Victory Square Technologies (VST.C) has received the declaration of conformity from the European Union (EU), designating that their COVID-19 rapid test is in compliance with all the requirements of the European in-vitro diagnostic device legislation (IVDD), according to a press release.
The designation gives the company the nod to start the marketing, sales and distribution process for its white label VS SARS-CoV-2 antigen rapid test used to detect the antigen of involved in the coronavirus. This designation carries through to December 2022.
“Rapid antigen test can contribute to overall COVID-19 testing capacity, offering advantages in terms of shorter turnaround times and reduced costs, especially in situations in which RT-PCR testing capacity is limited,” according to the European Centre for Disease Prevention and Control.
Their VS SARS antigen nasal rapid test gives test feedback in 15 minutes through using a simple test involving the swabbing of the inside of the nasal cavity and then replacing the swap inside a cartridge and waiting for the results. The Safetest approval gives Victory Square the ability to distribute their tech through 27 EU and EEA countries, with a combined population of 446,824,564. The company expects delivery to start on January first, 2021.
The World Health Organization’s (WHO) minimum performance requirements are greater than 80% sensitivity and greater than 97% specificity. The company’s clinical tests and performance studies have their test ranking at 92% sensitivity and 99.2% specificity, which far exceeds the standards set by WHO.
The company reports that they have now received CE EU approvals for its three COVID-19 testing products, including the 15 minute rapid antibody blood test, the ELISA lab-based test and today’s 15 minute nasal rapid test. These products cover the testing procedures required to detect the SARS COVID-19 virus at both the lab and point of care level.