Rapid test for Aspergillus infection

FDA Consumer, July-August, 2003

A new test will allow doctors to diagnose a potentially life-threatening fungal infection sooner. Invasive aspergillosis infections occur in people with leukemia, people who have received organ and bone marrow transplants, and in people whose immune systems are compromised by illness or chemotherapy. Although the number of invasive aspergillosis cases is estimated to be only a few thousand per year, the disease is very serious and has a mortality rate of between 50 percent and 100 percent.

The FDA cleared the test, Platelia Aspergillus EIA, in May. The test detects Aspergillus galactomannan antigen in blood, and results are available in about three hours. By comparison, it takes at least four weeks before results are available with the standard culture method of testing for Aspergillus.

Clinical studies at three cancer centers showed the test could accurately identify the presence or absence of the Aspergillus antigen. The centers tested 1,890 blood samples collected from 170 ,people. Thirty-one patients had proven or probable cases of invasive aspergillosis. The new test correctly identified 25 of the 31 people who had Aspergillus antigen. When 148 people without symptoms were tested, the test correctly identified 132 of the 148 as not having the antigen.

The Platelia Aspergillus EIA test is manufactured by Bio-Rad Laboratories of Hercules, Calif.