• Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test
  • Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test
  • Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test
  • Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test
Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test

Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test

Product Details:

Place of Origin: Beijing
Certification: CE; ISO

Payment & Shipping Terms:

Minimum Order Quantity: 10-100pcs
Price: USD1.8-3.5/pc
Packaging Details: 25pcs per case
Delivery Time: 3-5working days
Supply Ability: 1million per week
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Detail Information

Clinical Specificity: 100% Overall Agreement: 96.21%
Certificate: CE Room Temperature Or Refrigerated: 2-30°C
Sensitivity: 95.52%
High Light:

Fast Swab Covid-19 Antigen Rapid Test Kit

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ISO Covid-19 Antigen Rapid Test Kit

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Fast Swab Clinical Diagnosis Test

Product Description

Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test

 CE Antigen Fast Diagnose Test for fresh swabs COVID-19 Antigen Rapid Test Kit Clinical Fast test

 

 PERFORMANCE CHARACTERCS

 The assay demonstrated excellent clinical specificity 100% (95% CI: 98.12%-100%). Overall Agreement was 96.21% (93.34%-97.87%).

 

 Clinical Performance of Antigen Test for fresh swabs

 Using 127 fresh NP swabs which were collected freshly in Extraction Buffer in the kit to evaluate the Clinical performance of the COVID-19  Antigen Rapid Test Kit. 67 Patients who presented within 7 days of symptom onset and 60 normal persons were included in the initial primary  evaluation. The Result is below:

 

    Sansure Covid-19 RT-PCR Assay
    Positive Negative Total
Kewei COVID-19 Antigen Rapid Assay Positive 64 0 64
Negative 3 60 63
Total 67 60 127
 

 The assay demonstrated acceptable clinical sensitivity for fresh swab samples is 95.52% (95% CI: 87.64%-98.47%) when compared to a  molecular device produced by Sansure Inc. The assay demonstrated excellent clinical specificity 100% (95% CI: 93.98%-100%). Overall  Agreement was 97.64% (93.28%-99.19%). 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%).

 

 1. 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%).

 

 2. 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.

 

 3. High-dose Hook effect

 No high dose hook effect was observed when test with up to a concentration of 6.3×105 TCID50/ml of heat inactive SARS-CoV-2 virus from  Academy of Military Sciences PLA China.

 

 

Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test 0

Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test 1

Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test 2

Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test 3

 

 

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