Test ID: HCV
Hepatitis C Antibody Screen, 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 for past (resolved) or chronic hepatitis C
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
The following algorithms are available in Special Instructions:
-Testing Algorithm for the Diagnosis of Hepatitis C
-Viral Hepatitis Serologic Profiles
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Chemiluminescence Immunoassay
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
HCVAB, Serum
Hepatitis C Viral Antibody, Serum
Anti-HCV (Hepatitis C Virus)
Non-A, non-B Hepatitis
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: 1 mL
Collection Instructions: Spin down within 6 hours of draw.
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
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 reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross reject |
| 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) | |
| Refrigerated | 7 days | |
| Ambient | 24 hours | |
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.
Laboratory testing for HCV infection usually begins by screening for the presence of HCV antibodies (anti-HCV) in serum, using an FDA-approved anti-HCV screening test. Specimens that are repeatedly reactive by screening tests should be confirmed by more HCV-specific tests, such as direct detection of HCV RNA by reverse transcriptase-PCR (RT-PCR) or strip recombinant immunoblot assay (RIBA) using recombinant HCV-specific antigens.
HCV antibodies are usually not detected during the first 2 months following infection and are almost always detectable by the late convalescent stage (>6 months after onset) of infection. These antibodies do not neutralize the virus, and they do not provide immunity against this viral infection. Loss of HCV antibodies may occur several years following resolution of infection.
Current screening serologic tests to detect HCV antibodies include EIA and chemiluminescence immunoassay. Despite the value of serologic tests to screen for HCV infection, several limitations of serologic testing exist:
-There may be a long delay (up to 6 months) between exposure to the virus and the development of detectable HCV antibodies.
-False-reactive screening test results can occur.
-A reactive screening test result does not distinguish between past (resolved) and chronic HCV infection.
-Serologic tests cannot provide information on clinical response to anti-HCV therapy.
Reactive screening test results should be followed by a supplemental or confirmatory test, such as RIBA for HCV antibodies or nucleic acid tests for HCV RNA. Nucleic acid tests provide a very sensitive and specific approach for the direct detection of HCV RNA.
The following algorithms are available in Special Instructions:
-Viral Hepatitis Serologic Profiles
-Testing Algorithm for the Diagnosis of Hepatitis C
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 depends on clinical setting.
See Viral Hepatitis Serologic Profiles in Special Instructions.
Interpretation Provides information to assist in interpretation of the test results
Reactive hepatitis C virus (HCV) antibody screening results with signal-to-cutoff (S/CO) ratios of <8.0 are not predicative of the true HCV antibody status, and additional testing is recommended to confirm anti-HCV status. Reactive results with S/CO ratios of > or =8.0 are highly predictive (> or =95% probability) of the true anti-HCV status, but additional testing is needed to differentiate between past (resolved) and chronic hepatitis C.
To confirm results of HCV antibody screening test and to guide further management of patients, specimens should be tested by 1 of the following supplemental tests:
-HCVQU Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum for patients with known risk factors for HCV infection. Presence of HCV RNA in a given specimen indicates acute or chronic hepatitis C.
-RIBA/80181 Hepatitis C Virus Antibody Confirmation by Recombinant Immunoblot Assay (RIBA), Serum for patients with minimal or no risk factors for HCV infection. A positive RIBA result confirms the presence of HCV IgG antibodies, but it does not 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 results in individuals with prior exposure to HCV may be due to low antibody levels that are below the limit of detection of this assay or lack of reactivity to the HCV antigens used in this assay. Patients with acute or recent HCV infections (<3 months from time of exposure) may have false-negative HCV antibody test results due to the time needed for seroconversion (average of 8 to 9 weeks). Testing for HCV RNA (HCVQU Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum) is recommended for detection of HCV infection in such patients.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is not offered as hepatitis C virus (HCV) screening or confirmatory testing for organ, blood, or human cell/tissue donors.
Indicate if specimens are from autopsy/cadaver or hemolyzed sources so that the proper FDA-licensed assay can be performed.
HCV serologic tests are not useful for detection of early or acute HCV infection, and they are not useful for differentiating between past (resolved) and chronic hepatitis C. Testing for HCV RNA (HCVQU Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum) is recommended for detection of acute HCV infection.
Infants born to HCV-infected mothers may have false-reactive HCV antibody test results due to transplacental passage of maternal HCV IgG antibodies. HCV antibody testing is not recommended until at least 18 months of age in these infants.
Performance characteristics have not been established for the following types of serum specimen:
-Individuals of <10 years of age
-Grossly icteric (total bilirubin level of >20 mg/dL)
-Grossly lipemic (triolein level of >3,000 mg/dL)
-Grossly hemolyzed (hemoglobin level of >500 mg/dL)
-Presence of particulate matter
-Cadaveric specimens
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(RR-3):1-13
3. Germer JJ, Zein NN: Advances in the molecular diagnosis of hepatitis C and their clinical implications. Mayo Clin Proc 2001;76(9):911-920
4. 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 VITROS anti-hepatitis C virus (HCV) chemiluminesence immunoassay is performed using the VITROS Anti-HCV Reagent Pack and VITROS Immunodiagnostic Products Anti-HCV Calibrator on the VITROS 3600 Immunodiagnostic System (Ortho-Clinical Diagnostics, Inc., Raritan, NJ). An immunometric technique is used, involving a 2-stage reaction. In the first stage, HCV antibody present in the sample binds to HCV recombinant antigens coated on the reaction wells, and unbound sample is removed by washing. In the second stage, horseradish peroxidase (HRP)-labeled antibody conjugate (mouse monoclonal antihuman IgG) binds to any human IgG captured on the well in the first stage. Unbound conjugate is removed by washing. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent increases the level and duration of the light produced. The emitted light signals are detected and measured by the VITROS 3600 Immunodiagnostic System. The amount of HRP conjugate bound is directly proportional to the level of anti-HCV antibodies present in a given sample.(Ismail N, Fish GE, Smith MB: Laboratory evaluation of a fully automated chemiluminescence immunoassay for rapid detection of HBsAg, antibodies to HBsAg, and antibodies to hepatitis C virus. J Clin Microbiol 2004;42:610-617)
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 through Saturday; 8 a.m.-12:30 a.m.
Sunday; 8 a.m.-4:30 p.m.
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
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 |
|---|---|---|
| HCVA | HCV Ab Screen, S | 16128-1 |
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