Test Details

Mnemonic

HBVQN

Ordering Code

3041500

CPT-4 Code(s)

87517

Specimen Information

Collect

Lavender EDTA

Specimen Preparation

Centrifuge and separate plasma from cells within 6 hours of collection. Send 3.0 mL plasma in a screw capped plastic vial. Dedicated specimens are required. Specimens used in other assays will not be tested.

Minimum Volume

2.5 mL

Transport Temperature

Refrigerated

Rejection Criteria

Serum, all gel-based plasma separation tubes, shared specimens, specimens subjected to repeated freeze-thaw cycles, specimens that do not meet the storage/handling conditions criteria above

Stability

Room temperature: Unacceptable
Refrigerated: 3 days
Frozen (-20°C): 60 days
Frozen (-70°C): 60 days

Methodology

This procedure utilizes a real-time Polymerase Chain Reaction (PCR) procedure from Abbott Molecular. The amplification target is a conserved region in the terminal third of the hepatitis B surface antigen gene. The lower limit of quantitation is 10 IU/mL (1.00 Log IU/mL) and the upper limit of quantitation is 1 billion IU/mL (9.00 Log IU/mL).
The qualitative limit of detection is 10 IU/mL (1.00 Log IU/mL). Specimens reported as "DETECTED" but <10 IU/mL contain detectable levels of hepatitis B DNA but the viral load is below the limit of quantitation. A "Not detected" result does not rule out infection.
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Reference Range

Hepatitis B DNA: Not detected
Hepatitis B DNA, Quantitative: <10 IU/mL
LOG HBV IU/mL: <1.00
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Performing Laboratory

Warde Medical Laboratory
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