FDA Clears Test for Legionnaires' Disease

An enzyme-linked immunosorbent assay (ELISA) has been cleared by the U.S. Food and Drug Administration (FDA) as an adjunct to culture for the diagnosis of Legionnaires' Disease by qualitative detection of Legionella pneumophila serogroup 1 antigen in human urine. The test is called Legionella Urinary Antigen (LUA).

In a retrospective study on a panel of urine specimens from 94 culture-positive patients with L pneumophila serogroup 1, and 140 culture-negative individuals (including non-legionella pneumonia, bacteremia, pulmonary diseases, and urinary tract infections), LUA ELISA results and those of a commercial LUA ELISA were as follows: sensitivity (94.7% for the new test, 87.2% for the older test); specificity (89.3% for the new test, 83.6% for the older test); accuracy (91.4% for the new test, 85% for the older test). The test is the product of Bartels (Issaquah, WA, USA), a diagnostic and research reagents business that is a subsidiary of Intracel Corp.

"Another benefit of this new test is its rapid detection capabilities, with a total incubation time of 90 minutes,” noted Michael G. Hanna, Ph.D., chairman and chief scientific officer of Intracel. "In addition, it is very easy to use and it is flexible enough for both large and small testing facilities.”