COVID-19 ISO13485 Nasopharyngeal Antigen Swab Test

The COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens.

【SUMMARY】

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases.¹ Six coronavirus species are known to cause human disease.² Four viruses — 229E, OC43, NL63, and HKU1 — are prevalent and typically cause common cold symptoms in immunocompetent individuals.²

【SPECIMEN COLLECTION】

1. Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx.
2. Swab over the surface of the posterior nasopharynx.
3. Withdraw the sterile swab from the nasal cavity.

【SPECIMEN PREPARATION】
Only the extraction buffer and specimen collection tube provided in the kit is to be used for swab specimen preparation.
1. Unscrew the cap of the specimen collection tube.
2. Insert the swab specimen into the specimen collection tube. Press against the inner wall of the tube and stir the swab for approximately 10 seconds while pressing theswab head against the inner wall of the tube to release the antigens in the collection
tube.
3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
4. Tighten the cap onto the specimen collection tube.

【DIRECTIONS FOR USE】
Allow the test, extracted specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Invert the specimen collection tube and add 3 drops of the extracted specimen (approx.75μl) to the specimen well(S) and then start the timer.
3. Wait for the colored line(s) to appear. Read the result at 15 minutes. Do not interpret the result after 20 minutes.

【INTERPRETATION OF RESULTS】

POSITIVE:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the Test region (T). Positive result in the Test region indicates detection of COVID-19 antigens in the sample.
*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of COVID-19 antigen present in the sample. So any shade of color in the test region (T) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test line region (T).
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. If the problem persists, discontinue using
the test kit immediately and contact your local distributor.