Name: Hepatitis B DNA, Ultra Quant, PCR
Test Name: Hepatitis B DNA, Ultra Quant, PCR
Health Link Test Code: XHBVD
LIS Test Code: HBVDNA
CPT Code(s): 87517
Methodology: Real-Time PCR
The Roche COBAS Ampliprep/COBAS TaqMan HBV test, version 2, is an in vitro nucleic acid amplification test for the quantitation of hepatitis B virus (HBV) DNA.
Days Performed: Once a week.
In-Lab Turnaround Time: 10 days.
Stat In-Lab Turnaround Time: Not available stat.
Collection Container: Lavender top
Collection Volume: 6 mL
Pediatric Collection Volume: 2 mL
Whole Blood < 24 hours, Plasma 3 days
|Whole Blood:||Not acceptable|
|Plasma:||6 weeks -60 to -80°C|
Sample Analyzed: Plasma
Testing Volume: 3 mL
Pediatric Testing Volume: 1.2 mL
Separate cell-free plasma from whole blood and transfer plasma to a sterile polypropylene tube within 6 hours of collection. Freeze plasma at -60°C to -80°C (preferred) for up to 6 weeks or refrigerate plasma for up to 7 days.
Outreach Specimen Processing:
Transport frozen specimen on dry ice to Laboratory. Transport whole blood at ambient temperature.
Transport specimen to laboratory immediately.
LIMIT: One specimen every 48 hours.
If HBV is detected within the analytical measurement range, two results are reported for each assay: a measured International units/mL and a calculated log10 international units/mL result.
Analytical measurement range of this assay is 20 - 170,000,000 International units (IU)/mL (1.30-8.23 log10 International units (IU)/mL). In patients where HBV is detected but outside of the analytical measurement range (AMR), a result <20 IU/mL or > 170,000,000 IU/mL will be reported. If no HBV is detected, a result of "HBV not detected" will be reported.
Interpretation Type: Expected Results
This is a real-time PCR assay. This test does not genotype the virus.
False negative results may be due to the suppression of viral replication to levels below the detection threshold, to inhibitory substances present in the specimen or to rare mutations within the highly conserved region of the viral genome covered by the primers and/or probe of this method.
Plasma specimens that have a hemoglobin concentration of 500 mg/dL or greater will be canceled due to hemoglobin interfence with this method.
This test is approved by the U.S. Food and Drug Administration.