Hepatitis C Virus (HCV) Antibody Screen Prenatal, Serum
Use
This test is useful for screening pregnant women for hepatitis C virus (HCV) infection in primary care settings, irrespective of risk factors. Serologic testing for HCV infection begins by screening for presence of HCV-specific antibodies in serum using FDA-approved tests. However, HCV antibodies may not be detectable until after two months of exposure, and the test is not suitable for diagnosing acute hepatitis C or for donor screening. Reactive results warrant additional tests to differentiate between past resolved and current infection.
Special Instructions
The test should not be used as a screening test for hepatitis C in blood or human cells/tissue donors. It is meant for screening all pregnant women during each pregnancy with positive results reported to local surveillance agencies. Specimens repeatedly reactive should be confirmed with HCV-specific tests. A supplemental or confirmatory test such as a nucleic acid test for HCV RNA is recommended following reactive screening results.
Limitations
There may be a long delay, up to six months, between virus exposure and development of detectable antibodies, especially in immunocompromised individuals. False-positive results can occur, and reactive results do not distinguish between past or current infection. Serologic tests cannot provide information on response to therapy. High biotin levels in patients taking supplements may interfere, causing false-negative results, and specimens need proper handling to prevent issues with results.
FDA ApprovedNew York Approved
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 40726-2
- 40726-2
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1.3 mL
Minimum Volume
0.9 mL
Container
Plastic vial
Collection Instructions
Centrifuge blood collection tube per manufacturer's instructions and aliquot serum into plastic vial.
Patient Preparation
For 24 hours prior to collection, patient should avoid multivitamins or supplements containing biotin.
Storage Instructions
If shipment is delayed over 24 hours, freeze at -70°C and transport on dry ice.
Causes for Rejection
Gross hemolysis, gross lipemia, gross icterus
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 6 days |
| Frozen | 84 days |