New Delhi: The US Food and Drug Agency, the country’s apex drug regulator, recently approved a rapid Covid-19 test that allows people to test themselves for the infection at home.
The test BinaxNOW, developed by US pharmaceutical company Abbott Laboratories, costs $25 and is an antigen test that delivers results in 15 minutes. Till now, the test had been administered to only health-care providers.
Robert Ford, Abbott’s chief executive officer, noted in a statement, “The test allows us to maintain the integrity of the testing process, get even closer to people who need testing and help provide the confidence we need to help get back to living with a bit more normalcy.”
While home collection kits have been in the market for some time now, only three such at-home kits have been approved by the FDA.
Aside from Abbott’s BinaxNOW, they are Lucira Health Inc.’s All-In-One-Test kit and the Ellume test.
ThePrint looks at all three of them and compares them in terms of specificity, which is the ability to identify those with the disease, and sensitivity — the ability to identify those without the disease.
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Abbott’s BinaxNOW
A single-use swab collected test, the Abbott test can be taken at home with virtual assistance and produces results within 15 minutes. Consumers will be given virtual guidance by certified guides from a partnering company known as eMed.
The rapid antigen test will cost $25 and can only be ordered through a smartphone app called Navica after answering some health questions. According to interim results from a study of 52 people, the test has a sensitivity of 91.7 per cent and specificity of 100 per cent.
Last month, however, a study of more than 1,600 people in the US state of Massachusetts had raised concern about the efficacy of the test, especially when used by young people.
The study found that when the test was taken by symptomatic people of 18 years or below, its sensitivity was just 77.8 per cent.
Ellume
Australian company Ellume received an emergency authorisation for its rapid Covid test from the FDA Tuesday.
The rapid antigen test kit includes a nasal swab, a dropper, a processing fluid and a bluetooth-connected analyser. Results of the test are transmitted to the user’s phone within 15 minutes or less.
“Ellume’s COVID-19 Home Test delivers this important first line of defense – it can be widely available without the need for a prescription, enabling the US to respond to the pandemic in its most urgent stage,” Ellume founder and CEO, Dr Sean Parsons said in a statement Tuesday.
A clinical study of about 200 people had shown that the test had 95 per cent sensitivity and 97 per cent specificity.
The kit costs $30 or less and is said to work best in people with symptoms.
A pathologist from Rutgers University noted that all the study’s false positives had occurred in the asymptomatic group.
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Lucira
The rapid Covid testing kit developed by Lucira Health, another American pharmaceutical company, was the first at-home kit to be approved by the FDA in November.
The Covid-19 All-In-One Test Kit is a single-use molecular-based test kit that works by amplifying the viral matter. The test requires a prescription to be administered.
Highlighting the difference between the Lucira test and other antigen tests, CEO Erik Engelson had said, “Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests, and considered the ‘gold standard’ for determining if someone is infected.”
It costs about $50 and produces results within 30 minutes. To use the test, one has to swirl the nasal specimen into a solution and then plug the vial into a portable, battery-operated device.
A negative or positive green light will blink once the device is done processing the sample.
Data from a study involving 100 people indicated that the test has a sensitivity of 94.1 per cent and specificity of 98 per cent.
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