| Supply Ability | 1million per week |
| Delivery Time | 3-5working days |
| Packaging Details | 25pcs per case |
| Sample Type | Nasal/Throat Swab |
| Overall Agreement | 97.5% |
| Certificate | CE |
| Sensitivity | 95.52% |
| clinical sensitivity is 91.08% | 91.08% |
| Detection substance | Nucleic Acid |
| Certification | CE; ISO |
| Place of Origin | Beijing |
View Detail Information
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Product Specification
| Supply Ability | 1million per week | Delivery Time | 3-5working days |
| Packaging Details | 25pcs per case | Sample Type | Nasal/Throat Swab |
| Overall Agreement | 97.5% | Certificate | CE |
| Sensitivity | 95.52% | clinical sensitivity is 91.08% | 91.08% |
| Detection substance | Nucleic Acid | Certification | CE; ISO |
| Place of Origin | Beijing | ||
| High Light | Nasal Swab Rapid Diagnostic Test Kit ,Throat Swab Rapid Diagnostic Test Kit ,Nucleic Acid Diagnostic Throat Test kits | ||
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.
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Company Details
Business Type:
Manufacturer
Year Established:
2001
Total Annual:
1,000,000-5,000,000
Employee Number:
100~300
Ecer Certification:
Active Member
WUXI OWGELS MEDICAL INSTRUMENTS CO., LTD. was established in 2001, is a hi-tech manufacturer of oxygen concentrator with 20 years manufacturing experience in China. Main products are medical oxygen concentrators, respiratory therapy equipements and Covid-19 Antigen Rapid test ... WUXI OWGELS MEDICAL INSTRUMENTS CO., LTD. was established in 2001, is a hi-tech manufacturer of oxygen concentrator with 20 years manufacturing experience in China. Main products are medical oxygen concentrators, respiratory therapy equipements and Covid-19 Antigen Rapid test ...
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