Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture
Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture
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.
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.
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