【INTENDED USE】

Testsealabs®COVID-19 Antigen Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of COVID-19 antigen in nasal swab specimen to aid in the diagnosis of COVID-19 viral infection.  

【Specification】

25pc/box (25 test devices+ 25 Extraction Tubes+25 Extraction Buffer+ 25 Sterilized Swabs+1 Product Insert)

【MATERIALS PROVIDED】

1.Test Devices
2.Extraction Buffer
3.Extraction Tube
4.Sterilized Swab
5.Work Station
6.Package Insert

【SPECIMENS COLLECTION】

Insert mini tip swab with a flexible shaft (wire or plastic) 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. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated with fluid from the first collection. If a deviated septum or blockage creates difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.

【HOW TO TEST】

Allow the test, specimen, buffer and/or controls to reach room temperature 15-30℃ (59-86℉) prior to testing.

1.Place the Extraction Tube in the workstation. Hold the extraction reagent bottle upside down 

vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add 10 drops of solution to the Extraction Tube.

2.Place the swab specimen in the Extraction Tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.

3. Remove the swab while squeezing the swab head against the inside of the Extraction Tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol.

4.Cover the tube with cap,then add 3 drops of the sample into the sample hole vertically.

5.Read the result after 15 minutes. If left unread for 20 minutes or more the results are invalid and a repeat test is recommended.

【INTERPRETATION OF RESULTS】

Positive: Two lines appear. One line should always appear in the control line region(C), and another one apparent colored line should appear in the test line region.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of COVID-19 antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

Negative: One colored line appears in the control region(C).No apparent colored line appear in the test line region.

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

【INTERPRETATION OF RESULTS】

Positive: Two lines appear. One line should always appear in the control line region(C), and another one apparent colored line should appear in the test line region.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of COVID-19 antibodies present in the specimen. Therefore, any shade of color in the test line region should be considered positive.

Negative: One colored line appears in the control region(C).No apparent colored line appear in the test line region.