COVID-19 antigen test

Description
The CLUNGENE COVID-19 Antigen Test is a lateral flow immunoassay method for the qualitative detection of SARS CoV-2 nucleocapsid antigen in nasopharyngeal and oropharyngeal swabs of individuals suspected of being infected with COVID-19.

How to use
Sample collection with nasopharyngeal swab
1. Remove the swab from the packaging.
2. Tilt the patient's head back approximately 70 °.
3. Insert the swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equal to that from the ear to the patient's nostril, indicating contact with the nasopharynx. depth corresponding to the distance between the nostrils and the external opening of the ear). Gently rub and roll the tampon.Leave the tampon in place for a few seconds to absorb secretions.
4. Slowly remove the swab as you rotate it. Samples can be collected from both sides with the same swab. However, it is not necessary to collect samples from both sides when the mini-tip is saturated with liquid from the first collection. If a deviated septum or blockage causes difficulty in obtaining the sample from one nostril, use the same swab to obtain the sample from the other nostril.
Sample collection with nasal swab
1. Insert the swab approximately 2.5 cm into the nostril, rotating it slightly, until resistance is felt at the turbinates.
2. Turn the swab several times against the nasal wall and repeat the procedure in the other nostril with the same swab.
Sample collection with oropharyngeal swab
Insert the swab into the posterior pharyngeal and tonsillar area. Rub the swab on both tonsils and the posterior oropharynx and avoid touching the tongue, teeth and gums.
EXECUTION OF THE TEST
Note: Before testing, allow test devices, reagents, and samples to equilibrate to room temperature (15-30 ° C or 59-86 ° F).
- Place an extraction tube on the workstation.
- Add 0.3ml (10 drops) of Extraction Reagent into the extraction tube.
- For information on drawing the physical sample, see the "Examination" section.
Direct swab test method
1. Insert the sample with the swab into the extraction tube containing the extraction agent Roll the swab at least five times while pressing the head of the swab against the bottom and side of the extraction tube. Leave the swab in the extraction tube for one minute.
2. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. The extracted solution is used as a test sample.
3. Close the extraction tube tightly with the dropper tip.
4. Remove the test fixture from the sealed pouch.
5. Invert the specimen collection tube, hold the tube vertically, slowly add 3 drops into the specimen well (S) of the test fixture and start the timer.
6. Wait for the colored lines to appear. Read the test results after 15 minutes. After more than 20 minutes the results should be considered invalid.
Swabs in Viral Transport Media (VTM) Test Method
1. Insert the swab specimen into the transport tube containing a maximum of 3ml of VTM without denaturing agent.
2. Mix the stored sample by rotating it.
3. Transfer 300 fÊl of the sample containing the solution with a calibrated micropipet to the extraction tube containing the extraction reagent. Homogenize the mixture by pipetting up and down.
4. Firmly cover the extractor tube