Home 5 Articles 5 Now Even the “Good” Tests Are Coming Under Fire

Now Even the “Good” Tests Are Coming Under Fire

by | May 26, 2020 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Emerging Tests-dtet, FDA-dtet

The inaccuracy of serology tests that detect antibodies to the SARS-CoV-2 virus has become an issue of mounting concern. Even though the lack of sensitivity and specificity of these tests is well documented, the vast majority of the more than 150 SARS-CoV-2 serology tests currently provided in the U.S. reached the market through a pathway that did not require Food and Drug Administration (FDA) review. The supposed silver lining is the group of 11 tests that did actually receive Emergency Use Authorization (EUA) clearance and are thus deemed the most reliable. However, a new study casts suggests that one of the fastest and most widely used of these gold standard tests has major sensitivity problems, missing as many as half of the cases that another test found to be positive. The NYU Study Researchers from New York University (NYU) set out to evaluate one of the newly approved SARS-CoV-2 serology tests used in their laboratories. While those tests also included the Cepheid Xpert Xpress and Roche Cobas assay, Abbott Laboratories’ ID Now point of care test was an attractive target for study because of its fast turnaround—the Abbott test produced results in as little as five minutes, as compared to […]

Subscribe to Clinical Diagnostics Insider to view

Start a Free Trial for immediate access to this article