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Test Code HEPC Hepatitis C IgG Antibody

Infectious

Additional Codes

EPIC LAB5378

Clinical Significance

The hepatitis C virus (HCV) is now known to be the causative agent for most, if not all, blood-borne non-A, non-B hepatitis (NANBH). Studies throughout the world indicate that HCV is transmitted through contaminated blood and blood products, through blood transfusions or through other close, personal contacts. The presence of anti-HCV indicates that an individual may have been infected with HCV and may be capable of transmitting HCV infection.

 

Due to the high rate of asymptomatic infections, clinical diagnosis is difficult and diagnostic assays are of major importance. Infection with HCV can lead to acute and chronic hepatitis disease. Approximately 70-85 % of HCV infections progress to chronic disease, although this varies according to patient gender, age, race, and immune status. Chronic HCV infection may lead to cirrhosis and hepatocellular carcinoma. 

 

Source: Roche cobas Elecsys Anti-HCV II method sheet, V 2.0 2024-09 

Methodology

Immunoenzymatic (sandwich) assay (Roche Cobas e801)

Sample Type

Preferred Sample Type
Yellow top - Serum

 

Acceptable Sample Type(s)
Red top - Serum
Light green top - Plasma
Dark green top - Plasma

Centrifuge: Yes

Specimen Minimum Volume

55 uL with insert cup

Specimen Stability

Temperature Time
Ambient (18-25°C) 3 days
Refrigerated (2-8°C) (store) 3 weeks
Frozen (<-20°C) 3 months*

Separate serum or plasma from cells within 2 hours.

*Samples may be frozen/thawed up to 6 times.

Reference Ranges

Initial Testing
Cut-off Index (COI) Result Interpretation Retest Procedure
<0.90 Non-reactive (Negative) HCV antibodies not detected Retesting not required
≥0.90 to < 1.0 Borderline Borderline zone (undetermined) Retest in duplicate
≥1.0 Reactive (Positive) HCV antibodies detected Retesting not required, presumptive evidence of antibodies to HCV. Test will be sent out for confirmation.*

 

Repeat Testing
COI after retest Final Result Interpretation
2 of the 3 results have a COI <1.0 Non-reactive HCV antibodies not detected
2 of the 3 results have a COI ≥1.0 Reactive Presumptive evidence of antibodies to HCV. Test will be sent out for confirmation.*

*Reactive (positive) results will reflex the mayo sendout HCVQN for confirmation. 

Rejection Criteria

Hemolysis Index >1,000
Icterus Index >66
Lipemia Index >2,000, ultracentrifuge

 

Availability

Performed STAT
24/7 Yes

 

Performing Laboratory

MultiCare Yakima Memorial Hospital Laboratory

Lab Department

Chemistry

CPT Code

86803

LOINC

13955-0 HCV Ab IA QI

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