WHO Prequalification of Diagnostics Programme PUBLIC REPORT. Product: Abbott RealTime HIV-1 (Manual) Number: PQDx

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1 WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: Abbott RealTime HIV-1 (Manual) Number: PQDx Abstract The Abbott RealTime HIV-1 (Manual) assay with product code 2G31 (which includes 2G31-90, 2G31-80, 2G31-70) manufactured by Abbott Molecular Inc., 1300 East Touhy Avenue, Des Plaines, IL 60018, United States of America, CE-marked regulatory version, was accepted for the WHO list of prequalified diagnostics and was listed on 17 October This version of the product is intended to be used in conjunction with the following instruments/reagents: 9K15-01, 2G31-66, 1L68-09 (or higher), 04J70-24 and 4J The Abbott RealTime HIV-1 (Manual) assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of Human Immunodeficiency Virus type 1 (HIV-1) in human plasma from HIV-1 infected individuals. The Abbott RealTime HIV-1 (Manual) assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. This assay is not intended to be used as a screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection. The Abbott RealTime HIV-1 (Manual) assay uses RT-PCR to generate amplified product from the RNA genome of HIV-1 in clinical specimens. An RNA sequence that is unrelated to the HIV-1 target sequence is introduced into each sample at the beginning of sample preparation. This unrelated RNA sequence is simultaneously amplified by RT-PCR, and serves as an internal control (IC) to demonstrate that the process has proceeded correctly for each sample. The amount of HIV-1 target sequence that is present at each amplification cycle is measured through the use of fluorescent-labeled oligonucleotide probes on the Abbott m2000rt instrument. The amplification cycle at which an increase in fluorescent signal is detected by the Abbott m2000rt is proportional to the log of the HIV-1 RNA concentration present in the original sample. In order to perform the assay, the following components are required: Instrumentation: Abbott m2000rt Instrument 9K15-01 Reagents: m Sample Preparation SystemRNA (4 X 24 Preps) 04J70-24 Page 1 of 48

2 Abbott RealTime HIV-1 2G31 list which includes the following kits: o Abbott RealTime HIV-1 Amplification Reagent Kit (2G31-90), o Abbott RealTime HIV-1 Control Kit (2G31-80) o Abbott RealTime HIV-1 Calibrator Kit (2G31-70) 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 Consumables: 5 ml Reaction Vessels 4J Well Optical Reaction Plates 4J7170 Optical Adhesive Covers 4J7175 Adhesive Cover Applicator 9K3201 Splash-Free Support Base 9K3101 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 Magnetic Stands for 1 x 5 ml Reaction Vessels and 1 x 1.5 ml tubes 2N ml Screw Top Microfuge Tubes and Caps 4J7150 Storage: The Abbott RealTime HIV-1 Calibrator A and Calibrator B must be stored at -10 C or colder. The Abbott RealTime HIV-1 Negative and Positive Controls must be stored at -10 C or colder. The Abbott RealTime HIV-1 Amplification Reagent Pack and Internal Control vials must be stored at -10 C or colder when not in use. The Abbott msample Preparation SystemRNA (4 X 24 Preps) must be stored at C Maximum shelf-life upon manufacture: Abbott RealTime HIV-1 Amplification Reagent Kit 2G31-90: Abbott RealTime HIV-1 Internal Control 2G31Y: 18 months Thermostable rtth Polymerase Enzyme 56685: Per control date on vendor certificate of analysis HIV-1 Oligonucleotide Reagent 2G31L: 18 months 1 2N2802 is part of 2N2803 Page 2 of 48

