Could a rapid diagnostic test to identify Ebola have prevented the first cases of Ebola transmission in the United States? While it is too late to know for sure, diagnostics manufacturers, federal U.S. defense and health agencies, and regulatory bodies are aggressively working to leverage their current assets to help contain the global epidemic. While Thomas Eric Duncan’s travel history was a missed opportunity to provide earlier isolation and care, administrators at Texas Health Presbyterian Hospital in Dallas say that the lack of an accurate, rapid diagnostic hampered efforts to detect and diagnose the virus. The current gold standard for Ebola diagnosis relies upon polymerase chain reaction (PCR) testing. There are currently no U.S. Food and Drug Administration-approved or -cleared tests for Ebola, but the FDA, as of Nov. 1, has given emergency authorization for use of five Ebola tests. The most recent emergency approvals were two assays developed by BioFire Defense (Salt Lake City; a BioMérieux company). The company’s one-hour FilmArray Biothreat-E test is now cleared for emergency commercial use, as is a second assay (FilmArray NGDS BT-E Assay) that can be used only by laboratories designated by the Department of Defense (DOD). “It would have taken years to […]