In an effort to make Covid-19 testing accessible to each and every US citizen, the FDA issued on Tuesday an Emergency Use Authorization for the use of the Lucira COVID-19 All-In-One Test Kit, pursuant to section 564 of the FD&C Act.
Based on a molecular amplification technology that detects the novel coronavirus in people's RNA (ribonucleic acid), the COVID-19 All-In-One Test Kit produced and distributed by the Emeryville, CA-based medical equipment manufacturer Lucira Health, Inc. is the first at-home self-test for detection and diagnosis of SARS-CoV-2.
This complete and rapid single-use test kit is intended for prescription home use in individuals aged 14 and older with suspected COVID-19, as well as for use in point-of-care (POC) settings for individuals of all ages, but a healthcare provider must collect the nasal swab specimen in those aged 13 and younger.
The kit includes a sample vial, a sterile nasal swab, batteries, a test unit (where results are displayed), and a plastic disposal bag.
The user has to swirl the self-collected nasal swab in the sample vial and then place the vial in the test unit. In 30 minutes or less, the test unit's LED display will show whether the person is negative or positive for COVID-19. Lucira COVID-19 All-In-One Test Kit is expected to cost around $50.
Lucira states on its website: “In a Community Testing Study, where the Lucira test was compared to a FDA authorized known high sensitivity SARS-CoV-2 test, Lucira achieved a 94% positive percent agreement (PPA) and a 98% negative percent agreement (NPA). Excluding samples with very low levels of virus that possibly no longer reflected active infection, Lucira achieved 100% positive percent agreement.”
I can't imagine that this is going to be any better than the tests that we already have since these are tests that people can administer to themselves. The ones we have now are highly inaccurate already.