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Test ID: HIBS
Haemophilus influenzae Type B Antibody, IgG, Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

83261

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

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

 

As an aid in the evaluation of immunodeficiency

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

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 needed for testing

Serum

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.

Container/Tube: 

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 0.5 mL

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.

0.4 mL

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

NA

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 TypeTemperatureTime
SerumRefrigerated (preferred)7 days
 Frozen 7 days

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 young children including meningitis, bacteremia, cellulitis, epiglottitis, pneumonia, and septic arthritis.

 

One of the great advances in modern medicine has been the development of an effective vaccine against HIB. A patient's immunological response to HIB vaccine can be determined by measuring anti-HIB IgG antibody using this enzyme immunoassay (EIA) technique.

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

Interpretation Provides information to assist in interpretation of the test results

An anti-Haemophilus influenzae type B (HIB) IgG antibody concentration of 0.15 mg/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 mg/L postimmunization.(2) Furthermore, studies have shown that the response to HIB vaccine is age-related.

 

By testing pre- and postvaccination patient serum specimens, this test may be used to aid diagnosis of immunodeficiency.

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 Provides recommendations for further in-depth reading of a clinical nature

1. Berger M: Immunoglobulin G subclass determination in diagnosis and management of antibody deficiency syndromes. J Pediatr 1987;110(2):325-328

2. Peltola H, Kayhty H, Virtanen M, et al: Prevention of Haemophilus influenzae type B bacteremic infections with the capsular polysaccharide vaccine. N Engl J Med 1984;310(24):1561-1566

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

Microwells are precoated with the 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)

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.

Tuesday, Thursday; 9 a.m.

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.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

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 The location of the laboratory that performs the test

Rochester

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.

This test has been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

86684

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 IDReporting NameLOINC Code
83261Haemophilus influenzae B Ab, IgG, S11257-3