Test Catalog

Test Id : HIBSG

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Haemophilus influenzae Type B Antibody, IgG, Serum

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Overview

Test Catalog

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

Assessing a patient's immunological (IgG) response to Haemophilus influenzae type B (HIB) vaccine

 

Assessing immunity against HIB

 

Aiding in the evaluation of immunodeficiency when the patient is tested pre- and post-vaccination

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

Haemophilus influenzae B Ab, IgG, S

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

H. influenzae Antibody

Haemophilus influenzae B Vaccine Response

HIB (Haemophilus influenzae Type B) Vaccine Response

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt 5 mL Aliquot Tube (T914)

Container/Tube: 

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

Forms

If not ordering electronically, complete, print, and send Infectious Disease Serology Test Request (T916) with the specimen.

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

0.4 mL

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

Gross hemolysis Reject
Gross lipemia Reject
Heat-inactivated 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 Refrigerated (preferred) 7 days
Frozen 7 days

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

Assessing a patient's immunological (IgG) response to Haemophilus influenzae type B (HIB) vaccine

 

Assessing immunity against HIB

 

Aiding in the evaluation of immunodeficiency when the patient is tested pre- and post-vaccination

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

Haemophilus influenzae type B (HIB) is an encapsulated Gram-negative cocco-bacillary bacterium that can cause devastating disease in unvaccinated young children, including meningitis, bacteremia, cellulitis, epiglottitis, pneumonia, and septic arthritis. The outer surface of H influenzae is covered by a polyribosyl-ribitol-phosphate (PRP) polysaccharide that is responsible for both pathogenicity and immunity. There are currently 6 recognized PRP serotypes, referred to as a through f, among which serotype b, prior to the availability of a vaccine, accounted for up to 95% of infections. There are also unencapsulated or nontypable strains.

 

Prior infection with H influenzae is associated with protective immunity against reinfection. One of the great advances in modern medicine has been the development of an effective vaccine against HIB, which is based on use of an unconjugated, purified PRP antigen. A patient's immunological response to HIB vaccine can be determined by measuring anti-HIB IgG antibody levels using a standardized enzyme immunoassay (EIA). Antibody levels of1 mcg/mL or more at least 3 weeks after vaccination has been correlated with long-term protective immunity.

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.

> or =0.15 mg/L

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

An anti-Haemophilus influenzae type B (HIB) IgG antibody concentration of 0.15 mcg/L is generally accepted as the minimum level for protection at a given time; however, it does not confer long-term protection. A study from Finland suggested that the optimum protective level is 1.0 mcg/L postimmunization.(1) Furthermore, studies have shown that the response to HIB vaccine is age-related.

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

This assay does not provide diagnostic proof of the presence or absence of immune deficiency. Results must be confirmed by clinical findings and other laboratory tests.

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

1. Peltola H, Kayhty H, Virtanen M, Makela PH l: Prevention of Haemophilus influenzae type B bacteremic infections with the capsular polysaccharide vaccine. N Engl J Med. 1984;310(24):1561-1566. doi: 10.1056/NEJM198406143102404

2. Berger M: Immunoglobulin G subclass determination in diagnosis and management of antibody deficiency syndromes. J Pediatr. 1987;110(2):325-328. doi: 10.1016/s0022-3476(87)80182-8. 

3. Murphy TF: Haemophilus species, including H influenzae and H ducreyi (Chancroid). In: Bennett JE, Dolin R, Blaser MJ, eds. Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Elsevier; 2020:2743-2752

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

Microwells are precoated with the Haemophilus influenzae type B (HIB) capsular polysaccharide antigen conjugated to human serum albumin. The calibrators, controls, and diluted patient specimens are added to the wells and antibodies recognizing the HIB antigen bind during the first incubation. After washing the wells to remove all unbound proteins, purified peroxidase-labeled rabbit antihuman IgG (gamma chain specific) conjugate is added. The conjugate binds to the captured human antibody and the excess unbound conjugate is removed by a further wash step. The bound conjugate is visualized with 3,3',5,5' tetramethylbenzidine (TMB) substrate, which gives a blue reaction product, the intensity of which is proportional to the concentration of antibody in the specimen. Phosphoric acid is added to each well to stop the reaction. This produces a yellow end point color, which is read at 450 nm.(Madore DV, Anderson P, Baxter BD, et al: Interlaboratory study evaluating quantitation of antibodies to Haemophilus influenzae type B polysaccharide by enzyme-linked immunosorbent assay. Clin Diagn Lab Immunol. 1996;3[1]:84-88. doi: 10.1128/cdli.3.1.84-88.1996.; Bennett JE, Dolin R, Blaser MJ, eds: Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. 9th ed. Elsevier; 2020)

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, Friday

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 6 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

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.

86684

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
HIBSG Haemophilus influenzae B Ab, IgG, S 11257-3
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.
HIBSG Haemophilus influenzae B Ab, IgG, S 11257-3

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

Test Update Resources

Change Type Effective Date
New Test 2021-09-28