Accession Number : ADA600976


Title :   Pre-Clinical Testing of Real-Time PCR Assays for Diarrheal Disease Agents of Genera Escherichia and Shigella


Descriptive Note : Final rept. 1 Oct 2010-30 Sep 2013


Corporate Author : AIR FORCE MEDICAL WING (59TH) WILFORD HALL AMBULATORY SURGICAL CENTER LACKLAND AFB TX CLINICAL RESEARCH DIV


Personal Author(s) : McAvin, James C ; Mason, Carl J


Full Text : https://apps.dtic.mil/dtic/tr/fulltext/u2/a600976.pdf


Report Date : 16 May 2014


Pagination or Media Count : 39


Abstract : Pre-clinical test results qualify ETEC and Shigella real-time PCR assays as lead candidates for transition to clinical phase testing. Diagnostic sensitivity results were 96% to 100% in testing conducted under laboratory and field conditions. Current commercially available molecular-based diagnostic assay sensitivity is 95% to 98% representing the standard that must be met or exceeded to qualify as a candidate for FDA clearance. In addition to test activities, Enterotoxigenic Escherichia coli Detection Kit and Shigella Detection Kit pre-IDE documents were prepared to serve as a point of departure for discussion with the FDA Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) on guidance and clarification of specific testing requirements for eventual clearance. During the conduct of RDT&E activities a formal GME training program was established by the investigators. The program provides for scholarly and challenging research opportunities in a real-world environment. Under this project, an Air Force resident physician completed research which directly resulted in advancing Force Health Protection diarrheal disease diagnostic technologies toward clearance. Two separate research projects were completed, abstracts prepared, and posters presented at a medical symposium. The resident successfully completed WHAMC Pathology Department Research Elective 144. These projects are described in the Results section. Project activities are provided in Appendix A and course description and requirements are provided in Appendix B.


Descriptors :   *CLINICAL MEDICINE , *DIAGNOSIS(MEDICINE) , *DIARRHEA , *DISEASE VECTORS , *ESCHERICHIA , *IN VITRO ANALYSIS , *SHIGELLA , ENTEROTOXINS , ESCHERICHIA COLI , TEST AND EVALUATION


Subject Categories : Medicine and Medical Research


Distribution Statement : APPROVED FOR PUBLIC RELEASE