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.

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.

Alternate Specimen

HCV Antibody: red top, lavender EDTA (follow Plasma collection guide for PCR), lithium heparin,
sodium heparin.
HCV PCR: Serum: red top.
*PCR for antibody testing cannot be done on shared specimens.
Separate tubes must be clearly labeled for antibody and PCR specimens

Minimum Volume

HCV antibody: 0.5 mL
HCV PCR: 2.5 mL

Transport Temperature

Serum: Refrigerated
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

Stability

HCV Antibody:
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.
more

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
more

Performing Laboratory

Warde Medical Laboratory
more

New York DOH Approval Status

Yes
more