• 0.3KG Throat Swab Coronavirus Test Kit Clinical Performance
  • 0.3KG Throat Swab Coronavirus Test Kit Clinical Performance
  • 0.3KG Throat Swab Coronavirus Test Kit Clinical Performance
  • 0.3KG Throat Swab Coronavirus Test Kit Clinical Performance
0.3KG Throat Swab Coronavirus Test Kit Clinical Performance

0.3KG Throat Swab Coronavirus Test Kit Clinical Performance

Product Details:

Place of Origin: Beijing
Certification: CE; ISO

Payment & Shipping Terms:

Minimum Order Quantity: 10-100pcs
Price: negotiable
Packaging Details: 25pcs per case
Delivery Time: 3-5working days
Supply Ability: 1million per week
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Detail Information

Specificity: 100% Overall Agreement: 97.5%
Sample Type: Nasal/Throat Swab Assay Incubation: 15minutes, RT
Format: 25T/Kit N.W.: 0.3KG
Number Of Box: 50Kits
High Light:

25T/Kit Coronavirus Test Kit

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0.3KG Coronavirus Test Kit

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Throat Swab Coronavirus Test Kit

Product Description

0.3KG Throat Swab Coronavirus Test Kit Clinical Performance

 COVID-19 Antigen Rapid Test Kit Clinical Performance of Antigen Test for fresh swabs

 

 PERFORMANCE CHARACTERCS

 

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

 

1. 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%).

 

 2. 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%).

 

 4. 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.

 

 5. 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.

 

6. 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(308TCID 50/ml),  No cross-reactivity or interference was seen.

 

 

 

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