【Intended Use】
2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography) is an in vitro diagnostic rapid test for the qualitative detection of
2019-nCoV antigen (Ag) in human saliva specimens. The test is to be used as an aid in the diagnosis of coronavirus infection disease
(COVID-19), which is caused by 2019-now.The test provides preliminary test results. Negative results cannot exclude 2019-nCoV
infection and they cannot be used as the sole basis for treatment or other management decision.
For in vitro diagnostic use only. For professional use only
【Test Procedure】
Test Preparation
1. Allow all kit components to equilibrate to room temperature (15-30°C) prior to testing for 30 minutes.
2. Do not place anything in the mouth including food,drink,gum, tobacco,water and mouthwash products for at least 30 minutes prior
to collection of oral fluid specimen.
Specimen Collection & Extraction
1. Spit the expectorated saliva into the collection funnel gently as much as possible close to 1mL.
2. Unscrew the collection funnel gently to allow the saliva flow into the collection tube completely.
3. Screw the nozzle onto the collection tube.
4. Turn upside down the collection tube slightly for 5 seconds, so that the diluent can mix with the saliva sample evenly.
5. Leave the collection tube stand at room temperature for 5 minutes
6. Remove the nozzle cap.
Reaction with Test Cartridge
1. Remove a test cartridge from the sealed pouch by tearing at the notch and place it on a level surface.Drip 3~4 drops (about 100 μL) of
extracted specimens vertically into the specimen well (S) on the test cartridge by pressing the collection tube. Do not handle or move
the test cartridge until the test is complete and ready for reading. Bubbles that occur in the extraction tube can lead to inaccurate results.
2. Start timer. Read result within 15 ~20 minutes of adding the sample. The test result is invalid after 20 minutes.
