FIATEST COVID-19 Antigen Test (Test with Flurescence Immunoassay Analyzer)

The COVID-19 Antigen Test is a test for measuring COVID-19 antigens in Nasopharyngeal Swab specimens with the use of Fluorescence Immunoassay Analyzer.

【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】
Refer to FIATESTTM Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions on use of the Test. The test should be conducted in room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “standard test” or “Quick test” mode.
2. Take out the ID card and insert it into the Analyzer ID Card Slot.
3. Add 3 drops of the solution (approx.120ul) to the sample well and then start the timer.
4. After 15 minutes of adding sample, Insert the test cassette into the Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST" immediately. The Analyzer will automatically give the test result after a few seconds.

【INTERPRETATION OF RESULTS】

Results read by the Fluorescence Immunoassay Analyzer and display the result on the screen.