INTENDED USE

The Alinity m HIV-1 assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for the detection and quantification of Human Immunodeficiency Virus type 1 (HIV-1) RNA on the automated Alinity m System for confirmation of HIV-1 infection or for monitoring HIV-1 infected individuals. The Alinity m HIV-1 assay is intended for use in the clinical management of HIV-1 infected individuals in conjunction with clinical presentation and other laboratory markers.

The Alinity m HIV-1 assay is intended for use to monitor disease prognosis by measuring baseline plasma HIV-1 RNA levels and to assess response to antiretroviral treatment by measuring changes in plasma HIV-1 RNA levels. Performance for quantitative monitoring is not established with serum specimens.

The Alinity m HIV-1 assay is also intended for use as a supplemental test to confirm HIV-1 infection in individuals who have reactive results with HIV immunoassays. Performance for supplemental use is established with both plasma and serum specimens.

The results from the Alinity m HIV-1 assay must be interpreted within the context of all relevant clinical and laboratory findings.

This device is not intended for use as a first line diagnostic test or for screening donors of blood, blood products, or human cells or tissues, or cellular and tissue-based products (HCT/Ps).

LIMITATIONS OF THE PROCEDURE

• Optimal performance of this test requires appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the package insert.)
• Only human serum (including SST) and plasma (ACD, K2 EDTA, K3 EDTA, and PPT) specimens can be used with the Alinity m HIV-1 assay. The use of other anticoagulants have not been evaluated.
• Debris within plasma and serum specimens (eg, clots, fibrin strands) may interfere with sample processing.
• Performance of the supplemental test to confirm HIV-1 infection in individuals who have reactive results with HIV immunoassays was established for HIV-1 viral load at ≥100 Copies/mL.
• Diluted specimens must be tested within 2 hours after dilution and should not be frozen.
• If the HIV-1 results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
• HIV-1 RNA concentration (ie, number of virus particles present in the samples) may be affected by patient factors (age, presence of symptoms) and/or stage of infection.
• Though rare, mutations within the highly conserved regions of a viral genome detected by Alinity m HIV-1 may affect primers and/or probe binding resulting in the under-quantitation of virus or failure to detect the presence of virus. To ensure assay robustness, the Alinity m HIV-1 assay is designed to target two highly conserved sequences within the HIV-1 genome.
• Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform method correlation studies in their laboratory to evaluate technology differences. Users should follow their own specific policies/procedures.
• The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in the package insert.
• Assay linearity for HIV-1 Group M subtype BF, subtype H and Group N quantification was tested up to 10,000 Copies/mL for subtype BF, 300,000 Copies/mL for subtype H, and 1,000,000 Copies/mL for Group N, respectively.

For in vitro diagnostic use. Rx Only.