U.S. companies, labs rush to produce blood test for coronavirus immunity
(Reuters) - As the United States works overtime to screen thousands for the novel coronavirus, a new blood test offers the chance to find out who may have immunity - a potential game changer in the battle to contain infections and get the economy back on track.
Several academic laboratories and medical companies are rushing to produce these blood tests, which can quickly identify disease-fighting antibodies in people who already have been infected but may have had mild symptoms or none at all. This is different from the current, sometimes hard-to-come-by diagnostic tests that draw on a nasal swab to confirm active infection.
“Ultimately, this (antibody test) might help us figure out who can get the country back to normal,” Florian Krammer, a professor in vaccinology at Mount Sinai’s Icahn School of Medicine, told Reuters. “People who are immune could be the first people to go back to normal life and start everything up again.”
Krammer and his fellow researchers have developed one of the first antibody tests in the United States for COVID-19, the disease caused by the new coronavirus. Krammer said his lab is busy distributing key ingredients for the tests to other organizations and sharing the testing procedure. He is transferring the work to Mount Sinai’s clinical lab this week so it can begin testing patient samples.
Antibody tests won’t face the same bureaucratic hurdles diagnostic testing initially did. The U.S. Food and Drug Administration relaxed its rules last month, and body-fluid tests can proceed to market without full agency review and approval.
Several private companies have begun selling blood tests for COVID-19 antibodies outside the United States, including California-based Biomerica Inc and South Korean test maker Sugentech Inc. Biomerica said its test sells for less than $10 and the company already has orders from Europe and the Middle East. Chembio Diagnostics Inc of New York said it received a $4 million order from Brazil for its COVID-19 antibody test, and it plans a study of the test at several sites in the United States.
Such tests are relatively inexpensive and simple, usually using blood from a finger prick. Some can produce results in 10 to 15 minutes. That could make ramping up screening much easier than for diagnostic tests.
Many questions remain, including how long immunity lasts to this new virus, how accurate the tests are and how testing would roll out, according to researchers and infectious disease experts. For now, the number of people who have been able to fight off the virus is unknown.
If testing goes forward on a wider scale, some public health experts and clinicians say healthcare workers and first responders should take priority.
Detecting immunity among doctors, nurses and other healthcare workers could spare them from quarantine and enable them to keep treating the growing surge of coronavirus patients, they say. It could also bolster the ranks of first responders, police officers and other essential workers who have already been infected and have at least some period of protection from the virus, the experts say.
“If I ever get the virus and then get over it, I’ll want to get back to the front lines ASAP,” said Dr. Adams Dudley, a pulmonologist and professor at the University of Minnesota School of Medicine. “I would have a period in which I am immune, effectively making me a ‘corona blocker’ who couldn’t pass the disease on.”
‘VERY ATTRACTIVE’
Other workers sidelined by lockdowns also could potentially return to their jobs, providing a much-needed boost to the foundering U.S. economy. The number of Americans filing for unemployment benefits has soared, and business activity slumped to a record low this month as the pandemic battered the manufacturing and service sectors.
Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, said companies, schools, colleges and professional sports teams could all flock to these tests. He also said a broad sample of testing could give a governor or mayor enough confidence to lift certain restrictions on businesses and schools if there is a strong level of immunity.
“These tests would be very attractive if they’re cost effective, readily available and easy to do,” he said.
Tony Mazzulli, chief microbiologist with Toronto’s Sinai Health system, sounded a note of caution. It is uncertain whether antibodies would be sufficient protection if a person were to be re-exposed to the virus in very large amounts. That could happen in an emergency room or intensive-care unit, for instance.
The timing of a return to work and normal life also matters, he said. Some people who have antibodies to the virus could still be contagious, even if their symptoms have eased. Patients begin to make antibodies while they are still sick, Mazzulli said, and they continue to shed the virus for a few days after they have recovered.
It would be “a bit premature” to use the tests to make staffing decisions now, Mazzulli said. “The hope is … (antibodies) do confer protection and they can go to work, ride the subways, whatever they do. But there’s no guarantee.”
Meantime, at the Mayo Clinic in Rochester, Minnesota, researchers are preparing to start a clinical trial in which patients who test positive for COVID-19 would have their blood collected at the time of diagnosis, and again 15 to 20 days after that in the patient’s home.