Individual Package : Covid-19 (2019-nCoV) Antigen Rapid Test Cassette by Oral Fluid Saliva Collection

【BACKGROUND】

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.

【INTENDED USE】

The product is used for the qualitative detection of SARS-COV-2 infection. The entire detection process takes only 15-20 minutes, and the operation is simple and sensitive. No instrument required. It can be used for the screening of early infected patients and asymptomatic patients. This method is an effective supplement for nucleic acid detection.

【MAIN CONTENTS】

• Rapid Test Cassette.

• Specimen Collection Funnel.

• Preservation Solution Tube.

• Instructions for use.

【SAMPLE COLLECTION】

The oral fluid specimen should be collected by using the collection kit. No other collection devices should be used with this assay. Oral fluid collected at any time of the day may be used. Specimens should be tested as soon as possible after collection. If Oral Fluid is not to be processed immediately, it is stable for up to 8 hours at room temperature and 24 hours at 2-8°C.

【OPERATION PROCEDURE】

Allow the test cassette and specimen collection kit to equilibrate to room temperature (15-30°C) prior to testing.

Specimen Collection

Important:

Before collecting oral fluid, instruct the patients not to place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes prior to collection.

Instruct the patients to deeply cough 3-5 times to release sputum from deep throat to the mouth.

It is recommended to collect the first sputum after deep coughing in the morning.

① Use specimen collection kit to collect Approx. 2ml oral fluid specimen into 3ml preservation solution.

If there’s not enough oral fluid collected, repeat the above specimen collection steps.

Specimen Extraction

② Gently shake the mixture for 5 to 10 times.

NOTE: The storage of the specimen after extraction is stable for 2 hours at room temperature or 24 hours at 2-8°C.

Test Reaction

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.

③ Add Extracted specimen 3 drops (100µl) to the Test Device, Wait for the colored line(s) to appear.

Read the result at 15 minutes. Do not interpret the result after 20 minutes.

【PRECAUTIONS】

• For in vitro diagnostic use only.

• Do not use after expiration date.

• The test Cassette should remain in the sealed pouch until use.

• The used test Cassette should be discarded according to local regulations.