Test Catalog

Test ID: HCCAD    
Hepatitis C Virus Antibody Screen for Cadaveric or Hemolyzed Specimens, Asymptomatic, Serum

Useful For Suggests clinical disorders or settings where the test may be helpful

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.

Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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


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

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Hepatitis C virus (HCV) is recognized as the cause of most cases of post-transfusion 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.


HCV antibodies are usually not detectable during the early months following infection, but they are almost always detectable by the late convalescent stage (>6 months after onset of acute infection). These antibodies do not neutralize the virus, and they do not provide immunity against this viral infection. Loss of HCV antibodies may occur many years following resolution of infection.


Despite the value of serologic tests to screen for HCV infection, several limitations of serologic testing are known:

-There may be a long delay (up to 6 months) between exposure to the virus and the development of detectable antibodies.

-False-reactive screening test results 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 antiviral therapy.


Positive screening serologic test results should be followed by a confirmatory or supplemental test, such as line immunoassay (HCVL / Hepatitis C Virus Antibody Confirmation, Serum) for HCV antibodies or a nucleic acid test for HCV RNA. Although nucleic acid tests provide a very sensitive and specific approach to directly detect HCV RNA in a patient's blood, they are not suitable for use in testing cadaveric blood specimens due to interference of heme with the nucleic acid amplification processes.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.


Interpretation Provides information to assist in interpretation of the test results

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).

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Infants born to hepatitis C virus (HCV) infected mothers may have false-reactive HCV antibody screening test results and false-positive HCV antibody confirmatory test results due to transplacental passage of maternal HCV-specific IgG antibodies). HCV antibody testing is not recommended until at least 18 months of age in these infants.


Performance characteristics of the EIA have not been established for the following types of serum specimen:

-Grossly hemolyzed (hemoglobin level of >800 mg/dL).

-Grossly icteric (total bilirubin level of >30 mg/dL).

-Grossly lipemic (triglyceride level of >3000 mg/dL).

-Presence of particulate matter

-Heat-treated specimens

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Carithers RL, Marquardt A, Gretch DR: Diagnostic testing for hepatitis C. Semin Liver Dis. 2000;20(2):159-171

2. Pawlotsky JM: Use and interpretation of virological tests for hepatitis C. Hepatology. 2002;36:S65-S73

3. 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

Special Instructions Library of PDFs including pertinent information and forms related to the test