Pre-Clinical Testing of a Real-Time PCR Assay for Diahhreal Disease Agent Cryptosporidium
Abstract
Pre-clinical test results qualify the Cryptosporidium real-time PCR assay as a lead candidate 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, a Cryptosporidium spp Detection Kit pre-IDE document was 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.
Document Details
- Document Type
- Technical Report
- Publication Date
- May 16, 2014
- Accession Number
- ADA600722
Entities
People
- Carl J. Mason
- James C. Mcavin
Organizations
- 59th Medical Wing