrument, Software and Hardware: AMPLILINK Software, Version 3.3 Series or higher, XP Data Station for AMPLILINK S/W with Printer, Optional: cobas p 630 instrument, Disposables (Not provided): Sample processing units (SPUs), Sample input tubes (S-tubes) with barcode clips, Racks of K-tips, K-tube (Box of 12 x 96), Sample rack (SK 24 rack), Reagent rack, SPU rack, K-tube capper, motorized, K-tube capper, K-carrier, K-carrier transporter, K-carrier rack, Other materials required but not provided: 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) Disposable gloves, powderless Page 2 of 37
3 Vortex mixer Storage: COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0, , should be stored at 2 C to 8 C. COBAS AmpliPrep/COBAS TaqMan Wash Reagent, , should be stored at 2 C to 30 C. COBAS AmpliPrep/COBAS TaqMan Specimen Pre-Extraction Reagent, , should be stored at 2 C to 8 C. Shelf-life: COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0, : 22 months COBAS AmpliPrep/COBAS TaqMan Wash Reagent, : 24 months COBAS AmpliPrep/COBAS TaqMan Specimen Pre-Extraction Reagent : 12 months Summary of prequalification status for COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) Initial acceptance Date Outcome PQ amended 26 January 2016 amended Status on PQ list 15 December 2014 listed Dossier assessment 28 November 2014 MR Inspection status 04 September 2014 MR Laboratory evaluation FT MR MR: Meets Requirements NA: Not Applicable FT: Fast tracked COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) was accepted for the WHO list of prequalified diagnostics on the basis of data submitted and publicly available information. Page 3 of 37
4 Background information The Manufacturersubmitted an application for prequalification of COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48). Based on the established prioritization criteria, COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) was given priority for prequalification. Product dossier assessment The Manufacturer submitted a product dossier for COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) as per the Instructions for compilation of a product dossier (PQDx_018 v1). The information submitted in the product dossier was reviewed by WHO staff and external experts (assessors) appointed by WHO in accordance with the internal report on the screening and assessment of a product dossier (PQDx_009 v2). Based on the product dossier screening and assessment findings, a recommendation was made to accept the product dossier for COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) for prequalification. Manufacturing site inspection A comprehensive inspection was performed at the site of manufacture (Branchburg, New Jersey, USA) of the COBAS AmpliPrep/COBAS TaqMan HIV-1 Quantitative Test, version 2.0 (TaqMan 48), in September 2011 as per the Information for manufacturers on prequalification inspection procedures for the sites of manufacture of diagnostics (PQDx_014 v1). The inspection found that the Manufacturer had an acceptable quality management system and good manufacturing practices in place that ensured the consistent manufacture of a product of good quality. A quality management documentation review was performed in September 2014, and it was established that the Manufacturer continuously implemented a quality management system in compliance with ISO 13485:2003 and that no significant changes were implemented since the first inspection. Laboratory evaluation Given the regulatory version of the product submitted for prequalification and the quality of the data submitted as part of the product dossier to support the claims for its intended use, the COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) assay has been found eligible to undergo the WHO fast track procedure. Subsequently, the product will not be required to undergo a laboratory evaluation. Page 4 of 37
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