CPT Code(s):
87517
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.
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.
Reported:
5 – 8 business days
Reference Values:
HBV DNA not detected