Florida Bureau of Public Health laboratories
Hepatitis C Antibody Screen (IgG + IgM)
The hepatitis C antibody screening (HCVAb) test provides qualitative and quantitative results for hepatitis C utilizing a chemiluminescent microparticle immunoassay (CMIA) testing method.
Analyte(s)
Hepatitis C Antibody (IgG + IgM)
Test Code
0330
Testing Location
Testing Department
Serology
Pre-approval Required?
None
Required Forms
BPHL Test Requisition, DH1847
(not needed if orders are placed via electronic order)
Supply Ordering
Supplies may be requested from your servicing laboratory. Supplies ordered from BPHL should only be used for specimen sent to the BPHL for testing.
Turn Around time
4 business days after receipt at the laboratory
Minimum Volume
At least 2 mL serum
Collection Media
“Tiger” or “yellow” top SST tube
Specimen Sources
Serum
Specimen Labeling
Specimen must be labeled with at least two unique patient identifiers, e.g., name and DOB, and the date of collection.
Information on the specimen must match the requisition and/or test order.
Special SPecimen Preparation
Centrifuge the SST within 8 hours of collection.
Storage Conditions
Specimens may be stored for up to 7 days after collection at 2-8° C.
If testing will be delayed more than 7 days after collection, remove serum from the clot, red blood cells, or separator gel and store at -20° C or colder. Avoid more than 3 freeze/thaw cycles.
Packaging and Shipping
Ship in a cooler with ice packs at 2-8° C to be received at the laboratory no more than 7 days from the collection date.
Specimens stored frozen should be shipped frozen to avoid additional freeze/thaw cycles.
unsatisfactory specimen
1) Incorrect source or incorrect collection device was used
2) Specimen was not labeled with 2 unique patient identifiers
3) Information on specimen does not match requisition/test order
4) Grossly hemolyzed
5) Leaked in transit
7) No specimen received with test order
9) Specimen not centrifuged
10) Quantity not sufficient (QNS)
11) Specimens that exceed the storage limitations listed above.
12) Specimens received at 2-8° C and greater than 7 days after collection will be cancelled.
Interferences and Limitations
1) For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute and chronic infection.
2) Current methods for the detection of antibodies to HCV may not detect all infected individuals. A non-reactive test result does not exclude the possibility of exposure to HCV.
3) Immunocompromised patients who have HCV may produce levels of antibody below the sensitivity of this assay and may not be detected as positive.
4) Results obtained with this assay may not be used interchangeably with values obtained with different manufacturers’ assay methods.
5) Assay performance characteristics have not been established for newborns, infants, children or populations of immunocompromised or immunosuppressed patients.
6) Patients routinely exposed to animals or to animal serum products can be prone to interference and anomalous values may be observed. Additional information may be required for diagnosis.
7) A reactive anti-HCV result does not exclude co-infection by another hepatitis virus.
Reference Range
Nonreactive
Result Indicator
Reactive
Equivocal
Nonreactive
Reference lab
None
Reflex testing
Test 0390 HCV RNA NAAT if reactive or equivocal
Additional Information
Reactive: Presumptive evidence of antibodies to HCV; follow CDC recommendations for supplemental testing
Equivocal: Antibodies to HCV may or may not be present; follow CDC recommendations for supplemental testing
Nonreactive: Antibodies to HCV not detected; does not exclude the possibility of exposure to HCV