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Results are provided at 15 minutes. 20 Tests per Box.
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In June 2020, JOYSBIO Biotechnology proudly released a new COVID-19 Antigen Rapid Test Kit (Colloidal Gold). The new coronavirus antigen test kit is a lateral flow immunoassay for the qualitative detection of SARS-COV-2 antigen (nucleocapsid protein) in upper respiratory samples with nasal swabs or saliva during the acute phase of infection.
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.
***Due to FDA Guidelines and Supply Chain Demands All Orders for this Product are NON-Cancellable and NON-Returnable!