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Lab Manual for UCSF Clinical Laboratories

Lab Manual for SFGH

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Item Value
Approval req'd? Micro
Available Stat? No
Test code HBVP
Performed by? Microbiology (Serology)
Sendout? No
Price range $$$$
In House Availability 2 - 14 days TAT
Principle Hepatitis B viral nucleic acid is measured by a Real Time PCR Assay.

This assay uses a reverse transcriptase real-time PCR method to generate amplified product from the DNA genome of HBV in clinical specimens to quantitate the HBV viral load. A DNA sequence that is unrelated to the HBV target sequence is introduced into each specimen at the beginning of sample preparation. This unrelated DNA sequence serves as an internal control to demonstrate that the extraction/amplification process has proceeded correctly for each sample. The amount of HBV target sequence that is present at each amplification cycle is measured through the use of fluorescent-labeled oligonucleotide probes. The probes do not generate a signal unless they are specifically bound to the amplified product. The amplification cycle at which fluorescent signal is detected is proportional to the IU/mL of HBV DNA concentration present in the original sample.

Results range from less than 10 IU/mL (1.0 log IU/mL) to greater than 1billion IU/mL (9.0 log IU/mL).
Interpretation Viral load is used to monitor HBV levels in patients on antiviral therapy and to assess therapeutic efficacy.

This test is not intended to establish the diagnosis of Hepatitis B Virus infection, and should be ordered only for patients with previously documented HBV infection. False-positive low viral load results may occur in uninfected patients.
Container type PPT-EDTA (white/pearl top) tube
Amount to Collect Two (2) dedicated , 5 mL PPT-EDTA tubes
Sample type Blood
Preferred volume 5 mL plasma
Min. Volume 1.0 mL
Normal range Not Detected
Stability Specimen must be received in Clinical Lab within 4 hours from draw. Plasma is immediately separated and frozen by Clinical Laboratory Staff. Frozen plasma is stable at -70°C for one month.
Turn around times 2 - 14 days
References 1. Abbott RealTime HBV Product Insert. 2N40, 51-608234/R2. Abbott Molecular Inc., Des Plaines, IL. February 2011.
CPT coding 87517
Last Updated 9/15/2012 10:02:44 AM
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