Test Details



Ordering Code


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.


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


HCV Antibody:
Room temperature: Undetermined
Refrigerated: 7 days
Frozen: Undetermined

Room temperature: Unacceptable
Refrigerated: 3 days
Frozen: 60 days


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.

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

Performing Laboratory

Warde Medical Laboratory

New York DOH Approval Status