Singclean IVD Antigen Test Kit Colloidal Gold Method 1pc

The Singclean® Rapid Diagnostic Test is an immunochromatographic assay kit for the qualitative detection of antigens of the new SARS-CoV-2 coronavirus in a nasal, pharyngeal or nasopharyngeal swab from a human sample.

Used for rapid assay of SARS-CoV-2 virus. Virus antigens present in the test sample will react with monoclonal antibodies (mAb) against the SARS-CoV-2 virus, conjugated to gold nanoparticles placed in the matrix of the test apparatus as well as monoclonal antibodies (mAb) against the virus. SARS-CoV-2 mounted on the test cassette.

When the test sample contains SARS-CoV-2 virus antigens, a visible line appears on the membrane in the test cassette. The solution continues to move to react with a control reagent, which binds a complex control solution (control conjugate), thus producing another visible line on the membrane, in the control region (C).

Interpretation of results:

Negative result: ONLY one zone is colored, on the control line [C]
Positive result: Color appears in two zones, on the test line [T] and on the control line [C]
Invalid result: If the control line [C] (Control line) does not appear after 20 minutes, the result is considered invalid regardless of whether a strip of any color appears in the test line [T]. In this case a new test should be performed, collecting a new sample from the patient and using a new test device.