Description
It is an in vitro diagnostic device CE
It is a rapid immunochromatographic test for the qualitative detection of Strep A antigens in samples from pharyngeal swabs for the diagnosis of Group A Streptococcus infections.
When the sample is added into the appropriate cassette, by capillary migration the sample migrates through the membrane. When the levels of Group A Streptococcus antigen present in the sample are at or above the cut-off, a visible colored line appears in the test area, which indicates a positive result. The absence of such a colored line in the Test (T) zone suggests a negative result. If the test was performed correctly a colored line will appear on the control zone (C) as a procedural control.
