Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA
In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Prospective Study Into the Performance of the KeyPathtm MRSA/MSSA Blood Culture Test - BTA|
- Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
A. Determination of the performance of the KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives by:
i. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex).
ii. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for determination of MRSA and MSSA among S. aureus positives by comparison to the reference method (30 µg cefoxitin disc diffusion).
Biospecimen Retention: Samples Without DNA
Retention of de-identified blood culture specimens only.
|Study Start Date:||June 2012|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Standard of Care
KeyPath Test Group
All specimens collected that meet the inclusion criteria will be tested using the KeyPath BTA Test.
This is a multi-center clinical study to investigate the effectiveness of the performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA. The KeyPath test is performed directly on positive blood culture specimens from bioMerieux BacT/ALERT blood culture bottles. The MicroPhage test will be compared to standards and market available tests with similar indications (comparators). It is estimated that the study will last 3-4 months depending on the accural rate at the institutions.
|United States, Arizona|
|University of Arizona, Infectious Disease Research|
|Tuscon, Arizona, United States, 85721|
|United States, California|
|UCLA Clinical Laboratory|
|Los Angeles, California, United States, 90049|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Dipankar Manna, Ph.D.||MicroPhage, Inc.|