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Hepatitis B Virus DNA Real-Time PCR (138-0476)
Test Mnemonic:

HBV PCR

Specimen Requirements:
Test Included:

Patient has chronic Hepatitis B virus infection and it is being treated. This is not a test to use to diagnose Hepatitis.

Collection:

One pearl color  (PPT) top  or gold (SST) Vacutainer; collect one tube for this test and do not combine with other test orders.

Container:

PPT or SST

Minimum Volume:

4 ml

Storage/Transport:

Store and transport frozen

Specimen Preparation:

Within six hours of collection, centrifuge blood sample at 1,000 x g for 15 minutes. After centrifugation, remove plasma or serum from cells into a screw-cap polypropylene transport tube. Label tube as serum or plasma.

Stability:

Separation must occur within 6 hours of collection, store frozen for up to  one month.

Causes for Rejection:

Incomplete and/or incorrect sample identification, insufficient sample volume, incorrect blood collection tube (Vacutainer), gross hemolysis, clots, prolonged time to processing

Reference Range:

Interpretation of Results:

Not detected: HBV not detected

<10 IU/mL: HBV detected but <10 IU/mL

10-109IU/mL: Quantity of virus detected will be reported

>109 IU/mL: Viral load above the upper limit of quantification.

Turnaround Time:

3-10 days

Methodology:

 Real time PCR

Performed:

Molecular Diagnostics Laboratory

Synonyms:

HBV Virus Load; HBV Quantitative; Hepatitis B Virus, Quantitiative test

Clinical Indication:

Quantification of HBV DNA

Patient Preparation :

Routine venipuncture

CPT 4 Code:

87517

Note:

Submit one PPT tube for each molecular assay requested due to volume needs for testing.

The assay uses the FDA approved Abbott RealTime HBV kit and m2000 system .

A "not detected" result does not rule out the presence of HBV in the patient's specimen or that HBV DNA concentrations may be below the level of quantification.

When ordering tests for which Medicare or Medicaid reimbursement will be sought, physicians should only order tests that are medically necessary for the diagnosis or treatment of the patient. Components of the organ or disease panels may be ordered individually. The diagnostic information must substantiate all tests ordered and must be in the form of an ICD-10 code or its verbal equivalent.
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