Hepatitis B Virus (HBV) Real-Time Polymerase Chain Reaction (PCR), Quantitative

CPT Code(s):


Specimen Requirements:

  • Acceptable specimens include whole blood, serum or plasma. Blood should be collected in sterile lavender-top tubes, using EDTA as the anticoagulant, or in serum-separation tubes.
  • Samples must be collected aseptically to minimize hemolysis and bacterial contamination.
  • Whole blood must be centrifuged within 6 hours of collection for 20 minutes at 800 – 1600xg. Plasma or serum may be transported frozen at -80 °C.
  • Transportation of whole blood or plasma must comply with country, federal, state and local regulations for the transport of etiologic agents.
  • The minimum required sample volume is 650 μL of plasma or serum.
Sample Rejection Reasons

  • Clotted or frozen specimens
  • Volume less than 650 μL
  • Whole blood more than one day old that has not been spun

Serum or plasma specimens may be stored at 4 °C for up to 72 hours or at -80 °C for up to 6 weeks. It is recommended that specimens be stored in 800 – 900 μL aliquots in microtubes (such as Sarstedt tubes).

Serum and plasma specimens may be frozen and thawed up to five times without loss of HBV DNA.


This test is intended for use as an aid in the management of patients with chronic HBV infection undergoing antiviral therapy. Several guidelines have recommended the use of real-time PCR methodology for HBV DNA quantitation, primarily due to increased sensitivity and a broader linear range. Measurement of HBV DNA levels at baseline and during treatment aids in assessing response to treatment.

This test is not intended for use as a screening test for the presence of HBV in blood or blood products or as a diagnostic test to confirm the presence of HBV infection.

Linearity and precision of the test has been established with HBV Genotype A only.


5 – 8 business days

Reference Values:

HBV DNA not detected