Diphtheria Toxoid IgG Antibody Assay, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Determining a patient's immunological response to diphtheria toxoid vaccination
As an aid in the evaluation of immunodeficiency
Enzyme Immunoassay (EIA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Diphtheria Toxoid IgG Ab, S
Corynebacterium diphtheriae Antitoxin
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.
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.
Mild OK; Gross reject
Mild OK; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||14 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
In the United States, diphtheria toxoid is administered to children as part of the combined diphtheria-pertussis-tetanus vaccine. Anti-diphtheria toxoid antibodies form in response to vaccination using diphtheria toxoid protein.
This immunoassay, which uses the same protein (toxoid) that is used in the vaccine, provides a measurement of specific IgG antibodies produced in response to vaccination.
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.
The minimum level of protective antibody in the normal population is between 0.01 and 0.1 IU/mL. The majority of vaccinated individuals should demonstrate protective levels of antibody >0.1 IU/mL.
Results greater than or equal to 0.10 IU/mL suggest a vaccine response.
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 lack of protection/protection against diphtheria, or the presence or absence of immunodeficiency. Results must be confirmed by clinical findings and other serological tests.
At Mayo Clinic, anti-diphtheria toxoid IgG antibody levels were determined in the serum of 50 normal volunteers of unknown vaccination and immune status. The range was 0.106 to >9.0 IU/mL; 1 normal specimen was negative, with a value of 0.083 IU/mL.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Booy R, Aitken SJ, Taylor S, et al: Immunogenicity of combined diphtheria, tetanus, and pertussis vaccine given at 2, 3, and 4 months versus 3, 5, and 9 months of age. Lancet 1992;339(8792):507-510
2. Maple PA, Efstratiou A, George RC, et al: Diphtheria immunity in UK blood donors. Lancet 1995;345(8955):963-965
3. WHO meeting report: The Control of Diphtheria in Europe. WHO ref:EUR/ICP/EPI/024 1990
Method Description Describes how the test is performed and provides a method-specific reference
Microwells are precoated with diphtheria toxoid antigen. The calibrators, controls, and diluted patient specimens are added to the wells and antibodies recognizing the diphtheria toxoid 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 substrate that 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. (Package insert: Diphtheria Toxoid IgG Enzyme Immunoassay Kit, The Binding Site Ltd., Birmingham, England UK)
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; 3 p.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
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.
This test uses a reagent or kit labeled by the manufacturer as Research Use Only. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
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.
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|
|DIP||Diphtheria Toxoid IgG Ab, S||48654-8|