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.

Highlights

Indicated for testing asymptomatic individuals (screening purposes) with or without risk factors for hepatitis C virus infection.

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

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

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

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

Method Name
A short description of the method used to perform the test

Enzyme Immunoassay (EIA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HCV Ab Cadaver/Hemolyzed Screen, S

Aliases
Lists additional common names for a test, as an aid in searching

Anti-HCV (Hepatitis C Virus)

HCV (Hepatitis C Virus) Antibody

HCV (Hepatitis C Virus) Supplemental Test

HCV Antibody

Hepatitis C Antibody

Hepatitis C Virus

Non-A, Non-B Hepatitis

Hepatitis C (HCV)

Antibody to Hepatitis C Virus

HCCAD

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

Specimen Type
Describes the specimen type validated for testing

Serum

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 in Cadaveric or Hemolyzed Specimens, Symptomatic, Serum.

Necessary Information

Date of collection is required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

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

Forms

If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology Client Test Request (T728) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.2 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

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

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.

Negative

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

Method Description
Describes how the test is performed and provides a method-specific reference

The ORTHO HCV Version 3.0 ELISA Test System is a 3-stage test carried out in a microwell coated with a combination of recombinant hepatitis C virus (HCV) antigen (c22-3, c200 and NS5). In the first stage, a diluted test specimen or appropriate controls are incubated in the test well for a specified length of time. If antibody reactive to any of the 3 antigens is present in the specimen, antigen-antibody complexes will be formed on the microwell surface. If anti-HCV is not present, complexes will not be formed. In the subsequent washing step, unbound serum proteins will be removed. In the second stage, murine monoclonal antibody conjugated to horseradish peroxidase is added to the microwell. The conjugate binds specifically to the human IgG portion of the antigen-antibody complexes. If antigen-antibody complexes are not present, the unbound conjugate will be removed by subsequent washing. In the third stage, an enzyme detection system composed of o-phenylenediamine (OPD) and hydrogen peroxide is added to the test well. If bound conjugate is present, the OPD will be oxidized, resulting in a colored end product. In this reaction, peroxidase is divalently oxidized by hydrogen peroxide to form an intermediate compound, which is, in turn, reduced to its initial state by subsequent interaction with hydrogen ion donating OPD. The resulting oxidized form of OPD has an orange color. Sulfuric acid is then added to stop the reaction. The color intensity is dependent upon the amount of bound conjugate and  is a function of the concentration of anti-HCV present in the specimen. The color intensity is measured with a microwell reader (photometer) designed to measure light absorbance in a microwell. (Package insert: Hepatitis C Virus Encoded Antigen [Recombinant c22-3, c200, and NS5], ORTHO HCV Version 3.0 ELISA Test System. Ortho Clinical Diagnostics; 01/2017)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday, Thursday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86803

G0472

86804 (if appropriate)

LOINC® 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
Result LOINC Value Tooltip
87858 HCV Ab Cadaver/Hemolyzed Screen, S 13955-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports