Shenzhen Oriental Beauty Equipment
Medical Equipment

97% Reliable Antigen SARS-CoV-2 Test Kit for home or office use

  • Model NO.: SARS-2
  • Standard:  CE + IVD
  • Min order:  20
  • Packed in  20 or 40 kit box
  • Accept Min order: Yes
  • Supply Ability: 2 Million  piece / Month
  • Country of Origin: Tianjing, China
  • Cash on delivery or 30 days.
  • Stock Time: 2 Days <500,000 - >1,000,000 7 days
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Description

JOYSBIO’s coronavirus Ag test kit was independently evaluated at Centro Diagnostico Delta S.r.l. in Italy. A total of 78 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 190 samples, the detection sensitivity is 98.72%, and the specificity is 97.32%.

  • Positive Percent Agreement (PPA) = 77/78(98.72%)(95%CI: 93.0%~100.0%)
  • Negative Percent Agreement (NPA) = 109/112(97.32%)(95%CI:92.4%~99.4%)
  • Accuracy = (77+109)/190×100% = 97.89%
  • Kappa = 2×(77×109-3×1)/(80 ×112+78 ×110) = 0.96>0.5

The limit of detection (LOD) of this product is 1.6 x 102 TCID50/mL, calculated through a gradient dilution method.

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