INTENDED USE

The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals. The assay is intended for use as an aid in the diagnosis of active HCV infection in individuals with antibody evidence of HCV infection, and to aid in the management of patients with known active HCV infection, including Sustained Virologic Response (SVR) determination.

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

The Alinity m HCV assay is not intended to be used in screening blood, plasma, serum, tissue or tissue donors for HCV.

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).
• Human serum (including serum separator and rapid-clot tubes) and plasma (ACD, K2 EDTA, K3 EDTA, and PPT) specimens may be used with the Alinity m HCV assay. The use of other plasma and serum tubes has not been evaluated.
• Debris within serum and plasma specimens (eg, clots, fibrin strands) may interfere with sample processing.
• 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 this package insert.
• Though rare, mutations within the highly conserved regions of a viral genome covered by the Alinity m HCV may affect primer and/or probe binding resulting in the under‐quantitation of virus or failure to detect the presence of virus. The Alinity m HCV assay mitigates this risk by utilizing two unique probes in a highly conserved region of the HCV genome.
• Assay performance characteristics have been established for individuals treated with certain direct-acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other DAA combination therapies are used.

For in vitro diagnostic use

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