Becton Dickinson will be launching its 15-minute Covid-19 test in Europe by the end of October, according to the company's announcement.
The diagnostic specialist said its antigen test had received a “CE mark” in Europe. The CE mark attests that its coronavirus test adheres to health, safety, and environmental protection standards for items sold within the region.
According to Becton Dickinson, the Covid-19 test shows results in 15 minutes on a small, portable instrument. The company stressed 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.
Moreover, BD reports that clinical studies held at more than 20 sites across the US proved that the test can reach 84% sensitivity (a measure of how well it correctly identifies infections) and 100% specificity (how well it correctly identifies negative tests) but the FDA prefers that negative test results be tested by a molecular method to verify the result.
BD's global manufacturing network and scale allow the maker to develop 8 million Covid-19 antigen tests per month by October. The company plans to distribute 12 million tests per month by March.
Rapid tests
Last month, a similar company, Roche said it will launch its rapid coronavirus test in Europe, and the test will be used for point-of-care settings for asymptomatic and symptomatic patients.
The Roche rapid coronavirus test usually reveals the results in about 15 minutes. Accordign to the company, the test accurately presents diagnosis of an infected Covid-19 patient more than 96% of the time. It also presents a negative result more than 99% of the time, based on a combined sample size of 426 samples from two different testing centers.
“This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected to carry the virus with results typically ready in 15 minutes,” Roche said in a release.
“In addition, it serves as a valuable initial screening test for individuals that have been exposed to SARS-CoV-2 infected patients or a high risk environment.”
Roche said that the test is “affordable” but did not reveal its price. The company clarified that it does not require technical lab equipment. The test can also be used where rapid and large-scale testing is needed.
“This is highly beneficial where timely decisions are needed or laboratory testing is inaccessible,” Roche said in the release. “The test will help to quickly identify people who are infected and allows better patient management as well as more effective use of healthcare resources.”
When the test gets introduced at the end of the month, Roche said it will be able to deliver 40 million tests every month and it plans to double that capacity by the end of 2020. Roche also said it came up with the test in partnership with SD Biosensor.
“Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment,” Roche’s CEO Thomas Schinecker said in a statement.
“COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus,” he said.
