Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Accelerate Diagnostics, Inc.
- Enrollment
- 4,009
- Locations
- 14
- Primary Endpoint
- Comparison Study - ID Performance
Study Overview
Brief Summary
The "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing" is designed to validate the clinical performance of the Accelerate ID/AST System for positive blood culture identification and susceptibility testing in a clinical setting. The data from this study will be used to support the 510(k) submission for FDA clearance and global registrations of the device intended for in vitro diagnostic use.
Detailed Description
The clinical study entitled "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing" is designed to demonstrate the clinical performance of the Accelerate ID/AST System for positive blood culture identification (ID) and antimicrobial susceptibility testing (AST) in a clinical setting compared to reference results. Approximately 3,000 positive blood culture samples (across all Clinical Sites) will be tested on the investigational device and reference methods. Up to 50% of samples enrolled will be comprised of seeded blood cultures prepared from clinical stock isolates. Quality Control testing will be performed each day of testing. The study population is comprised of left-over clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories. Positive blood culture samples must be tested on the Accelerate ID/AST System within 8 hours of positivity by the blood culture monitoring system. Testing of clinical samples will continue until the required sample size for each target organism and antimicrobial agent, including sufficient on-scale and resistant strains, are tested across all the sites.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •De-identified positive blood culture specimens (6 mL aliquot)
- •Seeded blood culture specimens (stock) from archived bacterial and yeast isolates
Exclusion Criteria
- •Sample volume available < 6 mL
- •Positive Blood Culture sample > 8 hours post-positivity
- •Sample from patient previously enrolled
- •Sample from blood culture media that contain charcoal e.g., BACTAlert FA, FN bottles
- •Samples from Mycobacterial-type blood culture media e.g., BACTEC Myco/F Lytic, BacT/ALERT MP Bottle, VersaTREK Myco
Outcomes
Primary Outcomes
Comparison Study - ID Performance
Time Frame: Approximately 9 months (including pre-clinical phase)
Positive and Negative Percent Agreement with Comparator Method (Vitek2) by Bacterial/Fungal Target
Secondary Outcomes
- Comparison Study - AST Performance(Approximately 9 months (including pre-clinical phase))