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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, 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 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: 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

Screening for hepatitis C in primary care settings in high-risk persons with a current or past 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 (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 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

Reference Values

Negative

See Viral Hepatitis Serologic Profiles in Special Instructions.

Day(s) Performed

Monday through Saturday

Report Available

Same day/1 to 2 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 and G0472

87522 (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

NY State Approved

Yes

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HCVQN HCV RNA Detect/Quant, S Yes No

Highlights

This screening test is indicated for testing asymptomatic individuals that may or may not have risk factors for a hepatitis C virus infection.

Note: In accordance with National Coverage Determination guidance, this test is indicated for asymptomatic patients born from 1945 through 1965, those with a history of injection drug use, or a history of receiving blood transfusion prior to 1992.