3 Activation Reagent 93591: 18 months Abbott RealTime HIV-1 Control Kit 2G31-80: Negative Control 2G31Z: 18 months Low Positive Control 2G31W: 18 months High Positive Control 2G31X: 18 months Abbott RealTime HIV-1 Calibrator Kit 2G31-70: Calibrator A 2G31A: 18 months Calibrator B 2G31B: 18 months Abbott msample Preparation SystemRNA Kit 04J70-24: 18 months Summary of prequalification status for Abbott RealTime HIV-1 (Manual) Initial acceptance Date Outcome Status on PQ list 17 October 2011 listed Dossier assessment 28 September 2011 MR Inspection status 29 September 2011 MR Laboratory evaluation FT MR MR: Meets Requirements, NA: Not Applicable, FT: Fast-tracked The Abbott RealTime HIV-1 (Manual) was accepted for the WHO list of prequalified diagnostics on the basis of data submitted and publicly available information. Background information Abbott Molecular Inc. submitted an application for prequalification of Abbott RealTime HIV-1 (Manual). Based on the established prioritization criteria, Abbott RealTime HIV-1 (Manual) was given priority for prequalification. Product dossier assessment In 2011, Abbott Molecular Inc. submitted a product dossier for Abbott RealTime HIV-1 (Manual) as per the Instructions for compilation of a product dossier (PQDx_018 v1). The information submitted in the product dossier was reviewed in accordance with the Internal report on the screening and assessment of a product dossier (PQDx_009 v2) by WHO staff and external experts (assessors) appointed by WHO. Based on the product dossier screening and assessment findings, a recommendation was made to accept the product dossier for Abbott RealTime HIV-1 (Manual) for prequalification. Page 3 of 48

4 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 An inspection was conducted at the site of manufacture (1300 East Touhy Avenue, Des Plaines, IL, USA) of the Abbott RealTime HIV-1 (Manual) on 29 June-1 July 2011 as described in Information for manufacturers on WHO prequalification inspection procedures for the sites of manufacture of diagnostics (PQDx_014 v1). The inspection found that the manufacturer had a well-established quality management system and manufacturing practices in place that would ensure the manufacture of a product of consistent quality. The manufacturer's responses to the nonconformities noted at the time of the inspection were accepted on 29 September Commitments for prequalification: 1. Risk Management Files will be updated to include risk analysis for end users in resource limited and environmentally challenging regions to which the product is distributed. This will apply to the Abbott RealTime HIV-1 (Manual) product as well as to the related products. 2. Abbott Molecular Inc. has committed to work towards improving communication (e.g. customer feedback mechanisms, tailored training, labeling) for users in resource limited regions where 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 Abbott RealTime HIV-1 (Manual) 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 Abbott RealTime HIV-1 (Manual) 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. Page 4 of 48

5 Labelling 1. Labels 2. Instructions for use Page 5 of 48

6 1.1 Abbott RealTime HIV-1 Calibrator Kit (List No. 2G31-70) Page 6 of 48

7 1.1.1 Label for Abbott RealTime HIV-1 Calibrator A (List No. 2G31A) Page 7 of 48

8 1.1.2 Label for the Abbott RealTime HIV-1 Calibrator B (List No. 2G31B) Page 8 of 48

9 1.2 Abbott RealTime HIV-1 Control Kit (List No. 2G31-80) Page 9 of 48

10 1.2.1 Abbott RealTime HIV-1 High Positive Control (List No. 2G31X) Page 10 of 48

11 1.2.2 Abbott RealTime HIV-1 Low Positive Control (List No. 2G31W) Page 11 of 48

12 1.2.3 Abbott RealTime HIV-1 Negative Control (List No. 2G31Z) Page 12 of 48

13 1.3 Abbott RealTime HIV-1 Amplification Reagent Kit (List No. 2G31-90) Page 13 of 48

14 1.3.1 Abbott RealTime HIV-1 Amplification Reagent Pack (List No. 2G31) Abbott RealTime HIV-1 Internal Control (List No. 2G31Y) Page 14 of 48

15 1.4 Labels for the Abbott msample Preparation System (4 x 24 Preps) (List No. 4J70-24) Page 15 of 48

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18 2. Instructions for use 2.1 Abbott RealTime HIV-1 Page 18 of 48

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27 2.2. Abbott m Sample Preparation System Page 27 of 48

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