1. This package insert must be read completely before performing the test. Failure to follow directions in package insert may yield inaccurate test results.
2. For professional in vitro diagnostic use only. Do not use after expiration date.
3. Do not eat, drink or smoke in the area where the specimens or kits are handled.
4. Do not use test if pouch is damaged.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout in the collection, handling, storage, and disposal of patient samples and used kit contents.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Wash hands thoroughly after handling.
8. Please ensure that an appropriate amount of samples are used for testing. Too much or too little sample size may lead to deviation of results.
9. Sterile Swabs for the collection of Nasopharyngeal specimen and Nasal specimen are different, Do not mix the using of the two types of sampling swabs.
10.Viral Transport Media (VTM) may affect the test result; extracted specimens for PCR tests cannot be used for the test.
11.The used test should be discarded according to local regulations.
12.Humidity and temperature can adversely affect results.
SPECIMEN COLLECTION, TRANSPORT AND STORAGE
Nasopharyngeal Swab 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.
Nasal Swab Specimen Collection
1. Insert a sterile swab less than one inch (about 2 cm) into a nostril (until resistance is met at the turbinates).
2. Rotate the swab 5-10 times against the nasal wall. Using the same swab repeat the collection procedure with the second nostril.
3. Withdraw the sterile swab, avoid excess volume and high-viscous nasal discharge.
Caution:
If the swab stick breaks during specimen collection, repeat specimen collection with a new swab.
Specimen transport and storage
Specimens should be tested as soon as possible after collection. If swabs are not been processed immediately, it is highly recommended the swab sample is placed into a dry, sterile, and tightly sealed plastic tube for storage. The swab specimen in dry and sterile condition is stable for up to 24 hours at 2-8°C.
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 extraction tube and add 3 drops of extracted specimen (approx.75-100μl) 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.
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 SARS-CoV-2 antigens in the sample.
*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of SARS-CoV-2 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.
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.
