A lateral flow immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from human throat swabs specimen collected from symptomatic patients to aid in the diagnosis of Group A Streptococcal infection
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
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