Manufacturing Companies for Test Kit For The Novel Coronavirus - COVID-19 Antigen Test Cassette (Nasal Swab Specimen) – TESTSEA

The 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.

How to collect the specimens?

Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield a falsely negative result; therefore, training in specimen collection is highly recommended due to the importance of specimen quality for generating accurate test results. Sample Collection

Nasopharyngeal Swab Sample Insert minitip 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.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.

2.Place the test device on a clean and level surface.

3.Unscrew the cap of the specimen buffer，push and rotate the swab with sample in the buffer tube. Rotate (twirl) swab shaft 10 times.

4.Hold the dropper vertically and transfer 3 drops of specimen solution (approximately 100μl) to the specimen well(S), then start the timer. See illustration below.

Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

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.