Quantitative Enzyme Immunoassay
Transfer 2 mL urine to an ARUP Standard Transport Tube.
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)
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.
|Component Test Code*||Component Chart Name||LOINC|
|2006111||Histoplasma Galactomannan Ag Interp, Urn||44524-7|
|2006112||Histoplasma Galactomannan Ag Quant, Urn||48952-6|
- Histoplasma capsulatum