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HelpTest Code HCVDX Hepatitis C Virus (HCV) Antibody with Reflex to HCV RNA, PCR, Symptomatic, Serum
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.
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.
Special Instructions
Method Name
Electrochemiluminescence Immunoassay (ECLIA)
Reporting Name
HCV Ab w/Reflex to HCV PCR, SSpecimen 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 |
Clinical Information
Hepatitis C virus (HCV) is recognized as the cause of most cases of posttransfusion hepatitis and is a significant cause of morbidity and mortality worldwide. In the United States, HCV infection is quite common, with an estimated 2.4 million chronically HCV-infected individuals.
Laboratory testing for HCV infection usually begins by screening for the presence of HCV-specific antibodies in serum, using an US Food and Drug Administration-approved screening test. Specimens that are repeatedly reactive by screening tests should be confirmed with HCV tests with higher specificity, such as direct detection of HCV RNA by reverse transcription polymerase chain reaction or HCV-specific antibody confirmatory tests.
HCV antibodies are usually not detectable during the first 2 months following infection, but they are usually detectable by the late convalescent stage (>6 months after onset) of infection. These antibodies do not neutralize the virus and they do not provide immunity against this viral infection.
Current screening serologic tests to detect antibodies to HCV include enzyme immunoassay and chemiluminescence immunoassay.
Despite the value of serologic tests to screen for HCV infection, several limitations of serologic testing exist:
-There may be a long delay (up to 6 months) between exposure to the virus and the development of detectable HCV-specific antibodies in immunocompromised individuals
-False-reactive screening test result can occur
-A reactive screening test result does not distinguish between past (resolved) and present HCV infection
-Serologic tests cannot provide information on clinical response to anti-HCV therapy
Reactive screening test results should be followed by a supplemental or confirmatory test, such as nucleic acid test for HCV RNA or HCV antibody confirmatory test. Nucleic acid tests provide a very sensitive and specific approach for the direct detection of HCV RNA.
For more information see Hepatitis C: Testing Algorithm for Screening and Diagnosis.
Day(s) Performed
Monday through Saturday
Report Available
Same day/1 to 3 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test 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)
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HCVQN | HCV RNA Detect/Quant, S | Yes | No |
Forms
If not ordering electronically, complete, print, and send 1 of the following: