Test Catalog

Test Id : HBGCD

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Hepatitis B Surface Antigen for Cadaveric or Hemolyzed Specimens, Serum

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Overview

Test Catalog

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

Testing cadaveric and hemolyzed blood specimens for hepatitis B surface antigen (HBsAg); US Food and Drug Administration-licensed for use with hemolyzed specimens

 

Diagnosis of acute, recent (<6-month duration), or chronic hepatitis B infection; determination of chronic hepatitis B carrier status

 

This test is not useful during the "window period" of acute hepatitis B virus (HBV) infection, (ie, after disappearance of HBsAg and prior to appearance of anti-HBs antibody).

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
BNTCD HBsAg Confirm Cadav/Hemol, S No No

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

All reactive results are confirmed by a neutralization procedure at an additional charge.

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

HBsAg Cadaver/Hemolyzed, S

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

HBsAg Cadaver

HBV Surface Antigen

Hep B

Hep B surface

Hep B surface antigen

Hepatitis Bs Ag

HBGCD

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

All reactive results are confirmed by a neutralization procedure at an additional charge.

Specimen Type
Describes the specimen type validated for testing

Serum

Additional Testing Requirements

Testing for acute hepatitis B virus (HBV) infection should also include HBIM / Hepatitis B Core Antibody, IgM, Serum as during the acute HBV infection "window period," HB surface (HBs) antigen and HBs antibody may not be detected.

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: 2 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.

Forms

If not ordering electronically, complete, print, and send a Gastroenterology and Hepatology 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. The minimum volume is sufficient for one attempt at testing.

1.5 mL

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

Gross hemolysis OK
Gross lipemia Reject
Gross icterus Reject

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
Ambient 7 days
Refrigerated 7 days

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

Testing cadaveric and hemolyzed blood specimens for hepatitis B surface antigen (HBsAg); US Food and Drug Administration-licensed for use with hemolyzed specimens

 

Diagnosis of acute, recent (<6-month duration), or chronic hepatitis B infection; determination of chronic hepatitis B carrier status

 

This test is not useful during the "window period" of acute hepatitis B virus (HBV) infection, (ie, after disappearance of HBsAg and prior to appearance of anti-HBs antibody).

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

All reactive results are confirmed by a neutralization procedure at an additional charge.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Hepatitis B virus (HBV) is endemic throughout the world. The infection is spread primarily through percutaneous contact with infected blood products (eg, blood transfusion, sharing of needles by intravenous drug users). The virus is found in various human body fluids, and it is known to be spread through oral and genital contact. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions; it is not commonly transmitted transplacentally.

 

Hepatitis B surface antigen (HBsAg) is the first serologic marker appearing in the serum at 6 to 16 weeks following HBV infection. In acute infection, HBsAg usually disappears in 1 to 2 months after the onset of symptoms. Persistence of HBsAg for greater than 6 months indicates development of either a chronic carrier or chronic HBV infection.

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 (reactive screening and confirmed positive by neutralization test) is indicative of acute or chronic hepatitis B virus (HBV) infection or chronic HBV carrier state.

 

A positive confirmatory test result is considered the definitive test result for hepatitis B surface antigen (HBsAg). Specimens that are reactive by the screening test but negative (not confirmed) by the confirmatory test are likely to contain cross-reactive antibodies from other infectious or immunologic disorders. These unconfirmed HBsAg screening test results should be interpreted in conjunction with test results of other HBV serological markers (eg, anti-hepatitis B surface antibody, anti-hepatitis B core total antibody).

 

The presence of HBsAg is frequently associated with HBV infectivity, especially when accompanied by the presence of HBeAg or HBV DNA.

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

Positive hepatitis B surface antigen (HBsAg) test results should be reported by the health care provider to the State Department of Health, as required by law in some states.

 

Individuals, especially neonates and children, who recently received hepatitis B vaccination may have transient-positive HBsAg test results because of the large dose of HBsAg used in the vaccine relative to the individual's body mass.

 

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

-Icteric cadavers

-Lipemic cadavers

-Containing particulate matter

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

1. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis. 2004 May;8(2):267-281

2. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol. 2001 Jun;21(3):229-237

3. Bonino F, Piratvisuth T, Brunetto MR, Liaw YF: Diagnostic markers of chronic hepatitis B infection and disease. Antivir Ther. 2010;15 Suppl 3:35-44

4. Terrault NA, Bzowej NH, Chang KM, et al: AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016 Jan;63(1):261-283

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

Specimens are first screened by the Genetic Systems hepatitis B surface antigen (HBsAg) 3.0 EIA. All reactive results are confirmed by the Genetic Systems HBsAg Confirmatory Assay 3.0 (HBsAg Neutralization) at an additional charge.

 

HBsAg:

The Bio-Rad GS HBsAg EIA 3.0 is a qualitative third-generation enzyme immunoassay which uses mouse monoclonal antibodies to detect anti-HBsAg in human serum or cadaveric serum specimens. Wells of a microwell strip plate are coated with mouse monoclonal antibody to HBsAg (anti-HBs). Patient serum and appropriate controls are added to the wells and incubated with bound antibody. If HBsAg is present, it will bind to the antibody and not be removed by washing. The strips are washed to remove any unbound material. Washing is followed by the addition of conjugate solution (peroxidase-conjugated mouse monoclonal antibodies directed against HBsAg). The conjugate solution will bind to the antibody-HBsAg complex, if present. Unbound conjugate is removed by a wash step. Next, working 3,3',5,5'-tetramethylbenzidine (TMB) solution is added to the plate and allowed to incubate. A blue or blue-green color develops in proportion to the amount of HBsAg present in the sample. The enzyme reaction is stopped by the addition of acid, which changes the blue-green color to yellow. The absorbance values of controls and specimens are determined using a spectrophotometer with wavelength set at 450 nm.(Package insert: Genetic Systems HBsAg 3.0 EIA. Bio-Rad Laboratories; 02/2019)

 

HBsAg Confirmation:

The repeatedly reactive specimen is incubated with HBsAg confirmatory reagent (human antibody to HBsAg). If HBsAg is present in the specimen, it will be neutralized by the HBsAg confirmatory reagent. The treated specimen is re-assayed using the Genetic Systems HBsAg 3.0 EIA assay. The neutralized HBsAg is prevented from binding to the HBsAg antibody-coated microwells, which results in a reduction of signal. A non-neutralized control of the specimen (treated with HBsAg-negative control [human] in place of the HBsAg confirmatory reagent) is tested in parallel to the neutralized specimen for comparison of signal. Genetic Systems HBsAg EIA 3.0 repeatedly reactive specimens are confirmed as positive by the Genetic Systems HBsAg Confirmatory Assay 3.0 if the reduction in signal of the neutralized specimen is greater than or equal to 50% of the corresponding non-neutralized specimen, and the non-neutralized specimen signal is greater than or equal to the assay cutoff.(Package insert: Genetic Systems HBsAg Confirmatory Assay 3.0. Bio-Rad Laboratories; 01/2009)

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 account representative. 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.

87340

87341 (if appropriate)

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
HBGCD HBsAg Cadaver/Hemolyzed, S In Process
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.
83626 HBsAg Cadaver/Hemolyzed, S 5196-1

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