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4th January 2021  Content supplied by: Guangdong WESAIL Biotech Co., Ltd.

WESAIL COVID-19 Ag & Ab Tests Now Added to Lists of Approved Kits


WESAIL CE marked COVID-19 tests are now officially included in the Antigen and Antibody Test Approval Lists of the Paul-Ehrlich-Institut in Germany, the Ministero della Salute (Health Department) in Italy and the European Commission.

These recognitions has focused attention on the company, and close partnerships have been formed with distributors in Europe, boosting the demand for WESAIL COVID-19 tests in the region. 

The Paul-Ehrlich-Institut is an agency of the German Federal Ministry of Health, and a collaborative centre to WHO. The institution included WESAIL COVID-19 Ag Rapid Test in the list of approval SARS-CoV-2 antigen-tests, confirming satisfactory test performance of over 80% sensitivity and 97% specificity.

Download Paul-Ehrlich-Institut pdf of comparative evaluation of the sensitivities of SARSCoV-2 antigen rapid tests

Among hundreds of COVID-19 Ag Rapid Tests in the market, the Ministero della Salute currently has only greenlighted 22 tests. The WESAIL COVID-19 Ag test is one of the few brands approved by the institution, demonstrating performance comparable to other listed tests from top diagnostic brands, such as Abbott, Siemens and Quidel.

Registrations were also completed in the COVID-19 product lists of Ministero della Salute (the Health Department of Italy) and the European Commission, which confirmed that the performance of the WESAIL COVID-19 tests achieved the requirements of many countries in Europe.

See WESAIL product listing on Ministero della Salute, Italy

See WESAIL product listing on European Commission COVID-19 In Vitro Diagnostic Medical Devices

The increasing number of COVID-19 confirmed cases had boosted a more vital role in rapid screening, especially antigen tests that require no special equipment and indicate acute infection.

As a POC-focused brand, WESAIL will continue to leverage its technology to assist in pandemic control and prevention. The company welcomes IVD partners to sign up via FREE SAMPLE for the application of COVID-19 Ag and IgM/IgG Ab test samples with NO CHARGE.


    

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Date Published: 4th January 2021

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