Histoplasma Galactomannan Antigen Quantitative by EIA, Urine


Abbrev Code:HISTOGMU   
Order Code:LAB1052Order Name:Histoplasma Galactomannan Antigen Quant by EIA, Urine
Synonyms:Histoplasma capsulatum
Methodology:Quantitative enzyme immunoassay
CPT Codes: 87385 x1, 87385 x1, 87385 x1
Turnaround Time:Specimens are sent to the reference laboratory Mon-Sun; results are reported within 1-2 days.
Compliance:

This test uses a manufacturer labeled Analyte Specific Reagent (ASR) as the reagent providing the specificity of the assay. The test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.


Collection Instructions

Specimen:Urine
Optimal Volume:10 mL
Minimum\Peds Volume:2 mL
Container:Plastic leakproof container, sterile
Collection Instructions:Submit specimen on ice.
Causes for Rejection:Specimens other than urine. Urine in boric acid.


Processing and Shipping

Specimen Processing:Transfer 2 mL to an ARUP transfer tube. Refrigerate immediately.
Shipping Instructions:Ship at refrigerated temperature.
Stability:2 weeks refrigerated; 1 month frozen
Test Performed at or Referral Lab Lab Sendouts  (ARUP)
Referral Lab number:2009418


Interpretive

Reference Range:
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 ng/mL or greater than 20.0 ng/mL fall outside the linear range of the assay, and cannot be accurately quantified.
Use:Aids in the diagnosis of histoplasmosis. Recommend testing in conjunction with Histoplasma Antbodies by CF & ID and Histoplasma Antigen Quantitative by EIA, Serum. This EIA test should be used in conjunction with other diagnostic procedures, including microbiological culture, histological examination of biopsy sample, and/or radiographic evidence.


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