CE Approved Covid-19 Antigen Rapid Test Kit Pharyngeal Test One Step Test

Covid-19 Antigen Rapid Test Kit Pharyngeal test one step test

This kit is a solid phase immunochromatographic sandwich assay that is intended for the rapid, qualitative and differential detection nucleocapsid protein antigen from SARS-CoV-2 in human oral saliva specimens.

Testing is only limited to professional laboratories.

The COVID-19 Antigen Rapid Test Kit is a lateral flow immunochromatographic assay. The test uses COVID-19 antibody (test line T) and goat anti-mouse IgG (control line C) immobilized on a nitrocellulose strip.
The burgundy colored conjugate pad contains colloidal gold conjugated to anti-COVID-19 antibody conjugated with colloid gold (COVID-19 conjugates) and mouse IgG-gold conjugates.

Clinical Performance of Antigen Test Kit
A total of 67 positive samples and 100 negative samples were detected to evaluate the clinical performance of the COVID-19 Antigen Rapid Test Kit.
The Result is below:

The assay demonstrated acceptable total clinical sensitivity 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: 97.66%-100%). Overall
Agreement was 98.68% (96.19%-99.55%).

WARNINGS AND PRECAUTIONS
1. For professional In Vitro diagnostic use only. Do not use after expiration date.
2. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
3. Do not use it if the pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any circumstances.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Humidity and temperature can adversely affect results.
8. Do not perform the test in a room with strong air flow, ie. electric fan or strong air- conditioning.
9. Test is only for oral saliva specimens If test other specimens such as nasal, throat or nasopharyngeal swab specimens or serumplasmaurine specimens, the results are only for research.
10. Sample collection and handling procedures require specific training and guidance.
11. Do not pour sample from the Extraction Tube into the Test Cassette sample well. Use the provided dispensing tip of Extraction Tubes when adding the sample to the Test Cassette.

WUXI OWGELS MEDICAL INSTRUMENTS CO., LTD.

was established in 2001, is a hi-tech manufacturer of oxygen concentrator with 20 years manufacturing experience in China.

Main products are medical oxygen concentrators, respiratory therapy equipements and Covid-19 Antigen Rapid test kits with the CE, SGS, FDA and ISO certificates. Our products already received unanimous praise from hundreds of our clients at home and abroad.

With outbreak of the COVID-19 virus, to provide epidemic prevention and control supplies to our old clients, in 2020, we established two more factories to produce disposable medical masks and KN95 masks. Besides these products, we also provide detection reagents.

1. Oxygen concentrators
2. Covid 19 Antigen Rapid Test Kits

3. Oxygen atomizer
4. Disposable medical face mask

5. KN95 medical face mask