Hepatitis C Virus Antibody
| Order Code: | HEPC |
| Order Form: | Laboratory Requisition |
Specimen:
Plasma
Collection Medium:
 |
| Plasma Separator Tube |
Alternate
Collection Media:
Call laboratory for additional acceptable specimen collection containers.
Minimum:
3 mL whole blood from light green top tube or TWO microtainers for
pediatric patients.
Rejection Criteria:
Grossly hemolyzed specimens are not acceptable.
Testing
Schedule:
24 hrs/day, 7 days a week, including holidays.
Analytic Time:
1 hour (upon receipt in laboratory)
Reference Range:
Non-reactive
Comments:
May be ordered separately.
The Roche Diagnostics Anti-HCV assay run on Modular E analyzers is used for the majority of samples. The Abbott Architect Hepatitis Anti-HCV assay is used as a backup to the Roche assay for two scenarios: (1) samples that are too hemolyzed for the Roche assay but can be run without interference on the Abbott assay and (2) specimens that return grayzone (equivocal) results on the Roche assay.
The Roche Diagnostics Anti-HCV assay run on Modular E analyzers is used for the majority of samples. The Abbott Architect Hepatitis Anti-HCV assay is used as a backup to the Roche assay for two scenarios: (1) samples that are too hemolyzed for the Roche assay but can be run without interference on the Abbott assay and (2) 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 nonreactive test result does not exclude the possibility of exposure to HCV.
Nonreactive 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 reactive anti-HCV result does not exclude co-infection by another hepatitis virus.
Hemolysis: No significant interference up to an H index of 100 (approximate hemoglobin concentration: 100 mg/dL).
Lipemia: No significant interference up to an L index of 2100 (approximate triglycerides concentration: 4200 mg/dL). Note there is poor correlation between turbidity and triglyceride concentration.
Icterus: No significant interference up to an I index of 50 (approximate conjugated and unconjugated bilirubin concentration: 50 mg/dL).
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.
Nonreactive 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 reactive anti-HCV result does not exclude co-infection by another hepatitis virus.
Hemolysis: No significant interference up to an H index of 100 (approximate hemoglobin concentration: 100 mg/dL).
Lipemia: No significant interference up to an L index of 2100 (approximate triglycerides concentration: 4200 mg/dL). Note there is poor correlation between turbidity and triglyceride concentration.
Icterus: No significant interference up to an I index of 50 (approximate conjugated and unconjugated bilirubin concentration: 50 mg/dL).
Methodology:
Chemiluminescent Microparticle Immunoassay (CMIA)
Sample
Processing:
Centrifuge at 3000 RPM for 10 minutes.
Aliquot plasma into labeled container and cap.
Label transport tube with two patient identifiers, date and time of collection.
Aliquot plasma into labeled container and cap.
Label transport tube with two patient identifiers, date and time of collection.
Sample
Storage:
Refrigerate.
Transport
Instructions:
Place requisition into outside pocket of bag.
Place specimen into zip-lock type bag, seal bag.
Transport in cooler with refrigerated coolant packs.
Place specimen into zip-lock type bag, seal bag.
Transport in cooler with refrigerated coolant packs.
CPT Code:
86803
See also:
Hepatitis C Virus RNA by PCR, Plasma
Hepatitis C Virus RNA by PCR, Plasma