According to an article appearing in the November issue of the Army’s publication called “Mercury”, http://armymedicine.mil, the U.S Army Medical Research Institute of Infectious Diseases www.usamriid.army.mil is at the forefront to develop a lab test or assay to diagnose Ebola in the U.S.
The assay that detects the Zaire strain of Ebola virus in patient samples is called the “Ebola Zaire Real-Time PCR Assay Test Kit” was developed, manufactured, and tested with help from the Army Medical Materiel Development Activity www.usa.mmda.aarmy.mil.
The test has not yet been approved by FDA, but the FDA has authorized its use under an “Emergency Use Authorization” (EUA) granted last August. EUA provides a legal basis for the use of unapproved medical products, including diagnostics in a declared emergency when there are not alternatives.
The test is available at authorized DOD labs in the U.S and overseas, as well as selected CDC Laboratory Response Network www.bt.cdc.gov/lrn state public health labs throughout the country.
So far, according to David A. Norwood, PhD, Chief of USAMRIID’s Diagnostic Systems Division, “The assay is also being used in West Africa for the rapid diagnosis of host nation patients.
He further explains, “There is no disparity between the diagnostic capabilities that are being used in that country and those that are available for testing U.S. citizens. While the labeling and execution is somewhat different for regulatory purposes for testing U.S citizens, the same capability is available for diagnostic testing for everyone.”