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Test ID: HCVDX Hepatitis C Virus (HCV) Antibody with Reflex to HCV RNA, PCR, Symptomatic, Serum


Advisory Information


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, Serum for asymptomatic individuals or HCCDD / Hepatitis C Virus Antibody in Cadaveric or Hemolyzed Specimens, Serum for symptomatic individuals.

 

For patients with acute or recent HCV infections (<3 months from time of exposure) or  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, Real-Time Reverse Transcription-PCR (RT-PCR), Serum.



Shipping Instructions


If shipment will be delayed for >24 hours, freeze serum at -70° C until shipment on dry ice.



Necessary Information


Date of collection is required.



Specimen Required


Supplies: Aliquot Tube, 5 mL (T465)

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 2 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube 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 infection in symptomatic patients

 

This test is not offered as a screening or confirmatory test for hepatitis C virus (HCV) for blood, human cells, or tissue donors.

 

This test profile is not useful for detection or diagnosis of acute HCV, since HCV antibodies may not be detectable until after 2 months following exposure and HCV RNA testing is not performed on specimens with negative anti-HCV screening test results.

Testing Algorithm

If hepatitis C virus (HCV) antibody screen is reactive, then HCV RNA by reverse transcription-polymerase chain reaction (RT-PCR) will be performed at an additional charge.

  

See Hepatitis C: Testing Algorithm for Screening and Diagnosis in Special Instructions.

Method Name

Chemiluminescence Immunoassay (CIA)

Reporting Name

HCV Ab w/Reflex to HCV PCR, S

Specimen Type

Serum SST

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 28 days
  Refrigerated  5 days

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 chronic HCV carriers.

 

Laboratory testing for HCV infection usually begins by screening for the presence of HCV antibodies in serum, using an FDA-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-PCR (RT-PCR) 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. Decrease in the HCV antibody level in serum may occur after resolution of infection.

 

Current screening serologic tests to detect antibodies to HCV include enzyme immunoassay (EIA) and chemiluminescence immunoassay (CIA). 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 a detectable HCV antibody

-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.

 

See Hepatitis C: Testing Algorithm for Screening and Diagnosis in Special Instructions.

Reference Values

Negative

See Viral Hepatitis Serologic Profiles in Special Instructions.

Interpretation

Reactive hepatitis C virus (HCV) antibody screening results with signal-to-cutoff (S/Co) ratios of below 8.0 are not predictive of the true HCV antibody status and additional testing is recommended to confirm anti-HCV status.

 

Reactive results with S/Co ratios of 8.0 or greater are highly predictive (95% or greater probability) of the true anti-HCV status, but additional testing is needed to differentiate between past (resolved) and chronic hepatitis C.

 

A negative screening test result does not exclude the possibility of exposure to or infection with HCV. Negative screening test results in individuals with prior exposure to HCV may be due to low antibody levels that are below the limit of detection of this assay or lack of reactivity to the HCV antigens used in this assay. Patients with acute or recent HCV infections (<3 months from time of exposure) may have false-negative HCV antibody results due to the time needed for seroconversion (average of 8 to 9 weeks). Testing for HCV RNA using HCVQN / Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum is recommended for detection of HCV infection in such patients.

Clinical Reference

1. Centers for Disease Control and Prevention: Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 2013;62(18):362-365

2. American Association for the Study of Liver Diseases and Infectious Diseases Society of America: HCV guidance: Recommendations for testing, managing, and treating hepatitis C. Accessed September 29, 2020. Available at www.hcvguidelines.org/contents

Day(s) and Time(s) Performed

Monday through Saturday; Varies

Analytic Time

Same day/1 day

Test Classification

This test has been cleared, approved or is exempt by the U.S. 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 13955-0

 

Result ID Test Result Name Result LOINC Value
HCVA4 HCV Ab, S 13955-0

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 a Gastroenterology and Hepatology Client Test Request (T728) with the specimen.

Mayo Clinic Laboratories | Gastroenterology Catalog Additional Information:

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