Test ID: HBGCD
Hepatitis Bs Antigen (HBsAg) for Cadaveric or Hemolyzed Specimens, Serum
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
Testing cadaveric and hemolyzed blood specimens for hepatitis B surface antigen; FDA-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
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 |
|---|---|---|---|
| BNTCD | HBsAg Confirm Cadav/Hemol, S | No | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
All reactive HBsAg EIA results are confirmed by HBsAg neutralization at an additional charge.
Method Name A short description of the method used to perform the test
Enzyme Immunoassay (EIA)
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
HBV Surface Antigen
Hep B
Hep B surface
Hep B surface antigen
Hepatitis Bs Ag
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
Additional Information: Date of draw is required.
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 reject; Gross reject |
| Icterus | Mild reject; 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) | |
| Ambient | 7 days | |
| Refrigerated | 7 days | |
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 addicts). The virus is also found in various human body fluids, and it is known to be spread through oral and genital contacts. HBV can be transmitted from mother to child during delivery through contact with blood and vaginal secretions, but 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 >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; see Method Description) is indicative of acute or chronic hepatitis B virus (HBV) infection, or chronic HBV carrier state.
A positive (confirmed) neutralization 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 neutralization 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 hepatitis Be antigen and/or HBV DNA.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is not useful during the "window period" of acute hepatitis B virus (HBV) infection, (ie, after disappearance of hepatitis B surface antigen [HBsAg] and prior to appearance of anti-HBs antibody). Testing for acute hepatitis B virus infection should also include anti-hepatitis B core IgM antibody.
Positive 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
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Servoss JC, Friedman LS: Serologic and molecular diagnosis of hepatitis B virus. Clin Liver Dis 2004;8:267-281
2. Badur S, Akgun A: Diagnosis of hepatitis B infections and monitoring of treatment. J Clin Virol 2001 Jun;21(3):229-237
Method Description Describes how the test is performed and provides a method-specific reference
Specimens are first screened by the Genetic Systems HBsAg 3.0 EIA. All reactive results are confirmed by the Genetic Systems HBsAg Confirmatory Assay 3.0 (HBsAg Neutralization) at an additional charge.
EIA
Wells of a microwell strip plate that are coated with mouse monoclonal antibody to hepatitis B surface antigen (HBsAg) are incubated with patient serum appropriate controls and mouse monoclonal anti-hepatitis B surface (anti-HBs) peroxidase conjugate. HBsAg, if present, is bound to the solid-phase antibody and simultaneously bound by the anti-HBs conjugate. After aspiration and washing, working chromogen solution is added to the wells. After incubation, a blue or blue-green color develops in proportion to the amount of HBsAg bound to the bead.
The enzyme reaction is stopped by the addition of acid resulting in a color change to yellow. The absorbance values of controls and specimens are determined using a spectrophotometer with wavelength set at 450 nm. Specimens giving absorbance values equal to or greater than the absorbance value of the negative control mean plus a factor are considered initially reactive for HBsAg. Those giving absorbance values less than the negative control mean plus a factor are considered negative. (Package insert: Genetic Systems HBsAg 3.0 EIA. Bio-Rad Laboratories, Redman, WA)
Neutralization
The Genetic Systems HBsAg Confirmatory Assay 3.0 uses the principle of specific antibody neutralization to confirm the presence of HBsAg. The confirmatory reagent (human antibody to HBsAg) is incubated with the specimen in solution. If HBsAg is present in the specimen, it will be bound by the confirmatory reagent. The treated specimen is reassayed using the Genetic Systems HBsAg 3.0 EIA kit. The neutralized HBsAg is subsequently blocked from binding to the antibody-coated wells. This results in a reduction of signal when compared to the nonneutralized specimen in which negative control is used in place of confirmatory reagent. By definition, a specimen is confirmed as positive if the reduction in signal of the neutralized specimen is at least 50% and the nonneutralized control generates a signal greater than or equal to the assay cutoff. (Package insert: Genetic Systems HBsAg Confirmatory Assay 3.0. Bio-Rad Laboratories, Redman, WA)
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.
87340-HBsAg
87341-HBsAg neutralization (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 |
|---|---|---|
| 83626 | HBsAg Cadaver/Hemolyzed, S | 5196-1 |
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