COVID-19 Antigen Saliva Test Kit (Oral )
(Colloidal Gold)
 

Please read all the information in the leaflet before performing the test.

Intended Use

COVID-19 Ag Rapid Saliva Test Device is a rapid chromatographic immunoassay for the qualitative detection of N antigen from SARS-CoV-2 present in human saliva within the first 7 days of symptom onset. This test is for professional used only, as an aid to early diagnosis of SARS-CoV-2 infection in patient.

The result of this test should not be the sole basis for the diagnosis; confirmatory testing is required.

Kit Content

1. Test device (individually packed in a foil pouch with desiccant).
2. Instruction for use.

Materials required but not provided

Timer      

Test Procedure

The COVID-19 Ag Rapid Saliva Test Device is designed for one-step test for COVID-19 antigen in human saliva..

Allow the test device to reach room temperature 15~30°C, and instruct the user not to eat, drink, smoke or chew tobacco products for at least 10 minutes prior to use the test.

1. Remove the test device from the sealed pouch and use the device as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2. Cough deeply twice before collecting the samples.
3. Pull the blue cap off gently by holding the sides to expose the collection pad.
4. Hold the top portion of the device and place the collection pad into the mouth.
5. Rub the collection pad against the cheek and tongue gently in a circular motion about 10 times. And then place the collection pad in the mouth for about 1~2 minutes until the C line show up in the C region.
6. Remove the device from mouth as soon as the C line appears at the C rigion.
7. Place the cap onto the device, lay it on a flat surface.
8. Read results at 10~15minutes after removing device from mouth.  Do not read results after 20 minutes.

                                                                                          Fig. A  Gently rub the collection pad against each cheek several times.

                                   Fig B.  Gently rub the collection pad on top of the tongue.                                         Fig C.  Place the collection pad underneath the tongue.

Interpretation of Results

NEGATIVE:

Only one red band appears in the control region (C), and no band in the test region (T). The negative result indicates that there are no Novel coronavirus antigen in the sample or the number of viral particles is below the detectable range.

POSITIVE:

Two red bands appear. One red band appears in the control region (C), and one red band in the test region (T).

The shade of color may vary，but it should be considered positive whenever there is even a faint band.

INVALID:

No red band appears in the control region (C). The test is invalid even if there is a band on test region (T). Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the test procedure and repeat the test using a new test device.

Do not interpret the result after 20 minutes.