Hepatitis C Virus Antibody
| Label Mnemonic: | HEPC |
| Epic code: | LAB627 |
| Order form: | Laboratory Requisition |
| Supply order: | Supply Order Form |
| Billing: | Billing Policies |
| CPT code: | 86803 |
Specimen(s):
Plasma
Collection Medium:
 |
| Plasma Separator Tube 4.5 mL |
Alternate Collection Media:
Call laboratory for additional acceptable specimen collection containers.
Minimum:
3 mL whole blood from light green top tube or TWO Microtainer® devices for pediatric patients.
Rejection Criteria:
Grossly hemolyzed specimens are not acceptable.
Testing Schedule:
24 hrs/day, 7 days a week, including holidays.
Turn Around Time:
1 hour (upon receipt in laboratory)
Reference Range:
Negative
Comments:
May be ordered separately.
The Roche Diagnostics Anti-HCV assay run on a Cobas 8000 analyzer is used for the majority of samples. The Abbott Architect Hepatitis Anti- HCV assay is used as a backup to the Roche assay for specimens that return grayzone (equivocal) results on the Roche assay.
The Roche Diagnostics Anti-HCV assay run on a Cobas 8000 analyzer is used for the majority of samples. The Abbott Architect Hepatitis Anti- HCV assay is used as a backup to the Roche assay for specimens that return grayzone (equivocal) results on the Roche assay.
Test Limitations:
For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute and chronic infection.
Current methods for the detection of antibodies to HCV may not detect all infected individuals. A negative test result does not exclude the possibility of exposure to HCV.
Negative test results in individuals with prior exposure to HCV may be due to antibody levels being below the detection limit of this assay or to lack of antibody reactivity to the recombinant antigens used in this assay.
Immunocompromised patients who have HCV may produce levels of antibody below the sensitivity of this assay and may not be detected as positive.
Assay performance characteristics have not been established for newborns, infants, children, or populations of immunocompromised or immunosuppressed patients.
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 may be required for diagnosis.
A negative anti-HCV result does not exclude co-infection by another hepatitis virus.
Hemolysis: No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1 g/dL).
Lipemia: No significant interference up to an L index of 2000 (approximate triglycerides concentration: 4000 mg/dL). Note there is poor correlation between turbidity and triglyceride concentration.
Icterus: No significant interference up to an I index of 66 (approximate conjugated and unconjugated bilirubin concentration: 66 mg/dL).
Biotin: No significant interference up to 1200 ng/mL of biotin.
Current methods for the detection of antibodies to HCV may not detect all infected individuals. A negative test result does not exclude the possibility of exposure to HCV.
Negative test results in individuals with prior exposure to HCV may be due to antibody levels being below the detection limit of this assay or to lack of antibody reactivity to the recombinant antigens used in this assay.
Immunocompromised patients who have HCV may produce levels of antibody below the sensitivity of this assay and may not be detected as positive.
Assay performance characteristics have not been established for newborns, infants, children, or populations of immunocompromised or immunosuppressed patients.
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 may be required for diagnosis.
A negative anti-HCV result does not exclude co-infection by another hepatitis virus.
Hemolysis: No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 1 g/dL).
Lipemia: No significant interference up to an L index of 2000 (approximate triglycerides concentration: 4000 mg/dL). Note there is poor correlation between turbidity and triglyceride concentration.
Icterus: No significant interference up to an I index of 66 (approximate conjugated and unconjugated bilirubin concentration: 66 mg/dL).
Biotin: No significant interference up to 1200 ng/mL of biotin.
Methodology:
Electrochemiluminescence Immunoassay (ECLIA)
Assay updated with increased tolerance to biotin on 5/14/2024.
Assay updated with increased tolerance to biotin on 5/14/2024.
Sample Processing:
Centrifuge at a speed and time necessary to get barrier separation of plasma/serum and cells within 1 hour of collection. Send specimen in original tube. Do Not transfer to another tube.
Each sample must be labeled with at least TWO full patient identifiers (First/Last Name & DOB are sufficient for non-UIHC affiliated clients) to avoid sample rejection/delays.
Each sample must be labeled with at least TWO full patient identifiers (First/Last Name & DOB are sufficient for non-UIHC affiliated clients) to avoid sample rejection/delays.
Sample Storage:
Refrigerate.
All sample storage requirements are intended for delivery to UIHC within 24 hours of collection for testing. If samples won't arrive in this time period, please call the UIHC Core Lab for alternative storage/shipping instructions (319-356-3527).
All sample storage requirements are intended for delivery to UIHC within 24 hours of collection for testing. If samples won't arrive in this time period, please call the UIHC Core Lab for alternative storage/shipping instructions (319-356-3527).
Transport Instructions:
Place labeled specimen into zip-lock type biohazard bag; seal bag.
Place completed requisition into outside pocket of bag.
Transport in cooler with refrigerated coolant packs.
Place completed requisition into outside pocket of bag.
Transport in cooler with refrigerated coolant packs.
See also:
Hepatitis C Virus; Quantitative PCR, Plasma
Hepatitis C Virus; Quantitative PCR, Plasma