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

As 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 ministration (FDA) on Friday approved Swiss pharmaceutical company Roche's improved rapid at-home test kits.

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

According to  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 or hand, as rapid at-home test kit makers are scrambling to meet soaring demands, Roche also claimed that it has capacity to produce "tens of millions" of tests per month. test includes a simple nasal swab to draw mucous for a quick check.

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

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

How does rapid at-home COVID test kit work?

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

antigen test detects structural or functional components of a pathogen and provides a qualitative yes or no. 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'

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

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

Meanwhile,  US CDC declared Omicron variant "dominant" over COVID-19 Delta variant, as it represented 73% of genome sequencing cases. As of December 23, 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  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. 

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