HEPATITIS B VIRUS DNA, QUANTITATIVE

Specimen Required
Draw blood in one 7.0 lavender EDTA tube. Centrifuge and separate plasma from cells within 6 hours of collection. Send 3.0 mL plasma (2.5 mL minimum) refrigerated in a screw-capped plastic vial.
Dedicated specimens are required. Specimens used in other assays will not be tested.

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.

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.

Stability
Room Temperature: Unacceptable; Refrigerated: 3 days; Frozen: (-20°C): 60 days; Frozen (-70°C): 60 days

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

Performed
varies/2x a week

Turnaround Time2-5 days
Test CodeHBVQN
CPT-4 Code (s)
87517
LOINC Codes
Hepatitis B DNA, Qualitative   29610-3  
Hepatitis B DNA, Quantitative   42595-9  
Log HBV   48398-2  

Warde
Medical
Laboratory