Details

HBV DNA Quantitation By PCR

HBV Quant, Hepatitis B Virus DNA, Quantitative by PCR , EPIC: LAB6397, SOFT: IHBVG

Specimen Collection Criteria

Collect: Plasma OR Serum.

  • Plasma: One Lavender-top EDTA tube.
  • Serum: One Gold-top SST tube.
  • Minimum volume and pediatric minimum (single test with no repeat): 1.1 mL serum or plasma.
  • Separate samples must be submitted when multiple tests are ordered.

Physician Office/Drawsite Specimen Preparation

Centrifuge to separate serum or plasma from cells within 24 hours of collection. Transfer serum or plasma to a plastic transport tube and refrigerate (2-8°C or 36-46°F). A centrifuged SST tube is also acceptable at refrigeration temperature. Specimens should be shipped on ice packs or dry ice via courier for overnight delivery.

Preparation for Courier Transport

Transport: Serum or plasma, or centrifuged SST tube, refrigerated (2-8°C or 36-46°F).

Rejection Criteria

  • Specimens not centrifuged with the serum or plasma separated within 24 hours of collection.
  • Unlabeled tubes.
  • Specimens collected in Green-top Heparin, White-top PPT, or Yellow-top ACD tubes.
  • Samples exposed to repeated freeze/thaw cycles.

Storage

Ambient: 6 hours (on cells)
Plasma or serum removed from cells within 6 hours can be refrigerated and stored as follows:
Refrigerated (4oC): up to 3 days
Frozen (-20oC): up to 4 months

Performed

At least once per week.
Results available in 7–10 days.

Reference Range

HBV DNA not detected. The limit of detection is 12.5 IU/mL.
The reportable range is 20 - 170,000,000 IU/mL.
Results exceeding 170,000,000 IU/mL will not be diluted, and will be reported as greater than 170,000,000 IU/mL.

Test Methodology

Quantitative real-time polymerase chain reaction (qPCR)-Roche COBAS® Ampliprep/COBAS® TaqMan® HBV Test, v2.0 (FDA Approved).

Clinical Utility

  • The test is intended for use as an aid in the management of patients with chronic HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from this test must be interpreted within the context of all relevant clinical and laboratory findings. This test is not intended for use as a screening test for blood or blood products for the presence of HBV or as a diagnostic test to confirm the presence of HBV infection.
  • The lower limit of reporting in this assay is less than 20 IU/mL. A result reported as less than 20 IU/mL does not rule out the presence of HBV DNA concentrations below the level of detection of the assay. Improper specimen handling may cause HBV DNA degradation, leading to spuriously lowered viral load values.
  • This test is not intended for use as a screening test for blood or blood products for the presence of HBV or as a diagnostic test to confirm the presence of HBV infection.
  • The lower limit of detection for this assay is 12.5 IU/mL. When HBV DNA is detected, the corresponding HBV DNA viral load will be reported.

CPT Code

87517

Test Codes

EPIC: LAB6397, SOFT: IHBVG

Last Updated

7/11/2019