NCT02719769

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

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT02719769

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

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

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.

Eligibility

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

Disease(s) and\or Condition(s)

Bacteremia

Fungemia

Primary Purpose

Intervention/Treatment

Sponsor

Accelerate Diagnostics, Inc.