FAST-ID BSI

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.

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

ONE INSTRUMENT

Redefining Rapid^TM 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 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-Technology^TM, 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

The critical difference for septic patients

Earlier tailored antimicrobial therapy saves lives¹
SSC¹ and NICE² recommend initiation of antimicrobial therapy within one hour of diagnosis
The FAST-ID^TM BSI Panel is designed to provide results in minutes vs. hours

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.