Victory Square Health has been granted permission by the Food & Drug Administration (FDA) in the United States to commence marketing, sales and distribution under the emergency use authorization (EUA) for its Safetest 15 Minute Rapid Test Covid-19 assay.
Victory Square Health acquired Brazilian Covid19 test developers Safetest in June.
The Safetest 15 Minute Covid-19 Rapid Test enables the user to receive results with a 96.6% sensitivity in 15 minutes by a simple blood sample similar to that of a hand held diabetes reader that resembles a pregnancy test stick. This highly accurate test enables the participant to quickly detect if they have Covid-19 antibodies in 15 minutes.
The United States has seen over 7.8 million Covid-19 cases as of October 9, 2020. The Safetest 15 minute Covid-19 Rapid Test is designed to provide accurate data to people with the intention to help stop the spread of this virus. This FDA approval for the Safetest Covid-19 15-minute Rapid Test is in addition to the Elisa Test permission granted to the company by the FDA under EUA on August 25, 2020.
The clinical validation data provided by VS Health on Safetest Covid-19 IgM/IgG Rapid Test kit covers both immunoglobulin type M (IgM) and G (IgG). When IgM antibodies are present, they can indicate that a patient has an active or recent infection with SARS-CoV-2. When IgG antibodies are present, it indicates past infection and exposure.