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