Hepatitis C Virus Antibody
| Label Mnemonic: | HEPC |
| Epic code: | LAB627 |
| Downtime form: | A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery |
Chemistry
6240 RCP
356-3527
6240 RCP
356-3527
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:
This assay may be significantly impacted by high-dose biotin (>5 mg
dose) taken within previous 12 hours. High concentrations of biotin
may lead to falsely decreased results. These concentrations may be
found in patients taking over-the-counter supplements with biotin
content much higher than nutritional requirements for biotin.
Specimens should not be collected until at least 12 hours after the
last dose.
May be ordered separately. If supplemental testing is desired, please contact the laboratory.
The Roche Diagnostics Anti-HCV assay run on a Cobas 8000 analyzer 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.
May be ordered separately. If supplemental testing is desired, please contact the laboratory.
The Roche Diagnostics Anti-HCV assay run on a Cobas 8000 analyzer 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)."
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)."
Methodology:
Electrochemiluminescence Immunoassay (ECLIA)
CPT Code:
86803
See also:
Hepatitis C Virus; Quantitative PCR, Plasma
Hepatitis C Virus; Quantitative PCR, Plasma
See Additional Information:
Biotin Interference with Immunoassays
Biotin Interference with Immunoassays