Test ID: HCCAD
Hepatitis C Virus Antibody Screen for Cadaveric or Hemolyzed Specimens, Serum
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Screening cadaveric or hemolyzed serum specimens for hepatitis C virus-specific antibodies
Note: This test is not intended for screening blood, cell, or tissue donors.
Reflex Tests Lists test(s) that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| RIBA | HCV Ab Confirmation by RIBA, S | Yes | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
If hepatitis C virus (HCV) antibody screen is reactive with a single-to-cutoff ratio of > or =1.0, then HCV antibody confirmation by RIBA will be performed at an additional charge. The RIBA is not FDA-approved for testing cadaveric or hemolyzed specimens. A disclaimer will be added to all RIBA tests performed on cadaveric (or hemolyzed) specimens.
Method Name A short description of the method used to perform the test
HCCAD/87858: Enzyme Immunoassay (EIA)
RIBA/80181: Recombinant Immunoblot Assay (RIBA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Anti-HCV RIBA (Hepatitis C Virus Recombinant Immunoblot Assay)
Antibody to Hepatitis C Virus
HCV (Hepatitis C Virus) Antibody
HCV (Hepatitis C Virus) Supplemental Test
HCV Antibody
HCV RIBA (Hepatitis C Virus Recombinant Immunoblot Assay)
Hepatitis C Antibody
Hepatitis C Confirmation (RIBA)
Hepatitis C Virus
Hepatitis C Virus Recombinant Immunoblot Assay (HCV RIBA)
Non-A, Non-B Hepatitis
Hepatitis C (HCV)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross OK |
| Lipemia | Mild OK; Gross OK |
| Icterus | Mild OK; Gross OK |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum SST | Frozen (preferred) | |
| Ambient | 7 days | |
| Refrigerated | 7 days | |
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 3.5 to 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 recombinant immunoblot assay (RIBA) for HCV antibodies or 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 or hemolyzed serum 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 reactive screening test results and signal-to-cutoff ratios of > or =1.0 will be reflexed to the hepatitis C virus (HCV) antibody confirmatory test by recombinant immunoblot assay (RIBA) 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.
Not useful for ruling out acute HCV infection.
Not useful for differentiation between resolved and acute or chronic hepatitis C infection.
Performance characteristics of the EIA have not been established for the following types of serum specimen:
-Grossly hemolyzed (hemoglobin level of >800 mg/dL). Hemolyzed specimens with hemoglobin level of < or =800 mg/dL will be accepted and tested.
-Grossly icteric (total bilirubin level of >30 mg/dL). Icteric specimens with total bilirubin levels < or =30 mg/dL will be accepted and tested.
-Grossly lipemic (triglyceride level of >3,000 mg/dL). Lipemic specimens with a triglyceride level of < or =3,000 mg/dL will be accepted and tested.
-Presence of particulate matter
Clinical Reference Provides recommendations for further 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. Alter MJ, Kuhnert WL, Finelli L: Centers for Disease Control and Prevention: Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. MMWR Morb Mortal Wkly Rep 2003;52(No. RR-3):1-14
3. Pawlotsky JM: Use and interpretation of virological tests for hepatitis C. Hepatology 2002;36:S65-S73
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 (rHCV) 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. The amount of oxidized OPD, which has a yellow-orange color, is proportional to the amount of anti-HCV that is bound to the well. The enzyme reaction is stopped by the addition of sulfuric acid and the intensity of color developed is read using a spectrophotometer. Samples with absorbance values equal to or greater than the cutoff are considered initially reactive for antibody to HCV, but before they are reported as positive, the specimen is retested in duplicate. (Package insert: Hepatitis C Virus Encoded Antigen (Recombinant c22-3, c200, and NS5) ORTHO HCV Version 3.0 ELISA Test System Ortho Clinical Diagnostics, Inc. Raritan, NJ)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday, Wednesday, Friday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86803–Hepatitis C antibody screen
86804–Hepatitis C antibody RIBA (if appropriate)
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| 87858 | HCV Ab Cadaver/Hemolyzed Screen, S | 13955-0 |
External
link
PDF
document
Excel
document
Word
document