Accuracy of Abbott's COVID-19 Test Called into Question, an Industrial Info Market Brief

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As COVID-19 continues to drive up need for accurate diagnostics, treatments and a vaccine, the U.S. Food & Drug Administration (FDA) has been granting emergency approvals on products that have not undergone the typical rigorous testing process. In use at the White House, some recent studies are finding Abbott's ID NOW test missed 48% of positive cases. The test was prized for its rapid five-minute turnaround time, rather than waiting hours, days and in some cases, weeks for results.

Abbott disagrees with the mounting studies, particularly one by New York University (NYU). More studies are called for, while other manufacturers race to produce viable tests, both for the diagnosis of active COVID-19, as well as those for testing for virus antibodies. In the meantime, the American Medical Association (AMA) is warning the public on the limitations of serological (antibody) testing and has warned that "physicians and the public cannot assume that, if antibodies are found, that they confer immunity to COVID-19," and the AMA "warns that public health decisions, such as discontinuation of physical distancing, should not be made on the basis of results."