A Covid-19 test, which can be performed at the care post and provides effects in 15 minutes, has been gently administered in Europe, according to its creator, Becton Dickinson.
The control is expected to be held commercially in Europe until the end of October, the diagnostic specialist said on Wednesday, announcing that its antigenic control had been “CE marked” in Europe, which means that it complies with health standards, protection and environmental criteria for products sold in the region.
The new check provides effects in 15 minutes on a small portable instrument, BD said, adding that it is a “critical improvement in the processing time of Covid-19 diagnostics as it provides real-time effects and allows decision making while the patient is still on site. “
“The addition of a portable service checkpoint can actually provide effects while the patient waits will be well received by health care providers and patients to help protect against other waves of Covid-19,” said BD EMEA Roland Goette.
He is by no means the one who will expand an immediate antigen control for the virus. Roche announced in September that its own 15-minute antigen control had won the CE marks and German diagnostic control manufacturer Qiagen also announced earlier this month that it planned to launch a 15-minute antigen control.
The U. S. Food and Drug Administration. It granted emergency use authorization in July to the company’s immediate antigen test, which works for proteins that can be discovered in or inside the Covid-19 virus.
It has been widely reported that while antigenic tests can be performed faster than molecular diagnostic tests performed in the laboratory, they are less accurate.
Becton Dickinson says clinical studies conducted at more than 20 sites in the United States have shown that verification is capable of achieving 84% sensitivity (a measure of how he identifies infections) and a specificity of one hundred percent (precisely identifies negative checks). ) however, the FDA recommends that the negative effects of the control be shown by a molecular approach to verify the result.
BD said it is its global production network and scale to produce 8 million Covid-19 antigen tests according to the month through October and expects to produce 12 million tests according to the month through March.
In mid-September, he reported that BD reviewing the infirmary reports that his Covid-19 immediate control device generates false positives in some cases.
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