20 x PCR Rapid Test Covid-19 Saliva Tests

Pack of 20 PCR Covid-19 Saliva Tests

The Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset and is 96% accurate.

Results are given for the identification of 2019-nCoV nucleocapsid protein antigen. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Negative results should be treated as presumptive, and do not rule out 2019-nCoV infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.

PRINCIPLE OF THE TEST

This Card uses a double-antibody sandwich to detect the antigen presence of novel coronavirus (2019-nCoV) in saliva samples.

During detection, the gold labelled anti-2019-nCoV monoclonal antibody in the labelling pad binds to the 2019-nCoV antigen in the sample to form a complex.

The reaction complex moves along the nitrocellulose membrane under the action of chromatography.

It is then captured by the anti-2019-nCoV monoclonal antibody pre-coated in the detection zone (T) on the nitrocellulose membrane, and finally a red colour reaction line is formed in the T zone.

If the sample does not contain 2019-nCoV antigen, a red colour reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the quality control area (C).