Histoplasma capsulatum Antibody Screen, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Evaluating persons with symptoms of respiratory disease, as an aid in the presumptive laboratory diagnosis of Histoplasma infection
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|
|SHSTO||Histoplasma Ab, S||Yes||No|
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
If result is equivocal or positive, SHSTO/26692 Histoplasma Antibody, Serum will be ordered at an additional charge.
HISTO/83853: Enzyme-Linked Immunosorbent Assay (ELISA)
SHSTO/26692: Complement Fixation (CF)/Immunodiffusion
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Histoplasma Ab Screen, S
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: 2 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
Histoplasma capsulatum is a soil saprophyte that grows well in soil enriched with bird droppings.
The usual disease is self-limited, affects the lungs, and is asymptomatic.
Chronic cavitary pulmonary disease, disseminated disease, and meningitis may occur and can be fatal, especially in young children and in immunosuppressed patients.
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.
Negative: Indicates antibodies to Histoplasma were not detected. The absence of antibodies is presumptive evidence that the patient was not infected with Histoplasma. However, the specimen may have been drawn before antibodies were detectable, or the patient may be immunosuppressed. If infection is suspected, another specimen should be drawn 7 to 14 days later and tested.
Equivocal: Specimens with equivocal EIA results will be tested by complement fixation and immunodiffusion.
Positive: The presence of antibodies is presumptive evidence that the patient was previously or is currently infected with (or exposed to) Histoplasma. These specimens will be tested by complement fixation and immunodiffusion for confirmation.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The use of this assay has not been established for screening the general population or for monitoring therapy.
The performance of this assay has not been established for ruling out diseases with similar symptoms eg, diseases caused by Mycobacterium tuberculosis, Coccidioides immitis, Aspergillus fumigatus, Blastomyces dermatitidis,Streptococcus pneumoniae, Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila or other pathogens.
The performance of this assay has not been established for matrices other than serum.
All results from this and other serologies must be correlated with clinical history, epidemiological data, and other data available to the attending physician in evaluating the patient.
The prevalence of infection will affect the assay’s predictive value.
The test can be positive with persons that are not currently infected with Histoplasma. Antibodies may be present because of a past infection.
The test can be negative with persons that are currently infected with Histoplasma. Specimens obtained very early in the infection may not have detectable antibodies.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Kaufman L, Kovacs JA, Reiss E: Clinical immunomycology. In Manual of Clinical Laboratory Immunology. 5th edition. Washington DC, ASP Press, 1997
Method Description Describes how the test is performed and provides a method-specific reference
Polystyrene microwells are coated with inactivated Histoplasma antigen. Diluted serum samples and controls are incubated in the wells to allow antihistoplasma antibodies (if present in the sample) to react with the antigen. Nonspecific reactants are removed by washing and peroxidase-conjugated anti-human antibody that reacts with human antibodies bound to the antigen is added. Excess conjugate is removed by washing. Enzyme substrate and chromogen are added, and the color is allowed to develop. After adding the stop reagent, the resultant color change is quantified by a spectrophotometric reading of optical density (OD). Sample OD readings are compared with reference cutoff OD readings to determine results. (Package insert: Histoplasma DxSelect, Focus Diagnostics, Cypress, CA)
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., Sunday; 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
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 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.
86698 x 3-Histoplasma antibody (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|
|HISTO||Histoplasma Ab Screen, S||44522-1|