Hepatitis C Virus (HCV) Antibody Screen with Reflex to HCV RNA, PCR

Test Code
HCVAB


Alias/See Also
Epic: LAB868


Preferred Specimen

Specimen Type: Serum
Collection Container: Serum gel
Specimen Volume: 3 mL




Minimum Volume

0.5 mL




Other Acceptable Specimens

Collection Container: Red top




Instructions
Centrifuge and separate cells after clot formation and within 4 hours of collection.


Transport Container
Plastic vial


Specimen Stability

Room temperature: 3 days
Refrigerated: 7 days
Frozen: 1 month




Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Unlabeled, mislabeled, wrong tube type, grossly hemolyzed, QNS, exceeds specimen/stability requirements.




Methodology

Chemiluminescent microparticle immunoassay



Setup Schedule

Daily




Report Available

Same day




Limitations

A non-reactive test does not exclude the possibility of exposure to hepatitis C virus.
Results obtained with this methodology cannot be used interchangeably with results from other methodologies.
Reactive anti-HCV does not exclude co-infection with other hepatitis viruses.
Heterophile antibodies, HAMA interfere with the methodology, and may cause false results.
Not intended for use in screening blood, plasma, or tissue donors.
Assay performance characteristics have not been established for newborns, infants, children, immunocompromised or immunosuppressed patients.




Reference Range
Non-reactive


Clinical Significance
HCV is transmitted through transfusion and intravenous drug abuse.  An estimated 3.5 million chronic HCV carriers are in the United States alone.
HCV antibody may not be detectable for up to 6 months following infection, but is usually always detected by late convalescent stage.  Negative results should be evaluated cautiously with respect to clinical findings.  When HCV infection is suspected, detection of HCV RNA by reverse transcriptase polymerase chain reaction provides the most sensitive and specific technique available for the direct detection of HCV in patient serum.



Performing Laboratory

Inova Laboratories

2832 Juniper Street

Fairfax, VA 22031




Last Updated: April 10, 2023
Last Review: N. Wolford, April 10, 2023


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.