BioSign Strep Aim Rapid Antigen Test

Principle of the test:

StrepAim is a rapid immunochromatographic assay for the qualitative detection of a group A streptococcal antigen directly from the throat swabs. Test involves the chemical extraction pf group A streptpcoccal antigen followed by Solid-based immunoassay techonology for the detection of extracted antigen. In this test procedure, a throat swab specimen is collected, placed into a mixture of Reagent A and B, and extracted for 1-2 minutes. The StrepAim* strip is then inserted into the tube containing the extract and the extract is allowed to migrate up to the test strip. If group A streptococci are present in the specimen, they will react with the conjugate dye and then react with the antibody in the Test line, to generate a colored Test line. The rest of the sample and dye continues to migrate to the control area, where antibody to the Strep A antibody is immobilized. In this area, the conjugate of anti-Strep A antibody and red dye react with anti-rabbit IgG antibody, to generate a red line. Presence of two colored lines, one Test line and one control line, indicates a positive result, while the absence of a Test line in the reading area indicates a negative result. In the absence of antigen in a sample, only the control line will develop.

The control line provides an additional quality control since it will only appear if: 1) The anti-strep A antibody on the colloidal gold is active; 2) The proper amount of sample is used; 3) The wicking chemistry is working properly. In the absence of the control line, the test should be considered invalid and should be repeated with a new strip and new swab sample.

For Research Use only. Not for use in diagnostic procedure.