L.pneumophila Antigen Rapid Test (DTS593)

Regulatory status: For research use only, not for use in diagnostic procedures.

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Intended Use
Anin vitro rapid immunochromatographic assay for the qualitative detection of Legionella pneumophila serogroup 1 antigen (L. pneumophilaserogroup 1 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. pneumophilaserogroup 1 in conjunction with culture and other methods.
Store as packaged in the sealed pack either at refrigerated or room temperature (2-30°C/36-86°F). The test and reagents are stable until the expiration date printed on their packaging and external kit.
The Legionella pneumophila Device was highly sensitive (>99%) compared with the results of the Binax NOW? Legionella
Urinary Antigen Test.


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