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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 HCVL
Performed by? Microbiology (Serology)
Sendout? No
Price range $$$$
In House Availability 2 - 14 days TAT
Principle Hepatitis C 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 RNA genome of HCV in clinical specimens to quantitate the HCV viral load. An RNA sequence that is unrelated to the HCV target sequence is introduced into each specimen at the beginning of sample preparation. This unrelated RNA sequence serves as an internal control to demonstrate that the extraction/amplification process has proceeded correctly for each sample. The amount of HCV 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 HCV RNA concentration present in the original sample.

Results range from less than 12 IU/mL (1.08 log IU/mL) to greater than 100 million IU/mL (8.0 log IU/mL).
Interpretation Viral load is used to monitor HCV levels in patients on antiviral therapy and to assess therapeutic efficacy.

This test is not intended to establish the diagnosis of Hepatitis C Virus infection, and should be ordered only for patients with previously documented HCV 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 1.1 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 HCV Product Insert. 1N30, 51-608374/RI. Abbott Molecular Inc., Des Plaines, IL. May 2011.
CPT coding 87522
Last Updated 6/21/2012 12:59:16 PM
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