• COVID-19 Rapid Diagnostic Throat Test Kits OEM 95.52% Sensitivity
  • COVID-19 Rapid Diagnostic Throat Test Kits OEM 95.52% Sensitivity
  • COVID-19 Rapid Diagnostic Throat Test Kits OEM 95.52% Sensitivity
  • COVID-19 Rapid Diagnostic Throat Test Kits OEM 95.52% Sensitivity
COVID-19 Rapid Diagnostic Throat Test Kits OEM 95.52% Sensitivity

COVID-19 Rapid Diagnostic Throat Test Kits OEM 95.52% Sensitivity

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% Clinical Sensitivity Is 91.08%: 91.08%
Material: Plastic
High Light:

COVID-19 Rapid Diagnostic Throat Test Kits

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OEM Rapid Diagnostic Throat Test Kits

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OEM Covid-19 Antigen Test Kit

Product Description

COVID-19 Rapid Diagnostic Throat Test Kits OEM 95.52% Sensitivity

ISO Rapid Diagnostic Throast Test Kits Certificated with CE Antigen Test for fresh swabs COVID-19 Antigen China OEM

 

 PERFORMANCE CHARACTERCS

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%).

 

 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.

 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.

 

 Cross Reactivity

 Many types of pneumonia are companied by fever, cough and other respiratory symptoms. In order to eliminate similar clinical symptoms of other  types of pneumonia effects, pneumonia mycoplasma, influenza A, pneumococcus etc. were detected for the specific assessment. Each of the  organism and viruses were tested in the absence or presence of heat inactivated SARS-CoV-2 virus (308 TCID50/ml), No cross-reactivity or  interference was seen.

Potential Cross-Reactant Test Concentration Result
Absence of SARS-CoV-2 presence of SARS-CoV-2
Staphylococcus aureus 1.0×105 TCID50/ml +
Streptococcus pneumoniae 1.0×106 Cells/ml +
Measles virus 1.0×105 TCID50/ml +
Mumps virus 1.0×105 TCID50/ml +
Adenovirus type 3 1.0×105 TCID50/ml +
Mycoplasma pneumoniae MP 1.0×106 Cells/ml +
Parainfluenza type 2 1.0×105 TCID50/ml +
Metapneumovirus 1.0×105 TCID50/ml +
Coronavirus OC43 1.0×105 TCID50/ml +
Coronavirus 229E 1.0×105 TCID50/ml +
Bordetella parapertussis 1.0×106 Cells/ml +
Influenza B virus (Victoria series) 1.0×105 TCID50/ml +
Influenza B virus (Y series) 1.0×105 TCID50/ml +
Influenza A H1N1 (2009) virus 1.0×105 TCID50/ml +
Influenza A H3N2 virus 1.0×105 TCID50/ml +
Avian influenza virus H7N9 1.0×105 TCID50/ml +
Avian influenza virus H5N1 1.0×105 TCID50/ml +
EB virus 1.0×105 TCID50/ml +
Enterovirus CA16 1.0×105 TCID50/ml +
Rhinovirus 1.0×105 TCID50/ml +
         
 

 

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