JOYSBIO’s coronavirus Ag test kit was independently evaluated at Centro Diagnostico Delta S.r.l. in Italy between October 2020 and January 2021. A total of 107 positive specimens were tested with JOYSBIO’s COVID-19 Antigen Rapid Test Kit. These specimens were collected from patients who are suspected of COVID-19 with nasal swabs. The coronavirus antigen test kit’s sensitivity and specificity are compared against a CE-IVD marked RT-PCR test kit. This clinical evaluation is conducted under the assumption that SARS-CoV is no longer spreading in the community.
According to the clinical analysis of 492 samples, the detection sensitivity is 98.13%, and the specificity is 99.22%.
- Positive Percent Agreement (PPA) = 105/107 (98.13%) (95%CI: 93.4%~99.8%)
- Negative Percent Agreement (NPA) = 382/385 (99.22%) (95%CI:97.7%~99.8%)
- Accuracy = (105+382)/492×100%=98.98%
- Kappa = 2×(105×382-3×2)/(108×385+107 ×384) = 0.97>0.5
The limit of detection (LOD) of this product is 1.6 x 102 TCID50/mL, calculated through a gradient dilution method.