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

Performed: 
Weekly
Reported: 
5 - 8 business days
Use: 
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.
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.
Reference Values: 
HBV DNA not detected
CPT Code (s): 
87517
Notes: 

UFHPL Test #: 10085

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