Legionella Pneumophila Antigen Rapid Test

【INTENDED USE】

The Legionella Pneumophila Antigen Rapid Test Cassette (Urine) is an in vitro rapid  immunochromatographic assay for the qualitative detection of Legionella pneumophila  antigen in urine specimens from patients with symptoms of pneumonia. It is intended to aid in  the presumptive diagnosis of Legionella infection (Legionnaires’ disease) caused by L.  pneumophila in conjunction with culture and other methods.

【DIRECTIONS FOR USE】

Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15- 30°C) prior to testing.  1. Bring the pouch to room temperature before opening it. Remove the test cassette from the  sealed pouch and use it as soon as possible. Best results will be obtained if the assay is  performed within one hour.  2. Place the test cassette on a clean and level surface. Hold the dropper vertically and  transfer 3 drops of sample (approximately 120 L) to the specimen well of the test  cassette and start the timer. Avoid trapping air bubbles in the specimen well. See the  illustration below.  3. Wait for the colored line(s) to appear. The test result should be read at 15 minutes. Do not  interpret the result after 20 minutes.