Test ID: HBIS
Hepatitis B Immune Status Profile, 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
Determining stage of disease, degree of infectivity, prognosis, and immune status of patients exposed to hepatitis B virus
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 |
| EAG | Hepatitis Be Ag, S | Yes | Yes |
| HEAB | HBe Antibody, 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
33189-HBIS
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: 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) | |
| Ambient | ||
| Refrigerated | ||
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Hepatitis B virus (HBV) is a DNA virus that 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 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. After a course of acute illness, HBV persists in approximately 10% of patients; some of these chronic carriers are asymptomatic.
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 Bs ANTIGEN
Negative
HEPATITIS Bc TOTAL ANTIBODY
Negative
HEPATITIS Be ANTIGEN
Negative
HEPATITIS Be ANTIBODY
Negative
HEPATITIS Bs ANTIBODY
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
In a normal course of hepatitis B virus (HBV) infection, hepatitis Be antigen (HBeAg) along with hepatitis B surface antigen (HBsAg) become detectable in a patient's serum during the incubation period, before the onset of clinical symptoms. Once clinical symptoms appear, HBeAg and HBsAg peak and then start to decline. The presence of HBeAg and/or HBsAg indicates active replication of HBV and positive results indicate patients are highly infectious for hepatitis B. HBV carriers usually carry HBsAg, and possibly HBeAg, indefinitely in the serum.
Hepatitis Be antibody (anti-HBe) begins to appear after HBeAg has disappeared and may be detectable for several years after a patient's recovery. Detectable anti-HBe in a patient who is an HBV carrier may indicate inactivity of the virus and low infectivity of the patient. However, the absence or disappearance of HBeAg or anti-HBe does not rule out chronic hepatitis B carrier state and/or infectivity.
Production of hepatitis B core antibody (anti-HBc) begins in the window period after HBsAg disappears and before anti-HBs appears. Anti-HBc is present shortly after the onset of symptoms and can remain present for years after HBV infection. Anti-HBc IgM is elevated during the acute phase of hepatitis B but will become negative within 6 months.
The presence of hepatitis B surface antibody (anti-HBs) usually indicates resolution of the HBV infection and acquired immunity to the virus. 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 results should be reported by the attending physician to the State Department of Health as required by law in some states.
Consider administration of hepatitis B immune globulin (HBIG) and hepatitis B vaccine to individuals exposed to the patient's blood and/or body fluids.
Performance characteristics have not been established for 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. Farrell G: Hepatitis B e antigen seroconversion: effects of lamivudine alone on in combination with interferon alpha. J Med Virol 2000 July; 61(3):374-379
3. Schiff ER: Lamivudine for hepatitis B in clinical practice. J Med Virol 2000 July;61(3):386-391
4. Sherlock S: Hepatitis B: the disease. Vaccine 1990;8 Suppl:S6-S9
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.
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, IgG & IgM
86706-Hepatitis Bs Ab, S
86707-Hepatitis Be Ab, S
87340-Hepatitis Bs Ag (HBsAg), S
87350-Hepatitis Be Ag (HBeAg), S
86705-Hepatitis Bc Ab, IgM (if appropriate)
87341- HBsAg confirmation (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 |
| EAG | Hepatitis Be Ag, S | In Process |
| HEAB | HBe Antibody, S | In Process |
| 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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