Two US companies have launched a rapid antibody test for the coronavirus, which can be used to detect if a person’s immune system has Covid-19 or has recovered from it.
BD, a large medical technology company, and BioMedomics, a North Carolina-based clinical diagnostics company, 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.
The so-called serological tests are important because they could be used to assess who may be immune and can therefore be allowed to leave lockdown to return to normal life — or to help others, in the case of healthcare 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 the disease in the earlier stages.
Dave Hickey, president of integrated diagnostic solutions for BD, said: “Serology tests are important because they provide an additional piece of information to aid in characterising possible prior exposure to SARS-CoV-2, especially since many infections are mild or asymptomatic in severity.”
He added that the test could also be useful in ruling out a Covid-19 infection, as long as the patient waited a few days after symptoms developed.
Shares in BD rose 3.1 per cent to $229.77 in New York, as it became the first major company to launch an antibody test in the US.
In the US, academic labs and the US Centers for Disease Control and Prevention are also working on developing their own serologic tests. China created antibody tests during its outbreak, and the UK government said it will have one ready in days, rather than weeks.
The test can be distributed without regulatory approval because the US Food and Drug Administration has loosened the rules during the public health emergency. The test must be labelled as not approved by the FDA and it cannot be used as the sole method of diagnosis.
BD plans to make a million tests available in the coming months, distributing through its partner healthcare supplies company Henry Schein.
Instead of requiring a nasal swab, the test works on blood samples, which are then pipetted into a cartridge, alongside chemicals known as buffers, to produce a reading that looks like a pregnancy test.
Frank Wang, chief executive of BioMedomics, said the test was used widely in China during the outbreak and its data has been published in the Journal of Medical Virology.
“Our test has been clinically validated at several hospitals and clinical laboratories in both the US and China,” he said.