The new iteration of the test is cleared for use with whole blood from living patients and cadaveric oral fluid from individuals suspected of carrying the virus at the time of death. Compared to the company’s first-generation test, which received FDA authorization in 2019, this version utilizes updated chemistry and an automated manufacturing process to enhance diagnostic accuracy.
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FDA Clears OraSure’s Enhanced Rapid Ebola Test
The Food and Drug Administration has granted emergency use authorization to OraSure Technologies for its OraQuick Ebola 2.0 Rapid Antigen Test. This upgraded diagnostic tool offers improved sensitivity for detecting all four known human-pathogenic ebola viruses, providing a critical instrument for containment efforts in the ongoing central African outbreak.
Chief Executive Carrie Eglinton Manner emphasized that the current outbreak is particularly dangerous due to the presence of the Bundibugyo virus, for which no vaccine or targeted treatment currently exists. By enabling faster, more reliable detection, the company aims to support public health officials in curbing the spread of the virus in high-risk regions.
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