EUA for first rapid at-home COVID-19 testing kit to increase market share for POC tests: GlobalData

The test will reportedly cost around $50 and is currently authorised for prescription use only

On November 17, the US Food and Drug Administration issued an emergency use authorisation (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that detects the novel coronavirus SARS-CoV-2 that causes COVID-19.

The Lucira COVID-19 All-In-One Test Kit test has been authorised for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorised for use in point-of-care (POC) settings in the US (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorised for prescription use only.

The test kit includes the test device, sample vial, swab, and simple instructions. Two AA batteries are inserted in the device, and the sample vial is placed in the test unit. After this has been done, the user opens the test swab packet and rotates the swab in each nostril five times. The swab is then stirred in the sample vial. It is then pressed down in the test unit to start the test. The “ready” light then blinks. Within 30 minutes, a “positive” or “negative” green light is illuminated.

As per Lucira’s website, in a community testing study, where the Lucira test was compared to an FDA authorised known high sensitivity SARS-CoV-2 test, Lucira achieved a 94 per cent positive per cent agreement (PPA) and a 98 per cent negative per cent agreement (NPA). Excluding samples with very low levels of virus that possibly no longer reflected active infection, Lucira achieved 100 per cent positive per cent agreement. The test will reportedly cost around $50.

Dara Lo, medical device analyst, GlobalData, predicts that this EUA will see more POC COVID-19 tests come to market as they have the ability to relieve an overburdened healthcare and laboratory testing system, as well as offer customers the ability to self-test in the comfort and safety of one’s own home. Thus, this type of COVID-19 test is likely to be an attractive complement to current laboratory-based COVID-19 diagnostic testing.

According to GlobalData, COVID-19 POC tests account for more than a quarter of all PCR-based COVID-19 tests – also known as nucleic acid amplification tests (NAATs) – with single NAATs making up the majority of the COVID-19 diagnostic market and lastly multiplex NAATs holding a minor but significant share.