COVID-19 Antigen Rapid Test Device
The COVID-19 antigen rapid test device instantly identifies the presence of the SARS-CoV-2 nucleoprotein in a swabbed nasal or nasopharyngeal specimen.
CLEARED FOR NASAL with an exeptionally high PPA (Positive Percentage Agreement) for a non-instrument test at 92.3%
The COVID-19 antigen rapid test device is a lateral flow in-vitro immunoassay intended to be used for the qualitative detection of the SARS-CoV-2 viral nucleoprotein. This device will detect both viable and nonviable virus in both nasopharyngeal and nasal secretions.
Result Interpretation
POSITIVE:
Two coloured bands appear on the membrane.
One band appears in the control region (C) and another band appears in the test region (T).
NEGATIVE:
Only one coloured band appears, in the control region (C).
One band appears in the control region (C) and another band appears in the test region (T).
INVALID:
Control band fails to appear.
Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
The colour intensity in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only and cannot determine the concentration of analytes in the specimen.
Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
This test is intended for professional use only and should not be used as the sole basis for the diagnosis of an infection.
Detection Window
Clinical Data
