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Physicians who suspect patient symptoms to be a result of mold exposure may wish to recommend and review reports of mold testing. Spore°Tech Mold Investigations, LLC, Louisville KY (502-262-2022) conducts mold inspections and testing for Aspergillus and other molds believed to cause invasive fungal infections or allergenic symptoms.

FDA Clears Rapid Test for Aspergillus Infection

The Food and Drug Administration (FDA) today (May 16, 2003) cleared for marketing the first rapid laboratory test for a life-threatening invasive fungal infection that occurs in leukemia patients, organ and bone marrow transplant patients, and patients whose immune systems are compromised by illness or chemotherapy. The test will allow doctors to diagnose invasive aspergillus infection quicker and begin treatment with anti-fungal drugs sooner.

The new test, the Platelia Aspergillus EIA, manufactured by Bio-Rad Laboratories, of Redmond, Wash., detects Aspergillus galactomannan antigen in blood, and is a good indicator of invasive infection. Results are available in about three hours. By comparison, the standard culture method of testing for aspergillus takes a minimum of four weeks before results are available.

'Earlier detection means earlier and more accurate intervention with life-saving treatment for these critically ill patients, said FDA Commissioner Mark B. McClellan, M.D., Ph.D. One of FDA's goals is to help make new products that improve medical care available to the public as quickly as possible. FDA cleared the product based on clinical studies of the test's performance at three cancer centers that showed the test could accurately identify the presence or absence of the aspergillus antigen.

The centers tested 1,890 blood samples collected from 170 patients. Thirty one patients had proven or probable invasive aspergillosis. The new test correctly identified 25 of the 31 people who had aspergillus antigen (80.7% sensitivity). When 148 patients without signs or symptoms of invasive aspergillosis were tested, the test correctly identified 132 of the 148 (89.2% specificity) as not having the antigen.

Although the number of invasive aspergillus cases in the United States is estimated to be only a few thousand per year, the disease is very serious and has a mortality rate of 50%-100%

Source: FDA NEWS 5/16/03 http://www.fda.gov

Spore°Tech Mold Investigations, LLC, Louisville, KY, conducts mold inspections that include bioaerosol and spore trap collection methods for the sampling of viable and non-viable mold spores in indoor air. Outdoor environmental air testing is conducted to offer benchmark data and comparative analysis to indoor air mold sampling results. Healthcare professionals wishing to discuss the details and techniques of our mold inspection, mold testing and sampling services can contact Spore°Tech Mold Investigations, LLC, Louisville, KY at 502.262.2022 or e-mail inquires to info@spore-tech.com

 

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