Intended Use:

Test for detection of IgG/IgM antibodies to Leptospira organisms in human serum and plasma samples.

Introduction:

The clinical manifestations of leptospirosis range from a mild catarrh like illness to icteric disease with severe liver and kidney involvement. Natural reservoirs for leptospirosis include rodents as well as a large variety of domesticated mammals. The organisms occupy the lumen of nephritic tubules in their natural host and are shed in to the urine. Human infection derives from direct exposure to infected animals for e.g. (veterinarians, abattoir workers, or dairy workers) or by exposure to environment contaminated by animal carriers (e.g. agricultural workers). The organisms enter the host through skin abrasions, mucosal surfaces or the eye. The incubation period can range from 3 to 30 days but is usually found to be 10 to 12 days. Antibodies can become detectable by the 6th to 10th day of disease and generally reach peak levels within 3 to 4 weeks.