Test Details

Mnemonic

AHPR

Ordering Code

3001485

CPT-4 Code(s)

80074, 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

Serum separator tube (SST), Lavender EDTA - Both specimens required

Specimen Preparation

Centrifuge, separate serum from cells and send 4.0 mL serum and 3.0 mL plasma in screw capped plastic vials. Serum should be labeled with AHP label and plasma with HCVFR label.

Alternate Specimen

Red top, lavender EDTA (follow plasma collection guide for PCR)

Minimum Volume

SST: 2.0 mL serum
EDTA: 2.5 mL plasma

Transport Temperature

Serum separator tube (SST): Refrigerated
Plasma EDTA: Frozen

Rejection Criteria

Gross hemolysis, gross lipemia, heparin plasma

Stability

Room temperature: Unacceptable
Refrigerated: 5 days
Frozen (-20°C): Undetermined

Methodology

AHP 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 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 quantitation. A "Not detected" result does not rule out infection.
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Reference Range

Hepatitis A IgM Antibody Negative
Hepatitis B Surface Antigen Negative
Hepatitis B Core IgM Antibody Negative
Hepatitis C Antibody Screen Nonreactive
HCV RNA, Qualitative Not detected
HCV RNA, Quantitative <12 IU/mL
Log HCV IU/mL <1.08 Log IU/mL

See Website: Resource/Interpretation Guide
and Forms/Viral Serology Testing Guide
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Performing Laboratory

Warde Medical Laboratory
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New York DOH Approval Status

Yes
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