Hepatitis C Antibody Screen Patient Source, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Detection and diagnosis of chronic hepatitis C virus infection
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|
|PHCPS||HCV RNA Pt Source, 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, then HCV RNA by reverse transcriptase-polymerase chain reaction (RT-PCR) will be performed at an additional charge.
HCVPS/13009: Chemiluminescence Immunoassay
PHCPS/13017: Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
HCV Ab Screen Patient Source, S
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: 2 mL
Collection Instructions: Aseptically spin specimen down within 6 hours of draw, immediately refrigerate specimen, and freeze specimen in a plastic vial within 12 hours of draw.
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.
Gross hemolysis reject
Gross lipemia reject
Gross icteric reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
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 a 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 transcription-PCR (RT-PCR) or strip recombinant immunoblot assay (RIBA) using recombinant HCV-specific antigens.
HCV antibodies are usually not detectable during the first 2 months following infection, but they are usually 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 in the year following resolution of infection.
Current screening serologic tests to detect antibodies to HCV include EIA and chemiluminescence immunoassay (CIA). 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 a detectable HCV antibody
-False-reactive screening test result 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 anti-HCV therapy
Reactive screening test results should be followed by a supplemental or confirmatory test, such as RIBA for HCV antibodies or a nucleic acid test for HCV RNA. Nucleic acid tests provide a very sensitive and specific approach for the direct detection of HCV RNA.
See Recommended Approach to the Diagnosis and Monitoring of Patients with Hepatitis C Virus in Special Instructions.
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.
HCV ANTIBODY SCREEN PATIENT SOURCE
Negative (reported as reactive or negative)
HEPATITIS C RT-PCR
Negative for HCV-RNA
If positive, reported as positive for HCV-RNA
Screening test (CIA):
Reactive hepatitis C virus (HCV) antibody screening results with signal-to-cutoff (S/CO) ratios of <8.0 are not predictive 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.
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 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 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).
The quantification range of this test is 43 IU/mL to 69,000,000 IU/mL.
Negative results indicate that HCV RNA is not detected in the serum.
A titer result indicates the presence of HCV infection with active viral replication.
Positive results with the comment of "HCV RNA detected, but less than 43 IU/mL" indicate that the HCV RNA present is at a level below the quantifiable lower limit of this assay. Follow-up testing by this assay is recommended in 1 to 3 months.
Positive results with the comment of "but greater than 69,000,000 IU/mL" indicate that the level of HCV RNA present is above the quantifiable upper limit of this assay.
A single negative HCV RNA result with positive anti-HCV antibody status (assay signal-to-cutoff ratio of > or =3.8 by EIA, or > or =8.0 by chemiluminescence immunoassay [CIA]), does not necessarily indicate past or resolved HCV infection. Individuals with such results should be retested for HCV RNA in 1 to 2 months, to distinguish between patients with past/resolved HCV infection and those with chronic HCV infection having episodic HCV replication.
Presence of anti-HCV antibodies (assay signal-to-cutoff ratio of <3.8 by EIA or <8.0 by CIA) in individuals with negative HCV RNA results may be confirmed by RIBA/80181 Hepatitis C Virus Antibody (Anti-HCV) Confirmation, Serum.
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.
This test profile is not useful for detection or diagnosis of acute hepatitis C, since HCV antibodies may not be detectable until after 2 months following exposure and HCV RNA testing is not performed on specimens with negative anti-HCV screening test results.
A single negative HCV RNA test result together and a reactive HCV antibody screen result with a S/CO ratio of > or =8.0 do not rule out the possibility of chronic HCV infection. Repeat testing for HCV RNA in 1 to 2 months is recommended in patient at risk for chronic hepatitis C.
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 less than 10 years of age 13009 (HCVPS)
-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
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. 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
Chemiluminescent Immunoassay (CIA):
The VITROS anti-HCV assay is performed using the VITROS Anti-HCV Reagent Pack and VITROS Immunodiagnostic Products Anti-HCV Calibrator on the VITROS ECi Immunodiagnostic System (Ortho-Clinical Diagnostics, Inc., Raritan, NJ). An immunometric technique is used, involving a 2-stage reaction. In the first stage, hepatitis C virus (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 human IgG captured on the well in the first stage. Unbound conjugate is removed by washing. A reagent containing luminogenic substrates (a luminal 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 luminal 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 ECi 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 MN: 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)
The COBAS AmpliPrep/COBAS TaqMan HCV Test is a Food and Drug Administration (FDA)-approved in vitro assay based on an automated method (AmpliPrep) for nucleic acid extraction and purification and a homogeneous (real-time) PCR method (TaqMan) for amplifying the HCV-specific 5' UTR sequence (241 bp size) and generating a signal by cleaving a target-specific TaqMan probe during amplification. The probe contains a reporter fluorophore and a quencher dye that absorbs light emitted by the reporter. Cleavage of the probe physically separates the quencher from the reporter, enabling light emitted by the latter to be detected by a photomultiplier tube. Because amplification and detection are performed simultaneously, amplification products are measured during the exponential phase of DNA amplification regardless of the initial target concentration. (Package insert: COBAS AmpliPrep/COBAS TaqMan HCV Test; Roche Molecular Systems, Inc., Branchburg, NJ)
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.
This test has been cleared or approved by the U.S. 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 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 patient source
87522-Hepatitis C patient source, RT-PCR (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|
|HCV2||HCV Ab Screen Patient Source, S||In Process|