"Clinical Significance
Hepatitis C Antibody with Reflex to HCV RNA,PCR w/Reflex to Genotype, LiPA - Hepatitis C Virus (HCV) is the major cause of hepatitis. Making positive HCV Ab tests reflex to confirmatory molecular testing is necessary to confirm active HCV infection. Providing a second reflex to perform genotyping on HCV isolates when RNA is detected is also a necessary step before starting therapy. This double reflex will reduce the percentage of antibody-positive patients who lack appropriate confirmatory RNA testing and who do not have genotype testing performed.

Preferred Specimen(s)
2.5 mL serum collected in each of 2 Serum Separator Tubes (SST®)

Alternative Specimen(s)
Plasma collected in each of 2 EDTA (lavender-top) tubes

Minimum Volume
2 mL (x2)

Transport Container
Serum Separator Tube (SST®)

Transport Temperature
Room temperature

Specimen Stability
Room temperature: 72 hours
Refrigerated: 14 days
Frozen: 30 days

Reject Criteria
Gross hemolysis • Grossly lipemic • Red-top tube (no gel) • Heparinized plasma

Includes
If Hepatitis C Antibody is Reactive, then Hepatitis C Viral RNA, Quantitative, Real-Time PCR will be performed at an additional charge (CPT code(s): 87522).
If Hepatitis C Viral RNA, Quantitative, Real-Time PCR is ≥300 IU/mL, then Hepatitis C Viral RNA Genotype, LiPA will be performed at an additional charge (CPT code(s): 87902).

Methodology
Immunoassay (IA)

Reference Range(s)
Hepatitis C Antibody    Non-Reactive
Index    <1.00

Alternative Name(s)
HCV with Reflex,HCV Antibody,Hepatitis C RNA Genotype,HCV RNA Genotype, LIPA