Histoplasma Galactomannan Antigen Quantitative by EIA, Urine
Ordering Recommendation

Aid in the diagnosis of histoplasmosis. Recommend testing in conjunction with the combined complement fixation and immunodiffusion antibody (0050627) and serum antigen (0092522) tests.

Quantitative Enzyme Immunoassay
1-2 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
Random urine.  
Specimen Preparation
Transfer 2 mL urine to an ARUP Standard Transport Tube.  
Storage/Transport Temperature
Unacceptable Conditions
Specimens other than urine. Urine in boric acid. Serum; refer to test Histoplasma Antigen by EIA, Serum (ARUP test code 0092522).  
Ambient: Unacceptable; Refrigerated: 2 weeks; Frozen: 2 weeks (avoid repeated freeze/thaw cycles)  
Reference Interval
Not Detected
Interpretive Data
Less than 0.4 ng/ml=Not Detected
0.4-3.1 ng/mL=Detected (below the limit of quantification)
3.2-20.0 ng/mL=Detected
Greater than 20.0 ng/mL=Detected (above the limit of quantification)

The quantitative range of this assay is 3.2-20.0 ng/mL. Antigen concentrations between 0.4-3.1 or>20.0 ng/mL fall outside the linear range of the assay and cannot be accurately quantified.

This EIA test should be used in conjunction with other diagnostic procedures, including microbiological culture, histological examination of biopsy samples, and/or radiographic evidence, to aid in the diagnosis of histoplasmosis.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
CPT Code(s)
Component Test Code*Component Chart NameLOINC
2006111Histoplasma Galactomannan Ag Interp, Urn44524-7
2006112Histoplasma Galactomannan Ag Quant, Urn48952-6
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
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