The US Food and Drug Administration (FDA) has issued an emergency use authorisation for the first Covid-19 diagnostic kit for self-testing at home.
“Lucira Health’s single-use Covid-19 all-in-one test kit is easy to use and produces a positive or negative result within 30 minutes,” said Lucira CEO Erik Engelson, adding clinical trials showed 100% of patients were successfully able to perform the test in about two minutes.
“There are currently two types of Covid-19 tests that detect whether a person is infected and potentially infectious,” said Engelson. “Antigen tests detect viral proteins and can 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. Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests and considered the ‘gold standard’ for determining if someone is infected.”
The compact Lucira kit extracts genetic material from the virus and amplifies it. This process takes up to 30 minutes, but a positive test result can be generated in as few as 11 minutes.