News_News_Guangdong Wesail Biotech Co.,Ltd.

Recognition Gained on WESAIL COVID-19 Tests, Test Demand Raising in Europe

WESAIL CE-Cleared COVID-19 Tests are now officially included in the Antigen and Antibody Test Approval Lists of the Paul-Ehrlich-Institut in Germany and the Ministero della Salute (Health Department) in Italy. The recognition led great attention to the company, and close partnerships were formed with distributors in Europe, boosting the demand for WESAIL COVID-19 tests in the region. (Image: WESAIL COVID-19 Antigen Rapid Test Kit) 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-cov2-antigen-tests, confirming satisfactory test performance of over 80% sensitivity and 97% specificity. Among hundreds of COVID-19 Ag Rapid Tests in the market, the Ministero della Salute only greenlighted 22 tests currently. WESAIL COVID-19 Ag Test is one of the few brands approved by the institution, demonstrated performance comparable to other listed tests from top diagnostic brands, such as Abbott, Siemens and Quidel. (Screenshot image from https://www.pei.de/SharedDocs/Downloads/EN/newsroom-en/dossiers/evaluation-sars-cov2-antigen-tests-overview-04-12-2020.pdf?__blob=publicationFile&v=3) WESAIL COVID-19 IgM & IgG Ab Test and COVID-19 Ag Test also achieved the requirement of Italian Ministry of Health and completed registration in the manufacturing list of Ministero della Salute (the Health Department of Italy). (Search WESAIL from http://www.salute.gov.it/interrogazioneDispositivi/RicercaDispositiviServlet?action=ACTION_MASCHERA) 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.

Initial Order Received! 500,000 WESAIL Antigen Tests Ship to Europe in Fighting COVID-19 Pandemic

With the launch of the new COVID-19 Ag Test in September, in complimentary to WESAIL IgM/IgG Antibody Test to offer a complete COVID-19 diagnosis solution in fighting the global pandemic, WESAIL Biotech successfully entered the markets in Italy, Spain, Germany, Netherland and others. For the recent resurgences of COVID-19 reported in many parts of the world, countries had turned to rapid antigen test for epidemic control. With WESAIL COVID-19 Ag Test approved by Germany’s Federal Institute for Drugs and Medical Devices in the COVID-19 Ag test list, WESAIL had received significant attention from the IVD industry. Business cooperations are established in various countries of Europe, obtaining initial order of more than 500,000 Ag tests to ship in November and December. To continue the efforts in fighting COVID-19 pandemic, IVD partners can apply for samples of COVID-19 Ag and IgM/IgG Ab tests with NO CHARGE via FREE SAMPLE. WESAIL COVID-19 rapid tests offer performances that extend beyond industry standards with the following features. WESAIL COVID-19 CE-Marked 15 Min Antigen Test Kit (Awaiting EUA-FDA) 1.90% sensitivity & 98% specificity 2.LoD = 8x102 TCID50/mL 3.Result in 15 min 4.For nasopharyngeal or nasal swabs and viral transport media samples 5.Individual & 20 tests packaging for different applications WESAIL COVID-19 IgM/IgG Antibody Test 1.99% specificity & ≥90% sensitivity 2.Result in 6 min 3.Rapid detection of IgM & IgG antibodies in one single test 4.Individual & 20 tests packaging for different applications

WESAIL has participated in the "2020 Dongguan International Epidemic Prevention Exhibition".

From October 19 to 20, 2020, Guangdong Wesail Biotech Co., Ltd. has participated in the "2020 Dongguan International Epidemic Prevention Exhibition". Four COVID-19 products independently developed by WESAIL were exhibited, including the COVID-19 Antigen Test Kit, COVID-19 IgM/IgG Test Kit, COVID-19 IgM Test Kit and COVID-19 IgG Test Kit.

WESAIL COVID-19 Test Kit has obtained the export qualification by the China Chamber of Commerce

On June 17, 2020, WESAIL Coronavirus COVID-19 lgM/IgG Test Kit has passed the review by the China Chamber of Commerce for Import & Export of Medicines & Health Products and has obtained the export qualification in the whitelist of “Medical Devices and Supplies Companies with Certification/Authorization from other Countries”. According to the requirements of the latest announcement, as the product has obtained the EU CE certificate, the product is allowed to export with a written statement declaring that the product meets the quality standards and safety requirements of the destination. The simplification of export procedures will facilitate the international sales of the product and help to fight against global COVID-19.

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Recognition Gained on WESAIL COVID-19 Tests, Test Demand Raising in Europe

Initial Order Received! 500,000 WESAIL Antigen Tests Ship to Europe in Fighting COVID-19 Pandemic

WESAIL has participated in the "2020 Dongguan International Epidemic Prevention Exhibition".

WESAIL COVID-19 Antigen & IgM/IgG Test Kits have obtained the CE certificate issued by the Netherlands CIBG

WESAIL COVID-19 Test Kit has obtained the export qualification by the China Chamber of Commerce