Test ID: FHIME
Humoral Immunity Evaluation Panel
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.
Method Name A short description of the method used to perform the test
Enzyme Linked Immunosorbent Assay (ELISA)/Multi-Analyte Immunodetection (MAID)/Enzyme Immunoassay
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
Strep Pneumoniae 6 sero FORWARD
Tetanus Antitoxoid FORWARD
Diphtheria Antitoxoid FORWARD
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.
Draw blood in a plain red-top or serum gel tube. Spin down and send 4 mL serum refrigerated.
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 |
| Thawing | Warm OK; Cold OK |
| 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 | Refrigerated (preferred) | 14 days |
| Frozen | 30 days | |
| Ambient | 7 days |
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.
Humoral Immunity Evaluation
Diphtheria Antitoxoid
Reference Range: > or =0.01 IU/mL (Post-Vaccination)
Interpretive Criteria:
<0.01 IU/mL Nonprotective Antibody Level
> or =0.01 IU/mL Protective Antibody Level
This test was developed and its performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test.
Haemophilus influenzae Type B Antibody (IgG)
Reference Range: > or =1.00 mcg/mL post-vaccination (protective level)
Interpretive Criteria:
<0.15 mcg/mL Nonprotective Antibody Level
0.15 - 0.99 mcg/mL Indeterminate for protective antibody
> or =1.0 mcg/mL Protective Antibody Level
IgG antibody to polyribosylribitol phosphate (PRP), the capsular polysaccharide of Haemophilus influenzae type b, is measured in micrograms/mL (mcg/mL), based on correlations with a reference Farr radioimmunoprecipitation assay (RIA). The exact level of antibody needed for protection from infection has not been clarified; values ranging from 0.15 mcg/mL to 1.0 mcg/mL have been reported. A four-fold increase in the PRP IgG antibody level between pre-vaccination and post-vaccination sera is considered evidence of effective immunization.
Tetanus Antitoxoid
Reference Range: > or =0.50 IU/mL (Post-Vaccination)
Interpretive Criteria:
<0.05 IU/mL Nonprotective Antibody Level
0.05 - 0.49 IU/mL Indeterminate for Protective Antibody
> or =0.50 IU/mL Protective Antibody Level
Levels greater than or equal to 0.50 IU/mL are generally considered protective, whereas levels less than 0.05 IU/mL indicate a lack of protective antibody. Levels between 0.05 and 0.49 IU/mL are indeterminate for the presence of protective antibody and may indicate a need for further immunization to tetanus toxoid.
This test was developed and its performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test.
Streptococcus Pneumoniae IgG Ab (6 Serotypes), MAID
Serotype 1 (1) mcg/mL
Serotype 3 (3) mcg/mL
Serotype 14 (14) mcg/mL
Serotype 19 (19F) mcg/mL
Serotype 23 (23F) mcg/mL
Serotype 51 (7F) mcg/mL
Note: Serotype designations are American nomenclature, with Danish nomenclature in parentheses.
Studies from the 1980’s using radioimmunoassay suggested that vaccine-induced S. pneumoniae type-specific antibody levels of approximately 2.0 mcg/mL were protective against invasive pneumococcal disease. Newer methods (ELISA and multiplexed immunoassay) incorporating an adsorption step to remove cross-reactive antibodies yield results that are comparable to each other, but are lower than those obtained with the original radioimmunoassay. Rigorous studies of protective antibody levels as determined by the newer methods have not been performed. In addition to antibody quantity, protection also depends on antibody avidity and opsonophagocytic activity.
Evaluation of the response to pneumococcal vaccination is best accomplished by comparing pre-vaccination and post-vaccination antibody levels. A 2- to 4-fold increase in type-specific antibodies measured 4-6 weeks after vaccination is expected in immuno-competent adults. The number of serotypes for which a 2- to 4-fold increase is observed varies greatly among individuals; a consensus panel has suggested that individuals older than 5 years should respond to at least approximately 70% of pneumococcal serotypes. Adults >65 years old may exhibit a smaller (<2-fold) increase in type-specific antibody levels.
This test was developed and its performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test.
Test Performed by: Focus Diagnostics, Inc.
5785 Corporate Avenue
Cypress, CA 90630-4750
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; varies
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
Performing Laboratory Location The location of the laboratory that performs the test
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.
86648/diphtheria
86684/haemophilus influenza b
86317/x6 immunoassay for infectious agent Ab
86774/tetanus antitoxoid
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 |
|---|---|---|
| Z0688 | Diphtheria Antitoxoid | In Process |
| Z0689 | H. influenzae Type B IgG | In Process |
| Z0690 | Tetanus Antitoxoid | In Process |
| Z0463 | Serotype 1 (1) | In Process |
| Z0464 | Serotype 3 (3) | In Process |
| Z0465 | Serotype 14 (14) | In Process |
| Z0466 | Serotype 19 (19F) | In Process |
| Z0467 | Serotype 23 (23F) | In Process |
| Z0468 | Serotype 51 (7F) | In Process |
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