Wuxi Owgels Medical Instruments Co., Ltd
Wuxi Owgels Medical Instruments Co., Ltd
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CE approved Rapid Diagnostic Test Kit Antigen Fast Diagnostic Throat Test kits Nasal Swab Fast Test
Overall Clinical Performance of Antigen Test Kit
A total of above 157 positive samples and 260 negative samples were detected to evaluate the clinical performance of the COVID-19 Antigen Rapid Test Kit. The Result is below:
| Sansure Covid-19 RT-PCR Assay | ||||
| Positive | Negative | Total | ||
| Kewei COVID-19 Antigen Rapid Assay | Positive | 143 | 0 | 143 |
| Negative | 14 | 260 | 274 | |
| Total | 157 | 260 | 417 | |
The assay demonstrated acceptable total clinical sensitivity is 91.08% (95% CI: 85.59%-94.61%) when compared to a molecular device produced by Sansure Inc. The assay demonstrated excellent clinical specificity 100% (95% CI: 98.54%-100%). Overall Agreement was 96.64% (94.44%-97.99%).
Limit of Detection(LoD)
Limit of detection (LoD) was determined by evaluating different concentrations of heat inactivated SARS-CoV-2 virus. LoD of the SARS-CoV-2 antigen rapid kit was confirmed as 38.5 TCID50/ml.
