HEPATITIS C VIRUS (HCV) RNA, QUANTITATIVE

Specimen Required
Draw blood in one 7.0 mL 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 plastic vial.
Dedicated specimens are required. Specimens used in other assays will not be tested.

Alternate Specimen
Serum: Red-top

Rejection Criteria
All gel-based plasma separate tubes, Shared specimens, Specimens subjected to repeated freeze-thaw cycles. Specimens that do not meet the storage/handling conditions criteria.

Methodology
This procedure utilizes a real-time Polymerase Chain Reaction (PCR) 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 Log 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 (-20°C): 60 days; Frozen (-70°C): 60 days

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

Performed
Monday-Friday

Turnaround Time3 days
Test CodeHCVQN
CPT-4 Code (s)
87522
LOINC Codes
Hepatitis C RNA, Qualitative   11259-9  
Hepatitis C RNA, Quantitative   49376-7  
Log HCV IU/mL   38180-6  

Warde
Medical
Laboratory