United States FDAs emergency use authorization of Ebola virus diagnostics: Current impact and lessons for the future

Expert Review of Molecular Diagnostics

Volumn 15, Issue 10, 2015, Pages 1231-1235

  Whitehouse, Chris A ^a   Bavari, Sina ^a   Perkins, Mark D ^b  

^a UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES   (United States)

^b FOUNDATION FOR INNOVATIVE NEW DIAGNOSTICS   (Switzerland)

Author keywords

assays; diagnostics; Ebola; filoviruses; regulation; viral outbreaks

Indexed keywords

PROTEIN VP40;

CHEMILUMINESCENCE IMMUNOASSAY; CHEMILUMINESCENCE IMMUNOASSAY KIT; CONTACT EXAMINATION; DIAGNOSTIC TEST ACCURACY STUDY; EBOLA HEMORRHAGIC FEVER; EBOLAVIRUS; EMERGENCY CARE; ENZYME LINKED IMMUNOSORBENT ASSAY; EPIDEMIC; EPSILOMETER TEST; FOOD AND DRUG ADMINISTRATION; FUTUROLOGY; HUMAN; IN VITRO STUDY; LAW; MEDICAL DECISION MAKING; MOLECULAR DIAGNOSTICS; NONHUMAN; POLYMERASE CHAIN REACTION SYSTEM; PREDICTIVE VALUE; RAPID TEST; REAL TIME POLYMERASE CHAIN REACTION; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; REVIEW; SENSITIVITY AND SPECIFICITY; UNITED STATES; VIRUS DIAGNOSIS; VIRUS ISOLATION; AFRICA; DIAGNOSTIC TEST APPROVAL; HEMORRHAGIC FEVER, EBOLA; REPRODUCIBILITY;

AFRICA, WESTERN; DIAGNOSTIC TEST APPROVAL; DISEASE OUTBREAKS; HEMORRHAGIC FEVER, EBOLA; HUMANS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84942293611     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/14737159.2015.1077117     Document Type: Review

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