Description
Lateral flow immunoassay intended for the qualitative detection of the antigenic nucleocapsid protein of the 2019-nCoV virus in saliva samples collected from patients with suspected COVID-19 infection in the first 7 days after the onset of symptoms.
The results refer to the identification of the antigenic protein of the nucleocapsid of the 2019-nCoV virus.
This reagent uses a sandwich of two antibodies to immobilize the new coronavirus (2019-nCoV) antigens in salivary samples.
During the test, the anti-2019-nCoV monoclonal antibody complex labeled with orocolloid and 2019-nCoV antigen migrates along the test strip and encounters the anti-2019-nCoV monoclonal antibodies immobilized in the T zone of the test, blocking migration and giving rise to a colored strip .
If the antigen is absent, the complex is not formed and the labeled antibody continues its migration without stopping, and no colored band is formed in the T-zone of the test.
Regardless of the presence of antigen in the sample, a colored band must always form in the control zone C.
A positive result indicates the presence of viral antigens but correlation with the patient's history and other diagnostic information is necessary to define the patient's infectious status. A positive result does not rule out co-infection with altriviruses. The agent detected by the test may not be the cause of the disease.
A negative result should be considered preliminary, does not rule out 2019-nCoV infection, and cannot be used as the sole basis for patient treatment, including infection control decisions. A negative result should be considered together with the patient's medical history, exposure and the presence of clinical symptoms consistent with COVID-19, and confirmed with molecular assays if necessary.
This test is intended for clinical laboratories or specifically trained medical personnel.

How to use
Sample collection and preparation
Insert the spongy part of the salivary swab into the mouth. Actively sample the inside of the mouth and tongue to collect oral fluid for at least 90 seconds. Stop sampling when the sponge is saturated and the indicator turns blue.
Do not drink or eat anything in the 4 hours prior to the test to avoid diluting the sample.
Process the collected sample as soon as possible.
Samples must not be deactivated.

During sampling, gently place the salivary swab and allow the saliva to be absorbed naturally by the sponge.
Do not squeeze the sponge with your tongue and do not bite the sponge with your teeth.
Any saliva sample is appropriate for testing but it is recommended that you sample in the morning before rinsing, eating or drinking.

Test procedure
Before performing the test, read the instructions carefully.
Take a card and allow it to equilibrate to room temperature. Remove the card from the foil pouch and place it on a flat surface. Insert the saliva swab into the card holder and press down. The tooth at the end of the swab must fit into the hole in the card. After attaching the salivary swab to the card, the test begins. You will see a purple band moving in the reading window, indicating that the sample is migrating onto the test strip.
Wait 15 minutes and read the result.
Do not read the result beyond 20 minutes.

Interpretation of the results
This device only provides a qualitative result of the tested sample.
- POSITIVE: if two colored bands appear within 15 minutes of applying the sample, one of them