Demonstration of the Pre–Emergency Use Authorization Path Using 3 Minor Groove Binder–Hydrolysis Probe Assays to Detect Escherichia coli O104:H4
| Autor: | Ashley M. Zovanyi, Megan L. Heinrich, J. Jaissle, David A. Norwood, Timothy D. Minogue, Michael F. Ingram, David A. Kulesh, Laurie J. Hartman, J. Peyton Hobson, Philip D. Craw |
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| Rok vydání: | 2015 |
| Předmět: |
DNA
Bacterial Emergency Use Authorization Clinical Biochemistry Pcr assay Biology Real-Time Polymerase Chain Reaction In vitro diagnostic Disease Outbreaks Food and drug administration Escherichia coli O104:H4 Limit of Detection Escherichia coli Humans Escherichia coli Infections United States Food and Drug Administration Escherichia coli Proteins Hydrolysis Biochemistry (medical) Authorization Sequence Analysis DNA Galactosyltransferases Virology United States Fimbriae Proteins Flagellin Minor groove Clearance |
| Zdroj: | Clinical Chemistry. 61:1391-1398 |
| ISSN: | 1530-8561 0009-9147 |
| Popis: | BACKGROUNDThe Department of Defense (DoD) and the Food and Drug Administration (FDA) have collaboratively worked on a pre–Emergency Use Authorization (pre-EUA) process for in vitro diagnostic (IVD) devices, using FDA's regulatory flexibilities under the EUA authorities. The pre-EUA process enables FDA review of data in anticipation of a request for an EUA, advancing US government public health emergency preparedness efforts.METHODSThe IVD device developed to detect Escherichia coli O104:H4, for which an EUA has not been issued, serves as an example to illustrate that process. Specifically, DoD designed real-time PCR assays to target the virulent E. coli strain O104:H4 (etiological agent of the 2011 German outbreak) including: fliC (flagellin), Agg3C (AAF), and rfb (wbwC) on the basis of the published sequences.RESULTSAfter development and optimization of these 3 specific assays, a defined protocol was followed to determine and document the sensitivity and specificity of each assay analytically.CONCLUSIONSFDA reviewed these data and returned commentary on additional required experiments to complete the pre-EUA process and expedite the use of the device should there be an emergency need for an IVD device to detect this virulent E. coli strain before such a test is cleared by FDA. |
| Databáze: | OpenAIRE |
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