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CE Mark Certification Received for SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method)

CreateDate:2021-04-02
We're very pleased to announce that we have been awarded the CE marking for our SARS-CoV-2 Antigen Rapid Test (Colloidal Gold Method). The Declaration of Conformity for the test confirms that it meets the Essential Requirements of the European Community's In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of the product as an IVD to commence immediately in the European Community.

Based on the colloidal gold method to detect SARS-CoV-2 N antigen, our SARS-CoV-2 Antigen Rapid Test offers greater speed than PCR tests with high sensitivity and specificity. It can be used on both saliva and nasal swab samples. The sample collection is easy and simple. The test result can be visually read in 15 min.

Rapid testing and screening remain vital to the COVID-19 response, even as vaccine rollout gathers pace around the world. We are fully aware of the significance of rapid tests and endeavor to deliver high performance test to help fight the pandemic. Therefore, we are now scaling production in China and actively discussing new partnerships with international distributors and technology partners to roll out the test in new territories.