【INTENDED USE】

COVID-19 Antigen Rapid test (Saliva Test) is a lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in Saliva samples from individuals suspected of COVID-19.

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 other bacterial or viral infections.

Negative results from patients with symptom onset beyond seven days should be confirmed with a molecular assay. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management 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.

The product is intended to be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulations. For in vitro diagnostic use only.

【PRINCIPLE】

Covid-19 Antigen Rapid Test (Saliva Test) is based on colloidal gold immunochromatography assay. During the test, specimens and detection buffer are applied to the test cartridges. If there are SARS-CoV-2 nucleocapsid antigens in the specimens, they will bind to colloidal gold-labeled antibodies against SARS-CoV-2 N protein on conjugation pad forming virus antigen-antibody-colloidal gold complex (complex T).

During lateral flow, the complex T move along nitrocellulose membrane toward one end of the absorbent paper. When passing the line T (coated with another monoclonal antibody against virus N protein), the complex T is captured by capture antibody resulting in coloring on line T; when passing the line C, residual colloidal gold-labeled is captured by quality-control antibody resulting in coloring on line C.

[QUALITY CONTROL]

A procedural control is included in the test. A colored line appearing in the control region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

Control standards are not supplied with this kit. However, it is recommended that positive and negative controls be tested as good laboratory practice to confirm the test procedure and to verify proper test performance.

Perform the test

1. Deeply cough 3~5 times. Note: Please cover your mouth and nose with a mask or tissue paper and keep distance from other people.

2. Remove the cassette device from the sealed pouch and take the blue cap off gently by holding the sides to expose the collection pad.

3. Hold the device on the part opposite to the collection pad and place the collection pad into the mouth.

4.Rub the collection pad against the cheek and tongue gently in a circular motion 10 times. Then keep the collection pad in the mouth for about 1~2 minutes.

5.Check if the C line appears at the C region in the result reading window. If not, please repeat step 4 until a C line is visible or the total in-mouth time of the collection pad exceed 10 minutes.

6.Lay the device on a clean, flat surface with the result reading window upward and keep the collection pad untouched for 10-15 minutes. Please use a time device for timing.

7.Read the results between 10-15 minutes. Note: The result might be visible after a shorter time, however, it should only be interpreted between 10-15 minutes.