描述

Test procedure:
Carefully read the instructions prior to using the rapid test kit!
Perform the test no later than 30 minutes after taking the swab out of its packaging.
The test kit should be stored at a temperature between 10°C – 30°C, at a humidity level less than 70%.
According to the manufacturer, the test kit is valid for 12 months.

1. Take the swab out of its packaging.
   2. Hold the extraction tube in one hand or place it on a flat surface. Remove the cap by twisting it off. Add one whole extraction buffer package into the extraction tube.
   3. There are three possible methods for conducting the test.

Accuracy: Compared with the RT-PCR Assay, the probability of correct results by the rapid test kit, including both positive and negative patients.

Sensitivity: Compared with the RT-PCR Assay, among patients infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit.

Specificity: Compared with the RT-PCR Assay, among patients who have not been infected with SARS-CoV-2 virus, the probability of correct detection by the rapid test kit.

Nasopharyngeal swab (accuracy 99.35%, sensitivity, 98%, specificity 100%):

1. Slightly tilt the patient’s head back.
   2. Insert the swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. The swab should reach a depth equal to the distance from the nostrils to the outer opening of the ear.
   3. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions.
   4. Slowly remove the swab while rotating it between the fingers.

Nasal swab (from the nasal cavity) (accuracy 98,48%, sensitivity 96,80%, specificity 100%):

1. Gently insert the swab into the nostril, so that the tip of the swab reaches no more than 2,5 cm deep from the entrance of the nostril.
   2. Rotate the swab against the nasal wall to collect both the nasal mucus and cellular material.
   3. Slowly remove the swab while rotating it between the fingers.

Oropharyngeal swab (from the back of the throat):

1. Ask the patient to open the oral cavity as much as possible by making an “aah” sound. This will expose the tonsils.
   2. While inserting the swab, avoid contact with the tongue, teeth, cheeks or palate. After reaching the oropharynx, rub the swab on the posterior wall back and forth at least three times.
   3. Swirl the swab tip in the buffer fluid inside the extraction tube, pushing into the wall and bottom of the extraction tube at least three times. Then squeeze out the swab by squeezing the extraction tube with your fingers. Use the extracted fluid for the test.
   4. Cover the extraction tube tightly with the dropping nozzle cap. Take the test device out of its packaging. Hold the extraction tube vertically and squeeze three drops of fluid slowly into the specimen well of the test device (S). Start the timer.

Negative test results do not completely rule out the existence of SARS-CoV-2 particles in the sample!

Disposal:
Dispose of the test components inside a shatterproof, waterproof and tightly sealed container.