Hepatitis B DNA PCR Quantitative

Message
Performing Lab: Central Lab


Test Code
4685


Alias/See Also
Sunquest: HBVQT; Hepatitis B DNA real-time PCR, Quantitative (Viral Load)


CPT Codes
87517

Preferred Specimen
Serum Separator FULL (tall gold-top) tube


Minimum Volume
1.5 mL


Other Acceptable Specimens
Red, Red/Gray


Instructions
Collection:
Centrifuge within 6 hours of collection. Send the parent tube to Central Lab, no need to send aliquot.

Processing:
Remove or separate serum within 6 hours of collection.

Shipping:
Decant the serum into a separate “PCR Acceptable” transport vial.
Must use SPECIAL PCR transport vials with screw-caps. To avoid cross-contamination, please handle each patient specimen and decant PCR tube with a separate set of clean gloves.


Transport Container
Send original/parent collection vial


Transport Temperature
Refrigerated


Specimen Stability
Refrigerated: 7 days once serum is separated from cells


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Any plasma or non-serum specimen


Methodology
Real Time Polymerase Chain Reaction (RT-PCR)

Setup Schedule
Monday - Friday (HBV Qt Run at least twice per week)


Report Available
Within 5 days of collection


Limitations
Based on Practice Guidelines recommended by the American Association for the Study of Liver
Disease (AASLD), The HBV PCR Quant test may be ordered (along with Hepatitis Be Ag & Hepatitis BeAb) as an additional reflex test for patients found to be Positive (Reactive) for Hepatitis B surface Antigen (HBsAg). Refer to the separate catalog pages for Hepatitis B surface antigen for clarification on which HBsAg order codes to use. The AASLD guidelines can be accessed on the web at the following address: http://www.aasld.org/practiceguidelines

HBV PCR Quant specimens resulted as Detected are reported to the Department of Health.


Reference Range
Not Detected


Clinical Significance
This HBV Quantitative assay is a Real-Time Polymerase Chain Reaction (RT-PCR) assay for the quantitation of the Hepatitis B virus. It tests over a linear range of 10 – 1,000,000,000 IU/ml (1.00 – 9.0 log IU/ml) and is approved to report detectable levels below 10 IU / ml. This assay is FDA-approved to detect HBV Genotypes A – H. It is intended for use in the conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in serum HBV DNA levels. Based on Practice Guidelines recommended by the American Association for the Study of Liver Disease (AASLD), The HBV PCR Quant test may be ordered (along with Hepatitis Be Ag & Hepatitis BeAb) as an additional reflex test for patients found to be Positive (Reactive) for Hepatitis B surface Antigen (HBsAg). Refer to the separate catalog pages for Hepatitis B surface antigen for clarification on which HBsAg order codes to use. The AASLD guidelines can be accessed on the web at the following address: http://www.aasld.org/practiceguidelines




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.