The US Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) for single used molecular in-vitro diagnostic test intended for COVID-19 self-testing at home. It can potentially detect the SARS-CoV-2 virus that causes Covid-19.
It is the first test authorised for home use with self-collected nasal swab samples in individuals aged 14 or above who are suspected of Covid-19 by their healthcare provider.
The test can be utilized in point-of-care (POC) settings, for example, doctor’s offices, urgent care centers, hospitals, and emergency rooms for all ages and for the people who are 13 years or less The sample collection must be carried out by a healthcare provider.
“There are currently two types of COVID-19 tests that detect whether a person is infected & potentially infectious. The tests detect viral proteins and provide results quickly. However, they are not diagnostically definitive and are more likely to miss an active coronavirus infection, or positive result, compared to molecular tests. Lucira’s Molecular tests are 50 to 60 times more sensitive than antigen tests and considered the ‘gold standard’ for determining if someone is infected." said Erik Engelson, CEO, Lucira Healthcare.
The testing procedure includes swap collection, stirring the sample vial which is later placed in the testing unit. The test gives results in 30 minutes or less and result can be read directly from the test unit’s light-up display. The size of the kit fits into the palm of your hand.
The studies showed clinically says that 100% of user who are 14 or older were able to run the test. The test is currently authorized for prescription use only.