Product Description
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
Direction Of Use/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.