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Beaumont Laboratory

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

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 72 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): 6 weeks

Specimen Storage in Department Prior to Disposal:

Frozen (-20°C/-4°F or below): 4 weeks

Laboratory

Royal Oak Clinical Molecular Pathology Laboratory.

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.

Epidemiology

The Centers for Disease Control and Prevention (CDC) estimates that in the United States 140,000 to 320,000 persons become infected with HBV each year. New infections result in 8,400 to 19,000 hospital admissions annually and 140 to 320 deaths from fulminant hepatitis.

Transmission

The virus is blood-borne and is transmitted efficiently by exposure to blood. HBV is also commonly transmitted sexually and through perinatal transmission. Infections with HBV in the United States mostly occur in adults who are exposed through sexual or blood contact with a chronically infected person.

CPT Code

87517.

Test Codes

EPIC: LAB6397, SOFT: IHBVG

Last Updated

06/20/2017

Microtainer® and Vacutainer® are registered trademarks of Becton, Dickinson and Company.
UroVysion® is a registered trademark of Abbott Laboratories. ThinPrep® is a registered trademark of Hologic, Incorporated.

This directory currently reflects information only for specimens collected and/or processed at the Farmington Hills, Grosse Pointe, Royal Oak, and Troy campuses.