10 individually packed test cassettes for detection of Legionella pneumophila (L. pneumophila) serogroup 1 antigen in urine specimens from patients with symptoms of pneumonia.
Package contents:
10 test cassettes
1 Positive control
1 Negative control
1 package insert
Exclusively for professional users
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The NADAL® Legionella Test is an in-vitro rapid chromatographic lateral flow immunoassay for the qualitative detection of Legionella pneumophila (L. pneumophila) serogroup 1 antigen in urine specimens from patients with symptoms of pneumonia. The NADAL® Legionella Test is intended to be used in conjunction with culture and other methods as an aid in the presumptive diagnosis of Legionella infection (Legionnaires’ disease) caused by L. pneumophila serogroup 1.
Legionnaires’ disease is a serious form of pneumonia accompanied by a mortality rate in the range of 10-15% in otherwise healthy individuals. The symptoms are similar to those of a flu-like illness followed by a dry cough, and frequently progress to the symptoms of pneumonia. Approximately 30% of people infected may also develop diarrhoea and vomiting and around 50% may show signs of mental confusion. The incubation period normally ranges from 2-10 days, with symptoms typically being displayed from 3-6 days after exposure. Legionnaires’ disease may occur as an outbreak of two or more cases following a limited temporal and spatial exposure to a single source. It may also appear as a series of independent cases in an area in which it is highly endemic. Moreover, Legionnaires’ disease may occur as sporadic cases without any obvious temporal or geographical grouping. Outbreaks have occurred repeatedly in establishments such as hotels and hospitals.
The NADAL® Legionella Test allows an early diagnosis of L. pneumophila serogroup 1 infection through detection of a specific soluble antigen present in the urine of patients with Legionnaires’ disease. The L. pneumophila serogroup 1 antigen has been detected in urine as early as three days after the onset of symptoms. The test is rapid, giving a result within 15 minutes, and is carried out using urine specimens which allow convenient collection, transportation and subsequent detection of the early as well as late stages of the disease.