HEPATITIS C ANTIBODY, DIAGNOSTIC, with Reflex to PCR

Specimen Required
Two specimens required. Draw blood in a SST and a 7.0 mL lavender EDTA. Centrifuge, separate, and send 1.0 mL serum (0.5 mL minimum) refrigerated, and 3.0 mL plasma (2.5 mL minimum) frozen in a screw-capped plastic vials. Serum should be labeled with HCAB label, and plasma with HCVFR label.

Alternate Specimen
Serum for a red-top or EDTA plasma may be substituted for the serum specimen.

Rejection Criteria
Gross hemolysis, gross lipemia, heparinized plasma, shared specimens, specimens subjected to repeated freeze/thaw

Methodology
HCV Antibody Screen Methodology: Chemiluminescence
HCV RNA, PCR Methodology: Reactive specimens are tested for HCV RNA using 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 quantitative 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 quantitation. A "Not detected" result does not rule out infection.

Stability
Serum: Room Temperature: Unacceptable; Refrigerated: 5 days; Frozen (-20°C): 14 days
Plasma: Room Temperature: Unacceptable; Refrigerated: 3 days; Frozen (-20°C): 60 days; Frozen (-70°C): 60 days

Reference Range
HCV Antibody Screen:   Nonreactive  
HCV RNA, Qualitative:   Not detected  
HCV RNA, Quantitative:   <12 IU/mL  
Log HCV IU/mL:   <1:08 Log IU/mL  

Performed
HCV Antibody: Sunday-Friday
HCV RNA PCR: Monday-Friday

Turnaround Time5 days
Test CodeHCVR
CPT-4 Code (s)
86803 (plus 87522 if reflexed to HCV PCR, at an additional charge)
LOINC Codes
Hepatitis C Antibody   13955-0  
Hepatitis C Virus RNA Qualitative   11259-9  
Hepatitis C Virus RNA, Quantitative   49376-7  
Log Hepatitis C Virus RNA   38180-6  
HCV Interpretation   Not available  

Warde
Medical
Laboratory