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Test 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.

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.

Method Name

Electrochemiluminescence Immunoassay (ECLIA)

Reporting Name

HCV Ab w/Reflex to HCV PCR, S

Specimen Type

Serum SST

Specimen 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

Reference Values

Negative

For more information see Viral Hepatitis Serologic Profiles

Day(s) Performed

Monday through Saturday

Report Available

Same day/1 to 3 days

Performing 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)

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

NY State Approved

Yes

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:

-Gastroenterology and Hepatology Test Request (T728)

-Infectious Disease Serology Test Request (T916)