Europe has approved a test for Covid-19 that can yield results in just 15 minutes and can be done at the point of care without the need for elaborate testing facilities, said Becton Dickinson, the maker of the test kit.
The diagnostics specialist said that the new Cvoid-19 test should be commercially available in Europe by the end of October. The maker announced that its antigen test had been granted a “CE mark” in Europe which means that the test conforms to health, safety, and environmental protection standards for products that are sold within the continent.
BD said that a small, portable instrument is used for the new test with the ability to deliver results in 15 minutes. It added that this is a “critical improvement in turnaround time for Covid-19 diagnostics, because it provides real-time results and enables decision-making while the patient is still onsite.”
“The addition of a truly portable, point-of-care test that can deliver results while the patient waits will be welcomed by health care providers and patients alike to help protect against additional waves of Covid-19,” BD EMEA Roland Goette said.
There are however several other firms that are also engaged in development of a rapid antigen test for the novel coronavirus. The CE mark had been given to a 15-minute antigen test from Roche, the company had announced earlier in September. Plan to launch a similar 15-minute antigen test was also announced by the German diagnostic test maker Qiagen.
In July, emergency use authorization to the company’s rapid antigen test was granted by the United States Food and Drug Administration. This test looks out for proteins that can be found on or inside the Covid-19 virus.
It has however been touted that while rapid antigen tests are much faster than the molecular diagnostic tests conducted in laboratories, the accuracy of such tests are also lower.
The 15 minute test of Becton Dickinson is capable of achieving an 84 per cent sensitivity (a measure of how well it correctly identifies infections) and 100% specificity (how well it correctly identifies negative tests), claimed the maker based on clinical studies performed at more than 20 sites across the US. But the recommendations from the FDA is to conduct a molecular method test to confirm any negative result delivered by the rapid antigen test.
With the aim of manufacturing 8 million Covid-19 antigen tests per month by October, it is leveraging its global manufacturing network and scale, BD said, and added that it expects that by March, it would be in a position to produce 12 million tests per month.
It was reported in mid-September that reports from nursing homes about the usage of its rapid antigen tests delivering false positive results in some cases were being looked at by BD.
(Adapted from CNBC.com)