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Test Code HCCAD Hepatitis C Virus Antibody Screen, Cadaveric or Hemolyzed Specimens, Asymptomatic, Serum

Reporting Name

HCV Ab Cadaver/Hemolyzed Screen, S

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Useful For

Screening cadaveric or hemolyzed serum specimens for hepatitis C virus (HCV) infection in asymptomatic individuals with or without risk factors for HCV infection

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

 

This test is not intended for screening blood, cell, or tissue donors.

 

This test is not intended for testing symptomatic individuals (ie, diagnostic purposes).

 

This test is not useful for ruling out acute HCV infection.

 

This test is not useful for differentiation between resolved and acute or chronic HCV infection.

Method Name

Enzyme Immunoassay (EIA)


Ordering Guidance


For testing hemolyzed specimens from symptomatic patients with or without risk factors for hepatitis C virus (HCV) infection, order HCCDD / Hepatitis C Virus Antibody, Cadaveric or Hemolyzed Specimens, Symptomatic, Serum.



Necessary Information


Date of collection is required.



Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into plastic vial.


Specimen Type

Serum

Specimen Minimum Volume

0.2 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 28 days
  Ambient  7 days
  Refrigerated  7 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Reference Values

Negative

Interpretation

All specimens with signal-to-cutoff ratios of 1.0 or greater will be considered reactive and reflex to the hepatitis C virus (HCV) antibody confirmatory test by line immunoassay (HCVL / Hepatitis C Virus Antibody Confirmation, Serum) at an additional charge. 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 antibody levels below the limit of detection of this assay or lack of reactivity to the HCV antigens used in this assay. Patients with 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).

Day(s) Performed

Monday, Thursday

Report Available

1 to 7 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)

86804 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HCCAD HCV Ab Cadaver/Hemolyzed Screen, S 13955-0

 

Result ID Test Result Name Result LOINC Value
87858 HCV Ab Cadaver/Hemolyzed Screen, S 13955-0

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)

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
HCVL HCV Ab Confirmation, S Yes No

Testing Algorithm

If screen is reactive, then confirmation will be performed at an additional charge.

 

For more information see Hepatitis C: Testing Algorithm for Screening and Diagnosis