Test Details
Mnemonic
HCVR
Ordering Code
3001440
CPT-4 Code(s)
86803, plus 87522 if reflexed to HCV PCR, at additional cost
Specimen Information
Performance of the HCV assay has not been established with cord blood or neonatal specimens.
Collect
HCV Antibody Screen: Serum Separator Tube (SST)
HCV PCR: Lavender EDTA
*Both specimens required.
HCV PCR: Lavender EDTA
*Both specimens required.
Specimen Preparation
HCV Antibody Screen (Label: HCAB) -
Centrifuge, separate serum from cells and send 1.0 mL serum in a screw capped plastic vial.
HCV PCR Plasma (Label: HCVFR):
Centrifuge, separate plasma from cells within 6 hours of collection. Send 3.0 mL plasma in screw
capped plastic vial.
*PCR and antibody testing cannot be done on shared specimens. Separate tubes must be clearly
labeled for antibody and PCR specimens.
Centrifuge, separate serum from cells and send 1.0 mL serum in a screw capped plastic vial.
HCV PCR Plasma (Label: HCVFR):
Centrifuge, separate plasma from cells within 6 hours of collection. Send 3.0 mL plasma in screw
capped plastic vial.
*PCR and antibody testing cannot be done on shared specimens. Separate tubes must be clearly
labeled for antibody and PCR specimens.
Alternate Specimen
Red top, lavender EDTA plasma, lithium heparin, sodium heparin may be substituted for the serum specimen.
Minimum Volume
HCV antibody: 0.5 mL
HCV PCR: 2.5 mL
HCV PCR: 2.5 mL
Transport Temperature
Serum: Refrigerated
Plasma: Frozen
Plasma: Frozen
Rejection Criteria
HCV Antibody: gross hemolysis, gross lipemia
HCV PCR: gross hemolysis, gross lipemia, heparin plasma, gel-based plasma separation tubes,
specimens subjected to repeat freeze thaw cycles, shared specimens
HCV PCR: gross hemolysis, gross lipemia, heparin plasma, gel-based plasma separation tubes,
specimens subjected to repeat freeze thaw cycles, shared specimens
Stability
HCV Antibody:
Room temperature: Undetermined
Refrigerated: 7 days
Frozen: Undetermined
HCV PCR:
Room temperature: Unacceptable
Refrigerated: 3 days
Frozen: 60 days
Room temperature: Undetermined
Refrigerated: 7 days
Frozen: Undetermined
HCV PCR:
Room temperature: Unacceptable
Refrigerated: 3 days
Frozen: 60 days
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.
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.
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
HCV RNA, Qualitative: Not detected
HCV RNA, Quantitative: <12 IU/mL
Log HCV IU/mL: <1.08 Log IU/mL
Performing Laboratory
Warde Medical Laboratory
New York DOH Approval Status
Yes