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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing

Conditions
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Bacteremia, Fungemia

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison Study - ID Performance | Positive and Negative Percent Agreement with Comparator Method (Vitek2) by Bacterial/Fungal Target | Approximately 9 months (including pre-clinical phase) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison Study - AST Performance | Essential and Categorical Agreement with CLSI Frozen Reference Method (BMD) by Antimicrobial | Approximately 9 months (including pre-clinical phase) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positive Blood Culture