PQDx 0221-046-00 WHO PQDx PR January/2016, version 2.
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® TaqMan® HIV-1 Qualitative Test, version 2.0 (TaqMan 48)
with product codes 06693083190, 03051315001, 03279332001, 03587797190,
06989861190, 05807875001, 03516440001, and 28127387001, 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 2014.
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
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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,
06693083190
COBAS® AmpliPrep/COBAS® TaqMan® Wash Reagent, 03587797190
COBAS® AmpliPrep/COBAS® TaqMan® Specimen Pre-Extraction Reagent,
06989861190
Instrumentation:
COBAS® TaqMan® 48 Analyzer, 03279332001
COBAS® AmpliPrep Instrument, 03051315001
Software and Hardware:
AMPLILINK Software, Version 3.3 Series or higher, 05807875001
XP Data Station for AMPLILINK S/W with Printer, 03516440001
Optional:
cobas p 630 instrument, 05527503001
Disposables (Not provided):
• Sample processing units (SPUs), 03755525001
• Sample input tubes (S-tubes) with barcode clips, 03137040001
• Racks of K-tips, 03287343001
• K-tube (Box of 12 x 96), 03137082001
• Sample rack (SK 24 rack), 028122172001
• Reagent rack, 028122199001
• SPU rack, 05471664001
• K-tube capper, motorized, 03516539001
• K-tube capper, 03339874001
• K-carrier, 03341488001
• K-carrier transporter, 03517519001
• K-carrier rack, 03286436001
Other materials required but not provided:
XP Data Station for the AMPLILINK S/W with printer, 03516440001
Docking Station Short, 28127387001
Pipettors with aerosol barrier or positive displacement RNase-free tips (capacity
1000 μL)
Disposable gloves, powderless
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Vortex mixer
Storage:
COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, version 2.0, 06693083190,
should be stored at 2°C to 8°C.
COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 03587797190, should be stored at
2°C to 30°C.
COBAS® AmpliPrep/COBAS® TaqMan® Specimen Pre-Extraction Reagent, 06989861190,
should be stored at 2°C to 8°C.
Shelf-life:
COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Qualitative Test, version 2.0, 06693083190:
22 months
COBAS AmpliPrep/COBAS TaqMan Wash Reagent, 03587797190: 24 months
COBAS® AmpliPrep/COBAS® TaqMan® Specimen Pre-Extraction Reagent 06989861190: 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.
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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.
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Labelling
1. Labels
2. Instructions for use
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1. Labels
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2. Instructions for use
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