Performance of the iFAST System for Rapid Phenotypic AST
Research type
Research Study
Full title
Performance of the iFAST System for Rapid Phenotypic Antimicrobial Susceptibility Testing (AST) of Gram Negative Bacteria directly from Positive Blood Culture Bottles and directly from growth isolated colonies
IRAS ID
348079
Contact name
Allyson Lloyd
Contact email
Sponsor organisation
iFAST Diagnostics Limited
Duration of Study in the UK
0 years, 6 months, 29 days
Research summary
The iFAST Antimicrobial Susceptibility Test (AST) System, manufactured by iFAST Diagnostics based in the UK, is an automated in vitro diagnostic system for quantitative and qualitative AST for most clinically significant Gram-negative aerobic microorganisms direct from positive blood cultures.
The iFAST AST System is intended to be a safe and effective Quantitative and Qualitative test system, and the performance of the iFAST system will be assessed according to the standard ISO 20776-2:2022 Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth microdilution (BMD).
To obtain UKCA Mark approval and to support claims that the system accurately performs both qualitative and quantitative antimicrobial susceptibility testing, the following will be evaluated:
1. The iFAST AST system will be compared with the standard susceptibility methods that are used routinely in 3 typical UK hospital microbiology laboratories.
2. Furthermore, per the ISO 20776-2:2022 standard, the iFAST results will be compared with a Broth Micro Dilution reference method performed by a central reference laboratory
3. The evaluation will also assess the usability of iFAST and confirm its potential for delivering results within 3h of receiving a positive whole blood culture.
REC name
South East Scotland REC 02
REC reference
24/SS/0082
Date of REC Opinion
22 Oct 2024
REC opinion
Favourable Opinion