PRODUCT DETAIL
MATERIALS PROVIDED
1. COVID-19 Saliva Ag Test Cassette
2. Instruction for use
3. Saliva collector
4. The extraction tube
5. Sample processing solution
6. Tube rack
SPECIMEN PREPARATION
Collect the saliva sample using the saliva collector and extraction tube provided. Do not place anything in the mouth including food, drink, gum, or tobacco products for at least 10 minutes prior to collection.
1. Insert the sponge of saliva collector into the mouth, actively swab the inside of the mouth and tongue to collect oral fluid for approximately 1-2 minutes until the sponge becomes soft and fully saturated.The sponge will be free from hard spots when fully saturated.
2. Unscrew the top of sample processing solution bottle.
3. Add 0.2mL (all solutions in the buffer bottle) of the sample processing solution into the extraction tube.
4. Squeeze the wall of the extraction tube against the sponge by hand, so that the saliva in the sponge of the saliva collector flows into the extraction tube, twist close the whole cap of saliva collector.
5. Gently shake the extraction tube vertically for about 5 seconds to allow saliva mix well with processing solution.
6. After 1 minute, the sample can be used for testing.
Note：
1. Sample size requirements: the correct sample size is within the dotted line, too little sample size or too much sample size is wrong.
2. Under normal temperature, samples should be processed within 1 hour after collection. If the sample cannot be tested in time after treatment, the processed sample should be refrigerated at 2-8 ℃ and the test should be completed within 12 hours after treatment.
3. Freezing and thawing of samples is strictly prohibited.
TEST PROCEDURE
1. Remove the test from the sealed pouch. Lay it on a flat, clean and dry surface.
2. Reverse the sample collection tube, and add 2-3 drops (about 75~100μL) of test sample by squeezing the collection solution tube into the sample well.
3. Read results within 10-15 minutes.
INTERPRETATION OF RESULTS
STORAGE AND STABILITY
Storage: store at 2~30℃.
Shelf life: 24 months.
PERFORMANCE CHARACTERISTICS
1. Analytical Sensitivity
The Coretests® COVID-19 Saliva Ag Test LOD was confirmed as 22.5 TCID50/mL.
2. Analytic Specificity
Results demonstrated that Coretests® COVID-19 Saliva Ag Test has no significant cross-reactivity with the seromarkers listed following：
3. Interference
The following substances and conditions were found not to interfere with the test. List of potentially interfering compounds and concentrations tested are as follows:
DIAGNOSTIC SENSITIVITY AND SPECIFICITY
A clinical study using a total 712 saliva samples was conducted.The results of the COVID-19 Saliva Ag Test were compared with a nucleic acid detection test . The diagnostic sensitivity and specificity of the test results are given as below:
Table 1 - Comparison of COVID-19 Saliva Ag Test Device
Results gave Sensitivity is 97.6% (161/165), specificity is 99.1%(542/547), and a total agreement of 98.7% (703/712).
