A new antibody test has been found to be highly effective in assessing if individuals were infected with the novel coronavirus, according to a report published on Friday in The Journal of Clinical Microbiology.
The test, produced by Abbott Laboratories, was found by researchers at the University of Washington School of Medicine to have a specificity rate of 99.9 percent and a sensitivity rate of 100 percent, indicating very little risk of diagnosing a healthy person as infected and virtually no possibility of a false negative reading.
Abbott Lab's test has earned the approval of the Food and Drug Administration for emergency use, and the company has now delivered over 10 million samples to hospitals and laboratories.
Proving test reliability and obtaining approval stamps from regulatory agencies has become an important matter concerning coronavirus antibody testing which public officials typically find to be valuable tools for reopening their economies after the first wave of the pandemic.
The tests will provide information into the percentage of the population that has been contaminated, healed, and possibly acquired some immunity - but only if they are reliable.
Precision issues, including from the American Medical Association, prompted the FDA to tighten its regulation of antibody testing early this week.
Researchers at the UWSM have found that the newly released blood test for SARS-CoV-2 antibodies by Abbott Laboratories is extremely effective in the identification of antibodies in patients examined at least 17 days after symptom onset.
The analysis was carried out in Boise, Idaho as part of an effort, funded by local companies, called "Crush the Curve." The researchers tested 1,020 blood samples obtained before the launch of COVID-19 in the U.S., and found one false positive.
They also tested 689 blood samples from 125 patients who were reported to have COVID-19, and those tests returned 100 per cent of the time positive results.
The Abbott research was conducted in the United States last month under the loose guidelines for certain coronavirus studies by the Food and Drug Administration allowing for their delivery before regulatory approval. The study has since obtained FDA authorization for emergency use.
Health systems will play a crucial part in large-scale clinical trials and partnership with leaders like the University of Washington will help to guarantee that tests being made Abbott are "performing at the highest standards when they are used in real-world settings," Abbott chief executive officer Robert B. Ford said in a media release.
