Test Name: HEPATITIS C ANTIBODY, REFLEX CONFIRMATION
Test Code: 2120931
Alias: Anti-HCV
HCV
Hep C
LAB9394
CPT Code(s): 86803, Reflex 87522  
Preferred Specimen:

2.0 mL serum

*Confirmation tube needed in case of positive screen result
Container: 2-SST (gold)
Minimum Volume:

1.0 mL serum

*If a confirmation tube is not sent, this will not be enough sample for confirmation if it is needed
Collection Instructions: Allow specimen to completely clot (this can take up to 60 minutes). Centrifuge for 15 minutes as soon as the specimen is clotted. If the specimen is collected in an anticoagulant tube, centrifuge and transfer the plasma into a properly labeled transfer tube. Specify specimen type (serum or plasma) on transfer tube.
Transport Temperature: Refrigerated
Stability:

Room temperature:  3 days

Refrigerated:  21 days

Frozen:  3 months
Rejection Criteria:

Hemolysis

Gross bacterial contamination

Cadaveric specimens

Body fluids other than human serum and plasma

Not enough sample for confirmation
Limitations:

1. Immunocompromised patients who have HCV may produce levels of antibody below the sensitivity of this assay and may not be detected as positive.

2. The affinity or avidity differences of anti-human IgG/IgM for anti-HCV have not been determined with this assay. Therefore, there may not be a demonstration of a significant increase in antibody level between acute and convalescent specimens for a patient in the late acute stage of infection when IgM antibodies are decreasing.

3. Assay performance characteristics have not been established for newborns, infants, children, or populations of immunocompromised or immunosuppressed patients.

4. Heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. Patients routinely exposed to animals or to animal serum products can be prone to this interference and anomalous values may be observed.
Additional Information:

The confirmatory test will automatically be ordered if necessary.  Additional CPT codes may apply.

This test is not intended for use in screening blood, plasma or tissue donors.

Current methods for the detection of antibodies to HCV may not detect all infected individuals. A nonreactive test result does not exclude the possibility of exposure to HCV.

Results obtained with this assay may not be used interchangeably with values obtained with different manufacturers' assay methods.
Schedule: Set up: Daily; Results in 24-48 hours
Method: Chemiluminescent Microparticle Immunoassay (CMIA)
Clinical Significance: The presence of anti-HCV indicates that an individual may have been infected with HCV, may harbor infectious HCV, and/or may be capable of transmitting HCV infection. Although the majority of infected individuals may be asymptomatic, HCV infection may develop into chronic hepatitis, cirrhosis, and/or increased risk of hepatocellular carcinoma.
Use: Updated 6/28/24
Reference Ranges:

Negative:  <0.90 COI

Borderline: >0.90- <1.0 COI

Reactive: > 1.00 COI

 

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The CPT codes included in this publication are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are provided here for the convenience of our clients; however, correct coding often varies from one carrier to another, and HealthLab may bill specific carriers using codes other than those shown. Clients who bill for services should verify the code(s) with the applicable payor to confirm that their use is appropriate in each case.
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