US FDA approves improved rapid at-home COVID test kit as hotspots face acute shortage

As the United States is grappling to meet demands for at-home COVID testing kits fuelled by skyrocketing COVID-19 cases coinciding with Omicron, Food and Drug Administration (FDA) on Friday approved Swiss pharmaceutical company Roche's improved rapid at-home test kits.

In a statement released by the company, Roche announced that its at-home COVID test kits have been endorsed for Emergency Use Authorisation (EUA), and it will be ready for a massive rollout from January 2022 across the US.

According to the press release, Roche's test kit can provide results within 20 minutes and can be used independently by people as young as 14 years old. On the other hand, as rapid at-home test kit makers are scrambling to meet the soaring demands, Roche also claimed that it has the capacity to produce "tens of millions" of tests per month. The test includes a simple nasal swab to draw the mucous for a quick check.

"The covid-19 continues to shed light on the critically important role that rapid self-testing plays in empowering individuals to protect the personal health and the health of their families and communities," Roche Diagnostics CEO Thomas Schinecker said in a statement.

"At this infection point in the American public fight against COVID-19, we are proud to have worked in close collaboration with the US government to introduce and expand access to accurate, reliable and high-quality at-home tests," he added.

How does the rapid at-home COVID test kit work?

The COVID-19 at-home test kit is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of the SARS-CoV-2 present in the anterior nasal swab sample, Roche said in its statement. In a prospective clinical study, the kit showed relative sensitivity of 95.3% and relative specificity of 100%.

The antigen test detects the structural or functional components of a pathogen and provides a qualitative yes or no. The test is ideal for non-prescribed homes used for symptomatic or asymptomatic suspects of COVID or related infections when tested twice over three days with at least a 24-hour gap between tests.

Biden says 'nothing's been good enough'

The approval comes two days after President Joe Biden on Wednesday acknowledged that "nothing has been good enough," as COVID-19 hotspots in the US pharmacies display empty shelves for independent COVID test kits.

Speaking to ABC News, Biden also conceded that his administration has struggled to meet the requirements of robust testing demands. Biden's statement came as there has been a steady influx in COVID-related patients in emergency rooms and intensive care units.

Meanwhile, the US CDC declared the Omicron variant "dominant" over the COVID-19 Delta variant, as it represented 73% of the genome sequencing cases. As of December 23, the US clocked over 2,65,032 COVID cases along with 1 7-day average of over 1 lakh cases, according to data compiled by John Hopkins University. 

California topped the list with 52.9 lakh infections, with Texas, Florida and New York following with 44.7 lakh, 38.6 lakh and 31 lakh COVID-19 cases respectively. 

(Image: AP/Shutterstock)