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SARS-CoV-2 Antigen Rapid Test

The SARS-COV-2 Antigen Rapid Test Device is a rapid visual
immunoassay for the qualitative, presumptive detection of COVID-19
antigens form throat swabs and nasopharyngeal swab specimens.
It is intended to be used by professionals as a test and provides a
preliminary test result to aid in the diagnosis of infection with novel
Any interpretation or use of this preliminary test result must also rely on
other clinical findings as well as on the professional judgment of health
care providers. Alternative test method(s) should be considered to confirm
the test result obtained by this test.
The SARS-COV-2 Antigen Rapid Test Device is a lateral flow
chromatographic immunoassay. The test strip in the cassette consists of:
1) a burgundy colored conjugate pad containing mouse anti-novel
coronavirus nucleoprotein monoclonal antibody conjugated with colloidal
gold and a control antibody conjugated with colloidal gold, 2) a
nitrocellulose membrane strip containing one test lines (T lines) and a
control line (C line). The T line is pre-coated with antibodies for the
detection of novel coronavirus nucleoprotein, and the C line is pre-coated
with a control line antibody.
When an adequate volume of test specimen is dispensed into the sample
well of the test cassette, the specimen migrates by capillary action along
the cassette. Novel coronavirus nucleoprotein, if present in the specimen,
will bind to the mouse anti-novel coronavirus nucleoprotein antigen
conjugates. The immunocomplex is then captured by the pre-coated
mouse anti-novel coronavirus nucleoprotein monoclonal antibody, forming
a burgundy colored T line, indicating an novel coronavirus positive test
result and suggesting an infection with novel coronavirus.
Absence of T lines suggests a negative result. Each test contains an
internal control (C line) which should exhibit a burgundy colored line of the
control antibodies regardless of color development on any of the test lines.
If the C line does not develop, the test result is invalid and the specimen
must be retested with another device.

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