Specifications
Certification :
CE; ISO
Place of Origin :
Beijing
MOQ :
10-100pcs
Price :
USD1.8-3.5/pc
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
Description

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.


Throat Swab Rapid Diagnostic Test Kit , Nucleic Acid Diagnostic Throat Test kits

Throat Swab Rapid Diagnostic Test Kit , Nucleic Acid Diagnostic Throat Test kits

Throat Swab Rapid Diagnostic Test Kit , Nucleic Acid Diagnostic Throat Test kits

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Throat Swab Rapid Diagnostic Test Kit , Nucleic Acid Diagnostic Throat Test kits

Ask Latest Price
Certification :
CE; ISO
Place of Origin :
Beijing
MOQ :
10-100pcs
Price :
USD1.8-3.5/pc
Supply Ability :
1million per week
Delivery Time :
3-5working days
Contact Supplier
Throat Swab Rapid Diagnostic Test Kit , Nucleic Acid Diagnostic Throat Test kits
Throat Swab Rapid Diagnostic Test Kit , Nucleic Acid Diagnostic Throat Test kits
Throat Swab Rapid Diagnostic Test Kit , Nucleic Acid Diagnostic Throat Test kits
Throat Swab Rapid Diagnostic Test Kit , Nucleic Acid Diagnostic Throat Test kits

Wuxi Owgels Medical Instruments Co., Ltd

Active Member
5 Years
jiangsu, wuxi
Since 2001
Business Type :
Manufacturer
Total Annual :
1,000,000-5,000,000
Employee Number :
100~300
Certification Level :
Active Member
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