Test Catalog

Test Id : HCVL

Hepatitis C Virus Antibody Confirmation, Serum

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

Confirming the presence of hepatitis C virus (HCV)-specific IgG antibodies in serum specimens that are reactive by HCV antibody screening tests

 

Distinguishing between true- and false-reactive HCV antibody screening test results

 

This test is not intended for use as an HCV antibody screening test for blood or human cells/tissue donors

 

This assay is not useful for detection of early or acute hepatitis C (<2 months from exposure) as immunocompromised patients may not develop detectable HCV antibodies in blood until 6 months after infection

 

This assay is not useful for differentiating between past (resolved) and chronic hepatitis C

Highlights

This test is indicated for individuals with reactive hepatitis C virus (HCV) antibody results but undetectable HCV RNA levels.

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

This test is available as a confirmatory test for reactive Hepatitis C virus (HCV) antibody screening test results.

 

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

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

Line Immunoassay (LIA)

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 Confirmation, S

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

Anti-HCV Confirmation

HCV Antibody Supplemental Test

HCVL

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

This test is available as a confirmatory test for reactive Hepatitis C virus (HCV) antibody screening test results.

 

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

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

This test does not differentiate between past (resolved) and chronic hepatitis C. To distinguish between past (resolved) and chronic hepatitis C, order HCVQN / Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum.

 

For screening of asymptomatic individuals for HCV, order HCSRN / Hepatitis C Virus (HCV) Antibody Screen with Reflex to HCV RNA, PCR, Asymptomatic, Serum.

 

For detection of HCV in symptomatic at-risk individuals, order HCVDX / Hepatitis C Virus (HCV) Antibody with Reflex to HCV RNA, PCR, Symptomatic, Serum.

Necessary Information

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: 0.4 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot 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 1 of the following:

-Gastroenterology and Hepatology Client Test Request (T728)

-Infectious Disease Serology Test Request (T916)

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

0.1 mL

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

Gross hemolysis Reject
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) 30 days
Refrigerated 7 days

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

Confirming the presence of hepatitis C virus (HCV)-specific IgG antibodies in serum specimens that are reactive by HCV antibody screening tests

 

Distinguishing between true- and false-reactive HCV antibody screening test results

 

This test is not intended for use as an HCV antibody screening test for blood or human cells/tissue donors

 

This assay is not useful for detection of early or acute hepatitis C (<2 months from exposure) as immunocompromised patients may not develop detectable HCV antibodies in blood until 6 months after infection

 

This assay is not useful for differentiating between past (resolved) and chronic hepatitis C

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

This test is available as a confirmatory test for reactive Hepatitis C virus (HCV) antibody screening test results.

 

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

Laboratory testing for hepatitis C virus (HCV) infection in patients and donors of organ, blood, cells, tissue, and tissue products 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 the reverse transcriptase-polymerase chain reaction (RT-PCR) assay or confirmatory detection of HCV antibodies by serologic assays using recombinant HCV-specific antigens. In patients with reactive HCV antibody screening test results but negative or undetectable HCV RNA test results, HCV antibody confirmatory tests would be useful to distinguish between true- and false-reactive HCV antibody screening test results.

 

HCV antibodies are usually not detectable during the first 2 months following infection, and 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 years following resolution of infection.

 

Despite the value of serologic confirmation of HCV infection, several limitations of this test exist:

-There may be a long delay (up to 6 months) between exposure to the virus and development of detectable HCV antibodies, especially in immunocompromised patients

-A positive test result does not distinguish between past (resolved) and chronic HCV infection

-Serologic tests cannot predict or monitor response to antiviral therapy

 

See Hepatitis C: Testing Algorithm for Screening and Diagnosis 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.

Negative

Interpretation
Provides information to assist in interpretation of the test results

A positive result indicates the presence of hepatitis C virus (HCV)-specific IgG antibodies due to past (resolved) or chronic hepatitis C. Past (resolved) HCV infection (accounting for about 25% of all HCV-infected patients) can be distinguished from chronic HCV infection (about 75% of all cases) only by direct detection of HCV RNA using molecular test methods; eg, HCVQN / Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum. HCV RNA is present in acute or chronic hepatitis C but not in past (resolved) HCV infection.

 

A negative result indicates the absence of HCV-specific IgG antibodies. A reactive HCV antibody screening test result with a negative HCV antibody confirmatory result indicates a probable false-reactive screening test result.

 

An indeterminate result indicates that HCV-specific IgG antibodies may or may not be present. Indeterminate results should be interpreted along with patient's risk factors for HCV infection and clinical findings. Individuals at risk for HCV infection with indeterminate results should be retested with an HCV antibody confirmatory test in 1 to 2 months to determine the definitive HCV antibody status. Molecular tests to detect HCV RNA may be necessary to determine HCV infection status in those at-risk immunocompromised patients with indeterminate HCV antibody confirmatory test results due to delayed appearance of fully complement of HCV-specific antibodies.

 

An unreadable result indicates nonspecific cross reactivity was present and HCV-specific antibody bands could not be visualized reliably. Repeat confirmatory serologic testing in 1 to 2 months or HCV RNA (HCVQN / Hepatitis C Virus [HCV] RNA Detection and Quantification by Real-Time Reverse Transcription-PCR [RT-PCR], Serum) is recommended for at-risk patients.

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

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

-Cadaveric specimens

-Grossly hemolyzed (hemoglobin level of >100 mg/dL)

-Presence of particulate matter

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

1. American Association for the Study of Liver Diseases/Infectious Diseases Society of America/International Antiviral Society-USA. Recommendations for Testing, Managing, and Treating Hepatitis C. Accessed January 27, 2015. Available at www.hcvguidelines.org

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

3. Pawlotsky JM: Use and interpretation of hepatitis C virus diagnostic assays. Clin Liver Dis. 2003;7:127-137

4. 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. Accessed April 2020. Available at www.cdc.gov/mmwr/preview/mmwrhtml/rr5203a1.htm

5. Centers for Disease Control and Prevention: Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep. 2013;62:362-365

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 MP Diagnostics Hepatitis C Virus (HCV) Blot 3.0 is a line immunoassay that utilizes a nitrocellulose strip containing 4 bands corresponding to recombinant HCV proteins derived from the capsid (C), NS3, NS4, and NS5 regions of the HCV genome. The HCV proteins are expressed as glutathione-S-transferase (GST) fusion proteins, so a GST control band is also present on each strip to indicate reactivity to native GST. Each strip also contains an IgG control band and an anti-IgG band. Individual strips are incubated with either diluted clinical serum specimens or assay controls. Specific antibodies to HCV, if present in the specimen, will bind to the HCV proteins on the strips. The strips are washed to remove unbound materials and then incubated with affinity purified antihuman IgG conjugated with alkaline phosphatase. The conjugated antibody will bind to any antigen-antibody complexes formed on the strips. Unbound conjugate is removed by washing. A BCIP/NBT (5-bromo-4-chloro-3-indolyl-phosphate/nitro blue tetrazolium) substrate is added to visualize reactive protein bands on the strips.(Package insert: MP Diagnostics HCV Blot 3.0. MP Biomedicals Asia Pacific Pte Ltd; Publ. MAD 0012-ENG-2, 10/2010)

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.

Wednesday

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 14 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 was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

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.

86804

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HCVL HCV Ab Confirmation, S 40726-2
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
63063 HCV Ab Confirmation, S 40726-2

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