In the fight against the Coronavirus pandemic, rapid detection of the disease is key.
Under normal conditions, a company must demonstrate the efficacy and safety of their new in vitro diagnostic (IVD) test before it can be approved by the Food and Drug Administration (FDA) in the U.S. However, during public health emergencies, when there are no adequate tests available, the FDA can fast track the process by issuing Emergency Use Authorizations (EUA).
All test approvals granted under EUA are valid while the emergency status is in place.
Just mere months into the COVID-19 pandemic, there are already several diagnostic tests available with varying degrees of sensitivity, specificity and time to result. However, considering the high infection rate of the novel virus, it is essential to minimize time to result, allowing rapid response to having control measures that stop the spread of the virus. Point of Care (POC) diagnostics can rise to the challenge by providing accelerated time to result at the point of need.