ONE TEST FROM ONE WHOLE BLOOD SAMPLE

Here’s what the Power of One means for patients, healthcare providers and laboratorians: 

  • Actionable results in less than one hour
  • Quick test set-up time, with less than two minutes of hands on time
  • Ready to use cartridges with no assembly; room temperature storage
  • Direct from whole blood sample with no tube decapping required

THE POWER OF ONE WITH QVELLA FAST-ID™ BSI PANEL*

A transformative product that identifies over 90% of the pathogens causing bloodstream infections in less than one hour, with the goal of facilitating tailored empiric antimicrobial therapy much faster in critically ill patients.

The system is designed for:

  • ONE test
  • ONE blood sample
  • ONE cartridge
  • ONE instrument to detect the infecting pathogens in less than... 
  • ONE hour.
 
FAST-ID BSI

ONE CARTRIDGE

FAST-Technology™ enables rapid and integrated sample preparation

  • Aspiration from whole blood sample tube simplifies set-up, minimizing contamination
  • Intact pathogen recovery integrated with e-lysis™ yields PCR ready lysate, no multi-step extractions
  • Detects rRNA targets in over 90% of pathogens causing bloodstream infections
  • Room temperature storage with no cartridge assembly
FAST-ID BSI

ONE INSTRUMENT

Redefining RapidTM with real time actionable results directly from whole blood

  • Fully-automated, on demand testing in less than 60 minutes
  • 3-step set-up with less than 2 minutes of hands on time
  • rRNA detection from intact pathogens for maximum sensitivity
  • Real time actionable results with Bi-directional LIS interface
FAST-ID BSI

FAST-ID™ BSI Panel Workflow

Simplified assay set-up design with less than 2 minutes hands on time

  • No additional reagents
  • Room temperature storage of cartridges
  • Closed primary tube sampling
  • Walk-away instrument

How It Works

Processing takes place in a matter of minutes

Pathogen Cell Isolation and Concentration

  • Sealed vaccutainer whole blood sample
  • Blood cells selectively lysed and debris removed
  • Pathogen cells isolated and concentrated from whole blood sample

In-line, Automated Pathogen Cell Lysis, Amplification and Detection

  • In-line e-lysis™ preserves nucleic acids and denatures inhibitors
  • PCR-ready lysate is amplified for rRNA targets optimizing sensitivity
  • 20 well array includes control and reaction wells

Results Available in Less than 60 Minutes

  • Detects over 90% of pathogens causing bloodstream infections
  • Bi-directional LIS interface
  • Optional local printer for immediate availability of results

Comprehensive Pathogen Detection and Identification Directly From Whole Blood in Minutes

Qvella’s transformative FAST-TechnologyTM, in the FAST-ID BSI Panel is designed to deliver the unique ability to isolate and detect intact pathogens directly from a whole blood sample, providing identification of a wide range of pathogens causing BSI.

  • rRNA target detection is designed for optimal sensitivity and specificity
  • Designed to detect over 90% of sepsis causing bacteria and candida pathogens
  • Identifies problematic species with challenging antibiotic resistance profiles

Actionable Results that can Meaningfully Impact Treatment Decisions

FAST-ID BSI

FAST Answers for Initial Therapy Decisions and Antimicrobial Stewardship

  • Identifying infecting pathogens in BSI takes up to 5 days plus an additional 1+ day to AST
  • This renders the earliest time for data-driven targeted (appropriate or optimal in the literature) antimicrobial therapy to 3 to 6 days
  • The FAST-Technology™ BSI Panel is designed with the aim to deliver critical results to the clinical and stewardship teams to assist in defining the most appropriate antimicrobial therapies at the time of diagnosis.
*FAST-ID™ is under development and not approved for sale. The performance characteristics have not been established.