The coronavirus antigen rapid test kit is a lateral flow assay that qualitatively detects the presence of nucleocapsid (N) protein in upper respiratory samples (nasal swabs).
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
JOYSBIO is a ISO 13485 certified manufacturer, the following quality management systems are implemented to ensure the delivery of high-quality lateral flow rapid diagnostic test kits.
|EN ISO 13485:2016||EN ISO 18113-2:2011|
|EN ISO 14971:2012||EN ISO 23640:2016|
|EN ISO 15223-1:2016||EN 13975:2003|
|EN ISO 18113-1:2011||EN 13612:2002|