Two US companies have launched a rapid coronavirus antibody test, which can be used to detect whether a person’s immune system has or has recovered from Covid-19.
BD, a large medical technology company, and BioMedomics, a North Carolina-based clinical diagnostic company, have announced a new point-of-care test that can detect evidence of past or present exposure to the virus in as little as 15 minutes.
Serological tests are important because they could be used to assess people who are immune and therefore can be allowed to leave the lock to resume normal life – or to help others, in the case of health workers.
Public health officials can also use them to track the spread of the disease. But they are less accurate for diagnosis and cannot detect disease in the early stages.
Dave Hickey, President of Integrated Diagnostic Solutions for BD, said, “Serological tests are important because they provide additional information to help characterize possible prior exposure to Sars-CoV-2, especially since many infections are mild or asymptomatic. . ”
He added that the test could also be helpful in ruling out Covid-19 infection, as long as the patient waited a few days after symptoms appeared.
BD shares rose 3.1% to $ 229.77 in New York as it became the first large company to launch an antibody test in the United States.
In the United States, university laboratories and the United States Centers for Disease Control and Prevention are also working on the development of their own serological tests. China created antibody tests during its epidemic, and the British government has said it will have one ready in days rather than weeks.
The test can be distributed without regulatory approval because the U.S. Food and Drug Administration relaxed the rules during the public health emergency. The test must be labeled as not approved by the FDA and cannot be used as the sole diagnostic method.
BD plans to make one million tests available in the coming months, by distributing through its partner Henry Schein, a supplier of health products.
Instead of requiring a nasal swab, the test works on blood samples, which are then pipetted into a cartridge, alongside chemicals called pads, to produce a reading that looks like a pregnancy test.
Frank Wang, managing director of BioMedomics, said that the test was widely used in China during the epidemic and that its data was published in the Journal of Medical Virology.
“Our test has been clinically validated in several hospitals and clinical laboratories in the United States and China,” he said.