Histoplasma Galactomannan Antigen EIA, Serum

CPT: 87385
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Expected Turnaround Time

1 - 5 days



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Specimen Requirements


Specimen

Serum


Volume

2 mL


Minimum Volume

1 mL (Note: This volume allows for repeat testing.)


Container

Gel-barrier tube, red-top tube, or serum transfer tube


Collection

Collect specimen aseptically.


Storage Instructions

Maintain specimen at room temperature. Store alternatively at 2°C to 8°C.


Causes for Rejection

Insufficient specimen volume; inappropriate specimen source; inappropriate specimen collection device (ie, blood collected/submitted in an alternative blood collection tube); specimen stability exceeded; name discrepancy between the name on the specimen container and the name in the computer or on the requisition


Test Details


Use

Diagnosis of histoplasmosis based upon detection of antigen


Limitations

A negative result does not preclude a diagnosis of histoplasmosis. This assay has been documented to cross-react with Blastomyces dermatitidis, Coccidioides immitis, Paracoccidioides brasiliensis, and Penicillium marneffei. Positive tests should be confirmed in areas or patient groups where these organisms are endemic or a risk. The following substances may interfere with the assay results: caffeine; ascorbic acid; itraconazole; amphotericin B; acetaminophen; and acetylsalicylic acid.

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the Food and Drug Administration.


Methodology

Enzyme immunoassay (EIA)


Additional Information

Antigen detection may be useful in acute disease, especially in individuals also infected with HIV, who frequently have the disseminated form of histoplasmosis without detectable antibodies to the fungus. In chronic disease, antigen may not be detected due to the low fungal burden. The highest sensitivity for rapidly and accurately diagnosing histoplasmosis in patients with acute pulmonary or disseminated infection can be obtained by testing both urine and serum.


References

ALPHA Histoplasma EIA Test Kit for the Detection of Histoplasma Antigen- REF HAG102, Package Insert, Immuno- Mycologics, Inc., 2700 Technology Place, Norman, OK 73071, Revised 07/18/2011.
Connolly PA., Durkin MM, LeMonte AM, Hackett EJ, Wheat LJ. Detection of Histoplasma antigen by a quantitative enzyme immunoassay. Clin Vaccine Immunol. 2007 Dec;14(12):1587-1591. 17913863
Cox M, Pesek G, Phan D, Woods G. Utility of a Histoplasma capsulatum enzyme immunoassay for diagnosis of disseminated histoplasmosis and correlation with disease activity. Arch Pathol Lab Med. 2008. 132:1512.
Guarner J, Brandt ME. Histopathologic diagnosis of fungal infections in the 21st Century, Clin Microbiol Rev. 2011, Apr; 24(2):247-280.21482725
Guimaraes AJ, Nosanchuk JD, Zancope-Oliverira RM. Diagnosis of histoplasmosis. Braz J. Microbiol. 2006 Jan;37(1):1-13.20445761
Kauffman CA.. Histoplasmosis: A Clinical and Laboratory Update. Clinical Microbiology Reviews. 2007 Jan;20(1):115-132.17223625
Wheat LJ, Connolly-Stringfield PA, Baker RL, et al. Disseminated histoplasmosis in the acquired immune deficiency syndrome: clinical findings, diagnosis and treatment, and review of the literature. Medicine (Baltimore) 1990 Nov;69(6):361-374.2233233
Wheat LJ, Freifeld AG, Kleiman MB, et al. Clinical practice guidelines for the management of patients with histoplasmosis: 2007 update by the Infectious Diseases Society of America. Clin Infect Dis. 2007 Oct 1;45(7):807-825.17806045
Wheat LJ, Kohler RB, Tewari RP. Diagnosis of disseminated histoplasmosis by detection of Histoplasma capsulatum antigen in serum and urine specimens. N Engl J Med. 1986 Jan 9;314(2):83-88.3941695
Zhang X, Gibson B Jr, Daly TM. Evaluation of commercially available reagents for diagnosis of histoplasmosis infection in immunocompromised patients. J Clin Microbiol 2013 Dec;51(12):4095-4101.24088857

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
183512 Histoplasma Gal'mannan Ag Ser 51753-2 183515 Histoplasma Gal'mannan Ag Ser 44525-4
Reflex Table for Histoplasma Gal'mannan Ag Ser
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 183514 Histoplasma Gal'mannan Ag Qn S 183514 Histoplasma Gal'mannan Ag Qn S ng/mL 51753-2

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