Test ID: HEPB
Hepatitis B Profile, 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
Determining whether a patient has been exposed to hepatitis B virus (HBV)
Monitoring patients recovering from HBV infection
Diagnosis of HBV infection, although HBIS/209102 Hepatitis B Immune Status Profile, Serum may be more conclusive
Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HBAG | HBs Antigen, S | Yes | Yes |
| CORAB | HBc Total Ab, w/Reflex, S | Yes | Yes |
| HBAB | HBs Antibody, S | Yes | Yes |
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 |
|---|---|---|---|
| HBGNT | HBs Antigen Confirmation, S | No | No |
| HBIM | HBc IgM Ab, S | Yes | No |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
Confirmatory testing will be performed at an extra charge on all reactive Hepatitis B Surface Antigen prenatal specimens as well as all other reactive specimens that have a signal-to-cutoff ratio (S/CO) of < or =50.0.
Specimens with an S/CO of >50.0 that are not prenatal specimens do not require confirmation.
If hepatitis Bc antibody total is positive, then hepatitis Bc antibody IgM is performed at an additional charge.
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 (CIA)
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
HEPB Profile, Serum
33188-HEPB
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: Red top or serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 3 mL
Collection Instructions: Spin down and remove serum from clot within 24 hours.
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 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 B is endemic throughout the world. The infection is spread primarily through percutaneous contact with infected blood products, eg, blood transfusion, sharing of needles by drug addicts. The virus is also found in virtually every type of human body fluid and has been known to be spread through oral and genital contact. Hepatitis B virus (HBV) can be transmitted from mother to child during delivery through contact with blood and vaginal secretions; it is not commonly transmitted transplacentally.
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.
HEPATITIS B SURFACE ANTIGEN
Negative
HEPATITIS B CORE TOTAL ANTIBODY
Negative
HEPATITIS B SURFACE ANTIBODY
Unvaccinated: negative
Vaccinated: positive
HEPATITIS B SURFACE ANTIBODY, QUANTITATIVE
Unvaccinated: <5.0
Vaccinated: > or =12.0
Interpretation depends on clinical setting.
See Viral Hepatitis Serologic Profiles in Special Instructions.
Interpretation Provides information to assist in interpretation of the test results
Presence of hepatitis B surface antigen (HBsAg) in serum may indicate acute hepatitis B virus (HBV) infection, chronic HBV infection, or asymptomatic carrier state. The significance of HBsAg in serum is determined by evaluating it in relationship to the presence or absence of the other HBV markers and the clinical presentation and history of the patient.
Before the onset of clinical illness, HBsAg is detectable in the serum and its presence persists through the symptomatic phase of illness. Following clinical illness, the titer of HBsAg begins to decline and eventually falls below a detectable level. After HBsAg disappears, hepatitis B surface antibody (anti-HBs) appears in the serum, although there is often a gap called the "window period" between the disappearance of HBsAg and the appearance of anti-HBs. In approximately 10% of patients, HBsAg persists indefinitely in the serum, indicating a chronic carrier state, and anti-HBs does not appear.
During the course of a typical case of acute hepatitis B infection, hepatitis B core antibody (anti-HBc) is present in the serum shortly before clinical symptoms appear. It is detectable during prodromal, acute, and early convalescent phases where it exists as immunoglobulin M (IgM) anti-HBc. Total anti-HBc (IgG and IgM) rises in titer and is present during the "window period," ie, after HBsAg disappears and before anti-HBs appears. For this reason, in the absence of other HBV markers, total anti-HBc is considered a reliable indicator of ongoing infection. It is also an accurate serological marker of previous HBV infection, as it appears in all patients infected with the HBV and may persist in individuals at low titer (as IgG anti-HBc) long after HBV exposure. Although total anti-HBc is a long-lived antibody, in some cases total anti-HBc titers, along with total anti-HBs, may fall into the undetectable range.
In subclinical asymptomatic HBV infection, HBsAg and hepatitis Be antigen (HBeAg) are present for a brief period or may not be detectable and are followed by the appearance of anti-HBc and anti-HBs. In these patients, detection of total anti-HBc and total anti-HBs must be relied on as evidence of previous HBV infection.
In chronic HBV, HBsAg appears during the incubation phase of the disease and may persist for years and possibly for life. Total anti-HBc also appears during this early phase and rises in titer. The highest titers of total anti-HBc are found in the chronic HBsAg carrier state. Total anti-HBc may be negative or undetectable in serum or plasma during the early acute phase of HBV infection and long after infection resolution, when titers may fall.
The presence of anti-HBs in serum indicates previous exposure to HBV and acquired immunity. Low titers of anti-HBs in serum, however, can signal a lack of immunity to future HBV infection. The clinical relevance of anti-HBs detection is in establishing complete resolution of the infection and the acquisition of immunity, whether acquired as a result of natural HBV infection or vaccination. Anti-HBs may fall below detectable levels with time.
See Viral Hepatitis Serologic Profiles in Special Instructions.
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 result should be reported by the attending physician to the State Department of Health as required by law in some states.
A weakly positive anti-hepatitis B core (HBc) test result unaccompanied by other hepatitis B serologic markers, elevated liver enzymes, or a history of risk factors may be a false-positive result.
Passively acquired anti-hepatitis B surface (HBs) (ie, transfusion, recent immune globulin treatment, etc) does not signify immunity.
Anti-HBs may fall below detectable levels with time.
Performance characteristics have not been established for the heat inactivated specimens or specimens containing particulate matter.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Kubo S, Nishiguchi S, Hirohashi K, et al: Clinical significance of prior hepatitis B virus infection in patients with hepatitis C virus-related hepatocellular carcinoma. Cancer 1999 September 1:86(5):793-798
2. Schiff ER: Lamivudine for hepatitis B in clinical practice. J Med Virol 2000 July;61(3):386-391
3. Sherlock S: Hepatitis B: the disease. Vaccine 1990;8 Suppl:S6-S9
Method Description Describes how the test is performed and provides a method-specific reference
See individual unit codes.
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 Friday, Sunday
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.
86704-Hepatitis Bc Ab (HBcAb), total
86706-Hepatitis Bs Ab (HBsAb)
87340-Hepatitis Bs Ag (HBsAg)
86705-Hepatitis Bc Ab (HBcAb), IgM (if appropriate)
87341-Hepatitis Bs Ag (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 |
|---|---|---|
| CORAB | HBc Total Ab, w/Reflex, S | 16933-4 |
| HB_AB | HBs Antibody, S | 22322-2 |
| H_BAG | HBs Antigen, S | 5195-3 |
| HBSQN | HBs Antibody, Quantitative, S | 16935-9 |
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