Sansure Biotech’s SARS-CoV-2 Rapid Antigen Test Included in EU HSC Common List
2021-12-30 yang, rongchang

Sansure Biotech’s SARS-CoV-2 Rapid Antigen Test Included in EU HSC Common List


Sansure Biotech Dec 30,2021

On December 21,  a SARS-CoV-2 Rapid Antigen Test (Colloidal Gold Method) developed by Sansure Biotech was included in EU Health Security Committee (HSC) Common List. Hence, the product has been accredited by yet another international certification body, following its CE certification and inclusion in the common lists of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Greek Medical Devices Information System (GreMDIS).

Against the backdrop of the currently grim pandemic of COVID-19, antigen test kits for their fast speed, convenient operation, low cost, and narrower window phase than antibody test kits have become the effective supplement to currently available assays. Sansure Biotech SARS-CoV-2 Rapid Antigen Test directly detects the nucleocapsid protein of SARS-CoV-2 by simple operation without the need for specialized equipment and provides visualized results in mere 15-20 minutes (from sampling to result reporting). For its ability to detect positive cases in the phase of acute infection when the viral load is high, the kit is ideal for early diagnosis and fast screening of suspected population.

Numerous products for fast diagnosis of COVID-19 are commercially available at present and the official website of EU has provided a list of hundreds of SARS-CoV-2 Rapid Antigen Test products, all of which have the CE marking. EU HSC has stipulated more rigorous requirements for SARS-CoV-2 Rapid Antigen Test and required manufacturers to provide more convincing validation documents on product performance in support of their products’ eligibility for inclusion in the EU HSC Common List.

With the COVID-19 pandemic becoming regular, there is increasingly more demand for SARS-CoV-2 Rapid Antigen Test products in the EU market. Sansure Biotech SARS-CoV-2 Rapid Antigen Test has been well-recognized by users for its highly commendable quality. By constantly upgrading its products in response to the development trend of the COVID-19 pandemic for improved clinical detection rate and guaranteed detection of emerging SARS-CoV-2 variants, Sansure provides reliable support to the prevention and control of the COVID-19 pandemic. The inclusion of this kit in the EU HSC Common List indicates that the product has been accredited by EU official laboratory and the product’s performance has been validated in terms of both clinical data and technical documents.