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HelpTest Code HCVDX Hepatitis C Virus (HCV) Antibody with Reflex to HCV RNA, PCR, Symptomatic, Serum
Reporting Name
HCV Ab w/Reflex to HCV PCR, SPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Useful For
Diagnosis of recent or chronic hepatitis C virus (HCV) infection in symptomatic patients
This test should not be used as a screening or confirmatory test for hepatitis C in blood or human cells/tissue donors.
This test profile is not useful for detection or diagnosis of acute hepatitis C, since HCV antibodies may not be detectable until after 2 months following exposure and HCV RNA testing is not performed on specimens with negative HCV antibody screening test results.
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
Ordering Guidance
This test is not intended for testing asymptomatic individuals (ie, screening purposes). For testing such patients with or without risk factors for hepatitis C virus (HCV) infection, order HCSRN / Hepatitis C Virus (HCV) Antibody Screen with Reflex to HCV RNA, PCR, Asymptomatic, Serum.
For testing autopsy/cadaver or hemolyzed specimens, order HCCAD / Hepatitis C Virus Antibody Screen for Cadaveric or Hemolyzed Specimens, Asymptomatic, Serum for asymptomatic individuals or HCCDD / Hepatitis C Virus Antibody in Cadaveric or Hemolyzed Specimens, Symptomatic, Serum for symptomatic individuals.
For patients with acute or recent HCV infections (<3 months from time of exposure) or who are repeatedly reactive by screening tests and should be confirmed by a more HCV-specific test, order HCVQN / Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR, Serum.
If testing is desired to distinguish between true positivity and biologic false positivity for HCV antibody, then testing may be done with a second HCV antibody assay approved by the US Food and Drug Administration for diagnosis of HCV infection that is different from the assay used for initial antibody testing (HCCAD / Hepatitis C Virus Antibody Screen for Cadaveric or Hemolyzed Specimens, Asymptomatic, Serum).
Shipping Instructions
If shipment will be delayed for more than 24 hours, freeze serum at -70° C until shipment and transport on dry ice.
Necessary Information
Date of collection is required.
Specimen Required
Patient Preparation: For 24 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Serum gel (red-top tubes are not acceptable)
Submission Container/Tube: Plastic vial
Specimen Volume: 1.3 mL
Collection Instructions:
1. Centrifuge blood collection tube per manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
Specimen Type
Serum SSTSpecimen Minimum Volume
0.9 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum SST | Frozen (preferred) | 84 days | |
| Refrigerated | 6 days |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Interpretation
This assay is not licensed by the US Food and Drug Administration for the screening of blood, plasma, and tissue donors.
For diagnostic purposes, results should always be assessed in conjunction with the patient’s medical history, clinical examination, and other findings.
A reactive anti-HCV result does not exclude co-infection by another hepatitis virus.
False positive results due to non-specific reactivity cannot be ruled out with the Elecsys Anti-HCV II assay. In rare cases, interference due to extremely high titers of antibodies to streptavidin or ruthenium can occur, causing false-reactive anti-HCV results.
Infants born to HCV-infected mothers may have false-reactive HCV antibody test results due to transplacental passage of maternal HCV IgG antibodies. HCV antibody testing is not recommended until at least 18 months of age in these infants.
A single negative hepatitis C virus (HCV) RNA test result together with a reactive anti-HCV screen result with a cutoff index value greater than 20.0 does not rule out the possibility of chronic HCV infection. Repeat testing for HCV RNA in 1 to 2 months is recommended in patient at risk for chronic hepatitis C.
Serum specimens from individuals taking biotin supplements at 20 mg or more per day may have false-negative HCV antibody test results with this assay due to interference of biotin. Such individuals should stop taking these biotin-containing dietary supplements for a minimum 12 hours before blood collection for this test.
Negative anti-HCV test results from immunosuppressed individuals should be interpreted with caution.
Results obtained with the Elecsys Anti-HCV II assay may not be used interchangeably with values obtained with different manufacturers’ assay methods.
Assay performance characteristics have not been established for the following specimen characteristics or specimen types:
-Grossly icteric (total bilirubin level of >66 mg/dL)
-Grossly lipemic (intralipid level of >2000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >1000 mg/dL)
-Biotin >1200 ng/mL
-Presence of particulate matter
-Cadaveric specimens
-Specimen types other than serum
Day(s) Performed
Monday through Saturday
Report Available
Same day/1 to 3 daysTest Classification
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
86803
87522 (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HCVDX | HCV Ab w/Reflex to HCV PCR, S | 40726-2 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| HCVA4 | HCV Ab, S | 40726-2 |
Forms
If not ordering electronically, complete, print, and send 1 of the following:
Testing Algorithm
If hepatitis C virus (HCV) antibody screen is reactive, then HCV RNA by reverse transcription polymerase chain reaction will be performed at an additional charge.
For more information see Hepatitis C: Testing Algorithm for Screening and Diagnosis.
Special Instructions
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HCVQN | HCV RNA Detect/Quant, S | Yes | No |