Donor, Hepatitis C Antibody (Anti‑HCV)
Use
This test is intended to be used as a primary screening test for the diagnosis of acute or chronic hepatitis due to Hepatitis C virus (HCV) infection. It is approved by the FDA for screening of donors of blood, blood components and human cells, tissues and tissue‑based products (HCT&P), and is also intended for use to screen organ donors (both heart‑beating and cadaveric). A positive result is indicative of infection with HCV and may be used to disqualify a potential donor. It is not intended for routine clinical diagnostic testing and not for use on cord blood specimens.
Special Instructions
Label tubes with at least two unique patient identifiers. For frozen transport, centrifuge and transfer serum or plasma into a plastic screw‑cap aliquot tube labeled with specimen type and identifiers; these must be processed and labeled at the collection site. If aliquot tubes are submitted, do not send the original collection tube.
Limitations
Not intended for routine clinical diagnostic testing. Not for use on cord blood specimens.
FDA Approved
Methodology
Immunoassay (Other)
Biomarkers
Result Turnaround Time
36 hours
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
2 mL
Minimum Volume
1 mL
Collection Instructions
Serum, or Plasma collected in an EDTA (lavender‑top) tube.
Causes for Rejection
Gross hemolysis; Sample not marked serum/plasma; Specimens other than serum or plasma; Heat‑inactivated specimens; Pooled specimens; Specimens with obvious microbial contamination; Specimens with fungal growth
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 7 days |
| Refrigerated | 14 days |
| Frozen | 9 months |