Hepatitis B Qualitative PCR, Tissue

The detection of Hepatitis B virus (HBV) performed using a modified version of the FDA-approved Hologic Aptima HBV assay. This in vitro nucleic acid amplification test utilizes real-time Transcription-Mediated Amplification (TMA) technology on the Panther system to detect HBV DNA across genotypes A, B, C, D, E, F, G, and H.

The assay targets two highly conserved regions within the polymerase and surface genes, enhancing its tolerance to potential mutations. It is standardized to the 3rd WHO International Standard for Hepatitis B Virus (NIBSC code: 10/264).

The lower limit of detection (LoD), defined as the lowest viral concentration that yields a positive result in 95% of replicates has not been established for certain specimen types, including tissue biopsies, paraffin-embedded tissues, bone marrow, swabs, or cellular fluids. Results are reported as Not Detected or Positive.

The portion of the assay was developed, and its performance characteristics were determined, by the University of Washington Department of Laboratory Medicine and Pathology. It has not been cleared or approved by the U.S. Food and Drug Administration.

For Blood, see Hepatitis B Quantitative [HBVQNT].

Tissue Biopsy: Pea-sized amount in a sterile tube or universal transport media (UTM).

Paraffin Tissue: DO NOT SEND THE ENTIRE BLOCK and DO NOT SEND SLIDES. Slice 3 to 4 sections that are 5 to 50 microns thick into a sterile tube.

Bone Marrow: 5 mL of blood in an EDTA (lavender top) tube; no heparin aspirate in the syringe.

Swab: In a sterile tube or universal transport media (UTM).

Cellular Fluid: 1 mL in a sterile tube.

Unacceptable Samples: Buffy coat collected with a heparin syringe; paraffin slides.

Tissue Biopsy: 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 (ice pack). Samples may be stored at 2 to 8°C (ice pack) for up to 48 hours post-collection. Samples stored at 2 to 8°C for more than 48 hours will be rejected. Do not freeze and thaw.

Paraffin Tissue: Ship at room temperature.

Bone Marrow: Ship at room temperature within 24 hours of collection.

Swabs: Freeze at -20°C or colder. Ship on dry ice. If a freezer and/or dry ice is not available, ship immediately at 2 to 8°C (ice pack). Samples may be stored at 2 to 8°C (ice pack) for up to 48 hours post-collection. Samples stored at 2 to 8°C for more than 48 hours will be rejected. Do not freeze and thaw.

Cellular Fluid: 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 (ice pack). Samples may be stored at 2 to 8°C (ice pack) for up to 48 hours post-collection. Samples stored at 2 to 8°C for more than 48 hours will be rejected. Do not freeze and thaw.

Outside Laboratory:

Buffy Coat: Separate the buffy coat from bone marrow within 24 hours of collection. Freeze at -20°C or colder.

Tissue/Cellular Fluid/Swab: 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 (ice pack). Samples may be stored at 2 to 8°C (ice pack) for up to 48 hours post-collection. Shipment time must not exceed 48 hours from collection if stored at 2 to 8°C. Samples stored at 2 to 8°C for more than 48 hours will be rejected. Do not freeze and thaw.