Novel Coronavirus (COVID-19) Antigen Detection Kit
•An alternative diagnostic method for Novel Coronavirus (COVID-19); faster and easier to implement than PCR.
•High specificity and high sensitivity
•The FDA has granted EUA for antigen tests that can identify COVID-19; it is used in Korea, USA, Colombia at the community level, outpatient clinics, hospitals, occupational medicine, etc.
•Gene Science's antigen tests have a buffer that inactivates the virus so can be used without a biosafety cabinet.
•WHO Recommended the antigen tests 
Product Information
The coronavirus disease 2019 (2019-nCoV) Antigen Detection Reagent is an in vitro test card for the determination of novel coronavirus in nasopharyngeal (NP) swab or saliva samples. This kit achieves the purpose of detection by combining the coronavirus disease 2019 (2019-nCoV) antigen and the coronavirus disease 2019 (2019-nCoV) antibody to form a reaction complex for color rendering. This product can quickly and accurately diagnose the coronavirus disease 2019 (2019-nCoV) ) .
•15-20 minutes to get the test results.
•The operation is simpler and faster, and the samples are easy to store.
•No other reagents are needed for the test
•High sensitivity and high accuracy.
Positive reference for QC: use three positive corporate reference materials (P1-P3) for testing, and the result should be positive.
Negative references for QC: Three types of negative reference materials (N1-N3) have been tested, and the results should be negative.
Minimum detection limit: three corporate sensitivity reference materials (L 1, L2, L3) are used for testing, and each sample is repeated 3 times. The L1 test results should all be positive, and the L2 and L3 test results should both be negative.
Repeatability: Tested the repeatability of three reference products. Each test is repeated 10 times and should be positive.
Sensitivity: 92.11% (35/38, 95% CI, 78.62% - 98.34%)
Specificity: 100.00% (50/50, 95% CI, 92.89% - 100.00%)

Interpretation of Results


It has been recorded in EU COVID-19 In Vitro Diagnostic Devices and Test Methods Database.

COVID-19 In Vitro Diagnostic Devices and Test Methods Database
It's also been recorded in EU HSC Common List.

EU HSC Common List
It is endorsed by WHO FIND.

Here is the CE certification.