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 Test, version 2.0 (TaqMan 48) Number: PQDx Abstract The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 48) with product codes and , manufactured by Roche Molecular Systems, Inc., CE-marked regulatory version, was accepted for the WHO list of prequalified diagnostics and was listed on 01 May This version of the product is intended to be used in conjunction with the following instruments/software: , , or Optional: The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (v2.0) is an in vitro nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma 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 can quantitate HIV-1 RNA over the range of 20-10,000,000 copies/ml. One copy of HIV-1 RNA is equivalent to 1.7 ± 0.1 International Units (IU) based on the WHO 1st International Standard for HIV-1 RNA for Nucleic Acid-Based Techniques (NAT) (NIBSC 97/656). This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 group M and HIV-1 group O infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment. The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 is not intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection. The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 is a nucleic acid amplification test for the quantitation of Human Immunodeficiency Virus Type 1 (HIV-1) RNA in human plasma. The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 is based on three major processes: (1) specimen preparation to isolate HIV-1 RNA; (2) reverse transcription of the target RNA to generate complementary DNA (cdna), and (3) simultaneous PCR PQDx_107 Page 1 of 64
2 amplification of target cdna and detection of cleaved dual-labeled oligonucleotide detection probe specific to the target. The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, v2.0 permits automated specimen preparation followed by automated reverse transcription, PCR amplification and detection of HIV-1 target RNA and HIV-1 Quantitation Standard (QS) Armored RNA. The Master Mix reagent contains primers and probes specific for both HIV-1 RNA and HIV-1 QS RNA. The Master Mix has been developed to ensure equivalent quantitation of group M subtypes of HIV-1 and of HIV-1 group O. The detection of amplified DNA is performed using targetspecific and QS-specific dual-labeled oligonucleotide probes that permit independent identification of HIV-1 amplicon and HIV-1 QS amplicon. The quantitation of HIV-1 viral RNA is performed using the HIV-1 QS. It compensates for effects of inhibition and controls the preparation and amplification processes, allowing a more accurate quantitation of HIV-1 RNA in each specimen. The HIV-1 QS is a noninfectious Armored RNA construct that contains HIV sequences with identical primer binding sites as the HIV-1 target RNA and a unique probe binding region that allows HIV-1 QS amplicon to be distinguished from HIV-1 target amplicon. The HIV-1 QS is added to each specimen at a known copy number and is carried through the subsequent steps of specimen preparation, reverse transcription, simultaneous PCR amplification and detection of cleaved dual-labeled oligonucleotide detection probes. The COBAS TaqMan Analyzer or COBAS TaqMan 48 Analyzer calculates the HIV-1 RNA concentration in the test specimens by comparing the HIV-1 signal to the HIV-1 QS signal for each specimen and control. In order to perform the assay, the following components are required: Reagents: COBAS AmpliPrep/COBAS TaqMan HIV 1 Test version 2.0, COBAS AmpliPrep/COBAS TaqMan Wash Reagent Instrumentation: COBAS TaqMan 48 Analyzer COBAS Ampliprep Instrument Software: AMPLILINK Software, Version 3.2 Series or AMPLILINK Software, Version 3.3 Series Optional: cobas p 630 instrument PQDx_107 Page 2 of 64
3 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 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: Data Station for the AMPLILINK software, with printer Pipettors with aerosol barrier or positive displacement RNase-free tips (capacity 1000 μl) Disposable gloves, powderless Vortex mixer Storage: The COBAS AmpliPrep/COBAS TaqMan HIV 1 Test version 2.0, , should be stored at 2 C to 8 C. The COBAS AmpliPrep/COBAS TaqMan Wash Reagent, , should be stored at 2 C to 30 C. Shelf-life: COBAS AmpliPrep/COBAS TaqMan HIV 1 Test version 2.0, : 18 months. COBAS AmpliPrep/COBAS TaqMan Wash Reagent, : 24 months. PQDx_107 Page 3 of 64
