SARS-COV-2 AG Rapid Saliva Test Kits (Self-Testing)

TEST PROCEDURE

1. Clinical Performance
A clinical evaluation was carried out to confirm the sensitivity and specificity of the SARS-CoV-2 Ag Rapid Test Kit for SARS-CoV-2, compare results, and RT-PCR.

Clinical sensitivity (%)=[452/ (452+28)]×100%=94.2% (91.7%~95.9%);
Clinical specificity (%)= [ 700/ (O+ 700) ]×100%= 100%(99.5%~100%);
Total agreement rate (%)=[ (452+700)/ ( 452+ 28+0+ 780)]×100%= 97.1%(98.96%~100%).

2. Limit of Detection (LoD)
SARS-COV-2 nucleocapsid protein and spiker protein expressed in vitro were used for Limit of Detection (LoD) tests.
The LOD of the SARS-CoV-2 Ag Rapi Test Kit is 5 pg/mL SARS-COV-2 nucleocapsid protein.
The LOD of the SARSCoV-2 Ag Rapid Test Kit is 20 pg/mL SARS-CoV-2 spiker protein.