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Test ID: HCSRN Hepatitis C Virus (HCV) Antibody Screen with Reflex to HCV RNA, PCR, Asymptomatic, Serum


Ordering Guidance


This test is not intended for testing symptomatic individuals (ie, diagnostic purposes). For testing such patients with or without risk factors for hepatitis C virus (HCV) infection, order HCVDX / Hepatitis C Virus (HCV) Antibody with Reflex to HCV RNA, PCR, Symptomatic, 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 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 (RT-PCR), Serum.



Shipping Instructions


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



Necessary Information


Date of collection is required.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

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

Screening for hepatitis C in primary care settings in high-risk persons with a current or previous history of illicit injection drug use or a history of receiving a blood transfusion prior to 1992

 

Screening for hepatitis C in primary care settings in non-high-risk persons born from 1945 through 1965

 

Screening at least once in a lifetime for all adults greater or equal to 18 years old, except in settings where the prevalence of HCV infection is less than 0.1%

 

This test is not offered 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 virus (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 HCV antibody screening test results.

Testing Algorithm

If the 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

Chemiluminescence Immunoassay (CIA)

Reporting Name

HCV Ab Scrn 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-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. Decrease in the HCV antibody level in serum may occur following resolution of infection.

 

Current screening serologic tests to detect antibodies to HCV include enzyme immunoassay and chemiluminescence immunoassays. 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

-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 a 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.

Reference Values

Negative

 

See Viral Hepatitis Serologic Profiles

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. Additional testing is recommended to confirm HCV antibody status.

 

Reactive results with S/Co ratios of 8.0 or greater are highly predictive (95% or greater probability) of the true HCV antibody 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 (CDC): Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 2013 May 10;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 9, 2022. Available at www.hcvguidelines.org/contents

Day(s) Performed

Monday through Saturday

Report Available

Same day/1 to 2 days

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

G0472 (if appropriate for government payers)

87522 Hepatitis C, quantification (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HCSRN HCV Ab Scrn w/Reflex to HCV PCR, S 40726-2

 

Result ID Test Result Name Result LOINC Value
HCVA5 HCV Ab Screen, S 40726-2

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 Client Test Request (T728)

-Infectious Disease Serology Test Request (T916)

Mayo Clinic Laboratories | Microbiology and Infectious Disease Catalog Additional Information:

mml-hepatitis