4 Summary of prequalification status for COBAS AmpliPrep / COBAS TaqMan HIV- 1 Test, version 2.0 (TaqMan 48) Initial acceptance Date Outcome Status on PQ list 01 May 2012 listed Dossier assessment 06 March 2012 MR Inspection status 15 March 2012 MR Laboratory evaluation FT MR MR: Meets Requirements NA: Not Applicable FT: Fast-tracked COBAS AmpliPrep/COBAS TaqMan HIV-1 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. Background information Roche Molecular Systems, Inc. submitted an application for prequalification of COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 48). Based on the established prioritization criteria, COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 48) was given priority for prequalification. Product dossier assessment Roche Molecular Systems, Inc. submitted a product dossier for COBAS AmpliPrep/ COBAS TaqMan HIV-1 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 Test, version 2.0 (TaqMan 48) for prequalification. Commitments for prequalification: The manufacturer has amended and submitted additional documentation as per the product dossier assessment findings. No further amendments are required. Manufacturing site inspection PQDx_107 Page 4 of 64
5 An inspection was performed at the site of manufacture (1080 US Hwy 202 South, Branchburg, NJ , USA) of the COBAS AmpliPrep/-COBAS TaqMan HIV-1 Test v2.0 on 26,27 September 2011 as described in Information for manufacturers on WHO prequalification inspection procedures for the sites of manufacture of diagnostics (PQDx_014 v1). The fast track inspection found that the manufacturer had a well-established quality management system and manufacturing practices in place that would ensure the manufacture of product of consistent quality. The manufacturer s response to the inspection findings was accepted, and the inspection thus finalized, on 15 March Commitment for prequalification: Roche Molecular Systems, Inc. will continue to work towards further assisting end users in challenging work environments. This includes on-going relevant risk assessment, assuring appropriate transportation of product, and improving communication (e.g. customer feedback mechanisms) for users in these resource limited regions where such communication may be problematic. 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 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 for its use with human plasma. Nevertheless, taking into consideration the needs of WHO Member States and in an effort to support current attempts to increase access to HIV Viral Load testing, a laboratory evaluation of the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 48) will be carried out to assess its performance with the use of Dried Blood Spots (DBS). It is acknowledged that this constitutes an off-label use of the product and therefore, results from the evaluation will not impact the WHO Prequalification status for use with human plasma. The results from the evaluation will serve as a source of information in order to advise WHO Member States in their efforts to scale up HIV Viral Load Testing. PQDx_107 Page 5 of 64
6 Labelling 1. Labels 2. Instructions for use PQDx_107 Page 6 of 64
7 1. Labels 1.1 COBAS AmpliPrep/COBAS TaqMan HIV-1 Test Kit Carton PQDx_107 Page 7 of 64
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13 1.2 Insert License Novartis HIV/HCV PQDx_107 Page 13 of 64
14 1.3 Export Only Label PQDx_107 Page 14 of 64
15 1.4 Insert Product Info Card PQDx_107 Page 15 of 64
16 1.4.1 HIV-1 v2.0 CS1 (HIV-1 v2.0, Magnetic Glass Particles Reagent Cassette) PQDx_107 Page 16 of 64
17 1.4.2 HIV-1 CS2 (HIV-1 v2.0, Lysis Reagent) PQDx_107 Page 17 of 64
18 1.4.3 HIV-1 v2.0 CS3 (HIV-1 v2.0, Multi-Reagent Cassette) PQDx_107 Page 18 of 64
19 1.4.4 HIV-1 v2.0 CS4 (HIV-1 v2.0, Test-Specific Reagent Cassette) PQDx_107 Page 19 of 64
20 1.4.5 Quantitation Standard Vial Label Master Mix Vial Label Manganese Vial PQDx_107 Page 20 of 64
21 1.4.8 HIV-1 H(+)C v2.0 (HIV-1 v2.0, High Positive Control) PQDx_107 Page 21 of 64
22 1.4.9 HIV-1 L(+)C v2.0 (HIV-1 v2.0, Low Positive Control) PQDx_107 Page 22 of 64
23 CTM (-) C [COBAS TaqMan Negative Control (Human Plasma)] PQDx_107 Page 23 of 64
24 High Positive Control Barcode Clip Low Positive Control Barcode Clip PQDx_107 Page 24 of 64
25 Negative Control Barcode Clip 1.5 CD-ROM Test Definition File 48 Tests PQDx_107 Page 25 of 64
26 1.6 COBAS AmpliPrep/COBAS TaqMan Wash Reagent Labels PQDx_107 Page 26 of 64
27 2. Instructions for use PQDx_107 Page 27 of 64
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