Hepatitis B Quantitative

The Hologic Aptima HBV Quant assay is an in vitro nucleic acid amplification test that utilizes real-time Transcription-Mediated Amplification (TMA) technology on the Panther system to quantify HBV DNA from genotypes A, B, C, D, E, F, G, and H. The Aptima HBV Quant assay targets two highly conserved regions in the polymerase and surface genes, ensuring increased tolerance to potential mutations. This assay is standardized to the 3rd WHO International Standard for Hepatitis B Virus (NIBSC code: 10/264).

The lower limit of quantitation is 10 IU/mL (1.00 log IU/mL). The limit of detection, defined as the minimum virus level that yields a positive result in 95% of replicates, is 4.8 IU/mL for plasma and 5.9 IU/mL for serum.

Blood: Collect 3 mL of blood in an EDTA (lavender top) tube.

Also Acceptable: 3 mL of blood in a gold SST, red, or PPT (pearl top) tube.

Unacceptable Samples: Plasma collected in sodium or lithium heparin is not acceptable.

Note: Separate specimens must be submitted when both serology and PCR testing are ordered.

Blood: Separate plasma or serum from whole blood within 24 hours of collection, following the manufacturer’s instructions for the tube used. Freeze at -20°C or colder and ship on dry ice. If a freezer and/or dry ice is not available, ship immediately at 2 to 8°C with an ice pack. Samples may be stored in the primary tube or a secondary tube at 2 to 8°C (with an ice pack) for up to 5 days post-collection. Samples stored at 2 to 8°C for more than 5 days will be rejected. Do not freeze and thaw.

Outside Laboratory: Freeze at -20°C or colder and ship on dry ice. If a freezer and/or dry ice is not available, ship immediately at 2 to 8°C with an ice pack. Samples may be stored in the primary tube or a secondary tube at 2 to 8°C (with an ice pack) for up to 5 days post-collection. Samples stored at 2 to 8°C for more than 5 days will be rejected. Do not freeze and thaw.