COVID-19 (SARS-CoV-2) Antigen Test Kit Nasal Swab (Self-testing)

Senciticity:96.4%(95%CI:90.8%-98.2%)


Specificity:99.8%(95%CI:94.4%-99.9%)

COVID-19 Antigen Self-test Kit
COVID-19 Antigen Self-test Kit
  • Product Detail

Intended use


This product is used for in vitro qualitative detection of the SARS-CoV-2 antigen in human nasal swab specimen. It is intended for personal use by untrained layman as a rapid test method for novel coronavirus infection. 



Test principle


This product uses the double antibody sandwich method to detect the SARS-CoV-2 N protein. When the sample contains the coronavirus antigen, both the test line (C) and the control line (T) will appear, and the result will be positive. When the sample does not contain the coronavirus antigen or no coronavirus antigen is detected, the test line (T) will not appear, only control line (C) will appear.



Product advances


1.Pre-filled buffer solution, easier operation. 
2.Passed the PEI evaluation. 
3.Room temperature storage.
4.No need instrument, get results within 15 minutes.
5.Identify acute or early infection.
6.No reduction in sensitivity test against the Alpha, Beta, Delta, Gamma, Lambda, Omicron variant and so on. 



Materials and Components


1.Test Device

2.Instruction

3.Antigen Extraction Tube with Extraction Reagent

4.Collection Bag

5.Sterilized Swab

6.Timer(Materials required but not provided)



Product Information


Specification 1pcs/box,5pcs/box,25pcs/box
Specimen Human Anterior Nasal Swab
Storage 4-30℃




Test Procedure


Allow test device extraction reagent and specimens to equilibrate to room temperature(15 ~ 30 ℃) prior to testing.Please keep the temperature at 15 ~ 30 ℃ and the humidity at20%-80% during the whole test.


1.Specimen Collection

(1)Remove the sterilized swab from the packaging.

(2)Roll the swab firmly around the inside of the nostril, making 5 complete circles. Using the same swab, repeat this process for the other nostril.

2.Testing



3.Test Results

Read result at 15 minutes.Do not read results after 30minutes. 






Clinical Performance


There were 520 cases overall in the study, including 110 positive samples and 410 negative samples. Statistics of nasal swab test results were as follows:


Reference RT-PCR Assay

95% Wilson Score CI

LCI

UCI

DEEPBLUE 

SARS-CoV-2

Ag Test

 

POS

NEG

Total

PPA

96.4%

90.8%

98.2%

POS

106

1

107

NPA

99.8%

94.4%

99.9%

NEG

4

409

413

PPV

99.1%

93.7%

99.8%

TOTAL

110

410

520

NPV

99.0%

93.5%

99.7%


Sensitivity: 96.4% (95% CI: 90.8% - 98.2%)

Specificity: 99.8% (95% CI: 94.4% - 99.9%)


IFU_DE_CE Ag Self Test



Leave A Message
If you have questions or suggestions,please leave us a message,we will reply you as soon as we can!
Related Products
We Are Looking Forward To Establishing Relationships With You In The Near Future.
SEND A MESSAGE
If you have questions or suggestions,please leave us a message,we will reply you as soon as we can!
  • # Address

    Pearl Industrial Park,106 Innovation Avenue, High-Tech Development Zone / No. 777 Jimingshan Road, High-Tech Development Zone, 230088 Hefei, Anhui, PEOPLE'S REPUBLIC OF CHINA

  • # Call Us

    Tel : +86-551-65326797

  • # email us

    Email : sales@dbluemedical.com

top
Leave A Message
Leave A Message
If you have questions or suggestions,please leave us a message,we will reply you as soon as we can!

Home

Product