HEPATITIS C VIRUS SUPPLEMENTAL PCR, QUANTITATIVE

Components
This procedure should only be used for evaluating patients with REACTIVE HCV antibody results.

Specimen Required
Draw blood in 1 lavender EDTA tube. Centrifuge and separate plasma from cells within 6 hours of collection. Send 3.0 mL plasma (2.5 mL minimum) frozen in a screw-capped vial. Dedicated specimens are required. Specimens used in other assays will not be tested.

Alternate Specimen
Serum: Red-top

Rejection Criteria
Heparinized specimens, shared specimens, specimens subjected to repeated freeze/thaw

Methodology
This procedure is used to distinguish current active HCV infection. Up to 25% of HCV-infected individuals will clear the infection without antiviral intervention. These individuals will be Reactive in the HCV antibody test and Not Detected in the Qualitative HCV PCR test. This profile will persist for years afer clearing the infection. Patients who have undergone successful antiviral treatment (sustained responders) will have a similar HCV profile,. The presence of HCV RNA indicates active HCV replication.
The HCV RNA PCR procedure utilizes a real-time polymerase chain reaction test from Abbott Molecular. The amplification target is a conserved region of the HCV genome. The lower limit of quantitation is 12 IU/mL (1.08 Log IU/mL) and the upper limit of quantitation is 100 million IU/mL (8.00 Log IU/mL).
The qualitative limit of detection is 12 IU/mL (1.08 IU/mL).
Specimens reported as "DETECTED" but <12 IU/mL contain detectable levels of Hepatitis C RNA but the viral load is below the limit of quantitation. A "Not detected" result does not rule out infection.

Stability
Room Temperature: Unacceptable; Refrigerated: 3 days; Frozen: 60 days

Reference Range
HCV RNA, Qualitative:   Not detected  
HCV RNA, Quantitative:   <12 IU/mL  
Log HCV IU/mL:   <1.08 Log IU/mL  

Performed
Monday-Friday

Turnaround Time3 days
Test CodeHCVSQ
CPT-4 Code (s)
87522
LOINC Codes
Hepatitis C Virus RNA Qualitative:   11259-9  
Hepatitis C Virus RNA, Quantitative:   49376-7  
Log Hepatitis C Virus RNA:   38180-6  

Warde
Medical
Laboratory