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Flow cytometry and Advanced FASTinov Algorithms

FASTinov patented methodology is based on an early detection of microbial cell lesions or metabolic changes, relying on a proprietary combination of particular fluorescent probes that target specific changes and make these identifiable through flow cytometry. The technology has been optimized such that no flow cytometry knowledge is needed to perform FASTinov AST.

Advanced proprietary FASTinov computation then interprets the complex cytometry information and classifies bacterial cells in terms of their susceptibility phenotype in a growth independent manner.

“The FASTinov technology is truly disruptive. It has the potential to transform infection management and antibiotic policy globally.”

See the world’s fastest antibiogram in action

Fastest workflow for bloodstream bacterial infection

Ultra FAST AST workflows require AST to start as soon as blood cultures flag positive.

Once blood cultures flag positive, the semi-automated FASTinov AST can start. The sample preparation requires 10 min for any set of Blood Cultures, after which the lab technician is only intermittently required for few minutes.

The FASTinov AST report is generated within 2 hours, at any time of the day, because it does not require batch processing. There is no waiting for new positive blood cultures to finally start AST.

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Evidence / validation

FASTinov AST was validated with high categorical agreement compared to the reference method*, using more than 2,500 samples, with both the EUCAST and CLSI protocols.

Key results – EUCAST protocol


  
Categorial agreement
 
Very major errors
 
Reproducibility
FASTgrampos AST
 
97.8%
 
0.4%
 
99.4%
FASTgramneg AST
 
98.9%
 
0.9%
 
99.5%
FASTcolistin MIC
 
98.8%
 
1.2%
 
97.0%

Key results – CLSI protocol



 
Categorial agreement
 
Very major errors
 
Reproducibility
FASTgrampos AST
 
97.9%
 
0.3%
 
99.8%
FASTgramneg AST
 
97.9%
 
0.7%
 
99.3%
FASTcolistin MIC
 
94.9%
 
1.2%
 
97.0%

Detection of mechanisms of resistance

The FASTgramneg kit allows the detection of some mechanisms of resistance like ESBL presence, and the screening of AmpC and carbapenemases.


  
Sensitivity
 
Specificity
 
Accuracy
ESBL (EB group I)
 
95,7%
 
100%
 
99,3%
ESBL (EB group II)
 
100%
 
100%
 
100%
pAmpC
 
100%
 
100%
 
100%
Carbapenemases
 
92,2%
 
95,1%
 
94,1%

* IFU, data on file

Broad antibiotic panel

Because FASTinov’s technology is phenotypic and growth independent, an antibiogram is delivery in up to 2h regardless of the species and keeping state of the art accuracy. Validated for a broad combination of bacterial strains and 19 antibiotics:

  • Amikacin
  • Amoxacillin-clavulanic acid
  • Ampicillin
  • Cefepime
  • Cefotaxime
  • Cefoxitin
  • Ceftalozane-tazobactam
  • Ceftazidime
  • Ceftazidime-avibactam
  • Ciprofloxacin
  • Colistin
  • Gentamicin
  • Imipenem
  • Linezolid
  • Meropenem
  • Oxacillin
  • Penicillin
  • Piperacillin-tazobactam
  • Vancomycin

Publications

The FASTinov technology is the result of 9 years of cutting-edge research

Antimicrobial susceptibility testing directly from positive blood cultures. 2021.

Journal of Clinical Microbiology 4:JCM0054421

Ultra-rapid flow cytometry assay for colistin MIC determination in Enterobacterales, Pseudomonas aeruginosa and Acinetobacter baumannii, 2020.

Clinical microbiology and infection, vol. 26,11 (2020): 1559.e1-1559.e4.

Evaluation of ultra-rapid susceptibility testing of ceftolozane-tazobactam by a flow cytometry assay directly from positive blood cultures, 2020.

European Journal of Clinical Microbiology & Infectious Diseases, 39, 1907–1914.

A Rapid Flow Cytometric Antimicrobial Susceptibility Assay (FASTvet) for Veterinary Use – Preliminary Data, 2020.

Frontiers in Microbiology. 11:1944

Evaluation of rapid colistin susceptibility directly from positive blood cultures using a flow cytometry assay, 2019.

International Journal of Antimicrobials Agents. Volume 54, Issue 6, December 2019, Pages 820-823

Flow Cytometry in Microbiology: The Reason and the Need. 2017

Single Cell Analysis. Singapore; Springer 155-169

Potential Impact of Flow Cytometry Antimicrobial Susceptibility Testing on the Clinical management of Gram-Negative Bacteremia Using the FASTinov® Kit, 2017.

Frontiers in Microbiology. Dec 12;8:2455

Rapid flow cytometry test for identification of different carbapenemases in Enterobacteriaceae. 2016

Antimicrob Agents Chemother. 2016 Mar 28. pii: AAC.02947-15.

Clinical and economical impact of a rapid susceptibility testing regarding blood cultures with Gram negative bacilli. 2016

26th ECCMID, Amsterdam, Netherlands, 2016.

Rapid antimicrobial susceptibility profile directly from positive blood cultures using flow cytometry. 2015

25th ECCMID, Copenhagen, Denmark, 2015.

Rapid detection of extended-spectrum b-lactamase producing bacteria by means of flow cytometry. 2013

Clin Microbiol Infect. 2013 Jan;19(1):E8-E15.

A rapid flow cytometry test for detection of vancomycin and linezolid-resistance among Gram-positive bacteria. 23th ECCMID, Berlin, Germany, 2013.

Patents

  • Kit and method of detecting the resistant microorganisms to a therapeutic agent. WO/2012/164547 A1. Granted in Europe
  • Fluorescent method of detecting microorganisms resistant to a therapeutic agent. US14123757. Granted in USA. Same patent family granted in Japan, Brazil and India.
  • Improved therapeutic drug monitoring. Application No: EP 18737735.3. Granted in Europe.
  • FASTgramneg/FASTgrampos product patent application filled Feb 2022