INTENDED USE

The Alinity m HBV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate Hepatitis B Virus (HBV) DNA in human plasma or serum. The Alinity m HBV assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the Alinity m HBV assay must be interpreted within the context of all relevant clinical and laboratory findings.

This assay is not intended to be used in screening blood, blood products, or cell, tissue, and cellular and tissue-based products (HCT/Ps), or as a diagnostic test to confirm the presence of HBV infection.

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 tubes and rapid-clot tubes) and plasma (ACD, K2 EDTA, K3 EDTA, and PPT) specimens may be used with the Alinity m HBV assay. The use of other plasma and serum tubes have not been evaluated.
• Diluted specimens must be tested within 2 hours after dilution and should not be frozen.
• Debris within serum and plasma specimens (e.g., clots, fibrin strands) may interfere with sample processing.
• Assay performance for determining the clinical stage of HBV infection has not been established.
• 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.

For in vitro diagnostic use

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