FDA authorises a second Covid-19 antigen test


Bouncing back from the shame of having the FDA revoke the emergency use authorisation for the Covid-19 antibody test it was distributing, Becton Dickinson today became the second group to gain EUA for an antigen test. These assays are used to diagnose active Covid-19 infections but do so by detecting viral proteins rather than the virus’s RNA. While antigen tests are faster and cheaper than molecular tests, they tend to be less accurate. BD’s test can be conducted at the patient’s bedside – it runs on the handheld Veritor machine, which is in use in about 25,000 hospitals and doctors’ offices in the US – rather than the sample being sent off to a lab. Over the past week, two more tests to detect antibodies to the novel coronavirus and five molecular tests developed by for-profit companies have been authorised. The second home sample collection kit has been greenlit too; this is being sold by the supermarket chain Kroger, with the samples being analysed by a clinical laboratory called Gravity Diagnostics. Patients who are prescribed this test will have a video call with a healthcare professional to observe and guide them while taking their own nasal swab.

Note: "Other" includes two antigen tests, two home sampling kits and one IL-6 test.

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