Hepatitis C Virus Antibody, Cadaveric or Hemolyzed Specimens, Symptomatic, Serum
Use
This test is used for the diagnosis of hepatitis C virus (HCV) infection in cadaveric or hemolyzed serum specimens from symptomatic patients, with or without risk factors for HCV infection. The presence of HCV antibodies is indicative of past or present infection; however, it does not provide information on the clinical response to antiviral therapy or differentiate between resolved and ongoing infection.
Special Instructions
This test is specifically for symptomatic patients and is not intended for screening asymptomatic individuals or blood, cell, or tissue donors. Positive screening test results should be confirmed with a supplemental test such as the hepatitis C virus antibody confirmation test (HCVL) or nucleic acid testing.
Limitations
The test does not rule out acute HCV infections or differentiate between resolved and acute or chronic hepatitis C infections. HCV antibodies are generally not detectable during the early months following infection. There is a possibility of false-reactive results in antibody screening and a long delay between exposure and detectable antibodies. For grossly hemolyzed (>800 mg/dL hemoglobin), icteric (bilirubin >30 mg/dL), and lipemic (>3000 mg/dL triglyceride) specimens, as well as heat-treated specimens, the performance characteristics have not been established.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ELISA)
Biomarkers
LOINC Codes
- 13955-0
- 13955-0
Result Turnaround Time
1-7 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.5 mL
Minimum Volume
0.2 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions. Aliquot serum into a plastic vial.
Causes for Rejection
Gross hemolysis acceptable, but heavily hemolyzed, icteric, lipemic, or specimens with particulate matter may be rejected.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 7 days |
| Refrigerated | 7 days |
| Frozen | 28 days |