MachineU > China Products > Security & Protection > Surveillance Products > CCTV Lens
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
Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test
Fast Swab Covid-19 Antigen Rapid Test Kit Clinical Diagnosis Test
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
clinical specificity :
100%
Overall Agreement :
96.21%
Certificate :
CE
Room temperature or refrigerated :
2-30°C
Sensitivity :
95.52%
Description

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

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

Send your message to this supplier
Send Now

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

Ask Latest Price
Product Detail
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
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

Wuxi Owgels Medical Instruments Co., Ltd

Active Member
5 Years
jiangsu, wuxi
Since 2001
Business Type :
Manufacturer
Main Products :
Medical Oxygen Concentrator, Portable Oxygen Concentrator, 3 Liter Oxygen Concentrator
Total Annual :
1,000,000-5,000,000
Employee Number :
100~300
Certification Level :
Active Member
Discover similar products
View More

Find Similar Products By Category:

Supplier Homepage Products Covid-19 Antigen Rapid Test Kit
MachineU China Products Security & Protection Surveillance Products CCTV Lens
Contact Supplier
Submit Requirement