Evaluation of the Sepsis Flow Chip assay for the diagnosis of blood infections

Abstract

BackgroundBlood infections are serious complex conditions that generally require rapid diagnosis and treatment. The big challenge is to reduce the time necessary to make a diagnosis with current clinical microbiological methods so as to improve the treatment given to patients.MethodsIn this study, we assess for the first time the Sepsis Flow Chip assay, which is a novel diagnostic assay for simultaneous rapid-detection of the vast majority of bloodstream pathogens, including Gram-positive and Gram-negative bacteria and fungi, in the same assay, and for the detection of most common antibiotic resistance genes. The SFC assay is based on multiplex PCR and low density DNA arrays.ResultsPositive blood cultures from 202 consecutive bacteremia patients were analyzed by SFC assay and the results were compared with the results obtained by the gold standard methodology used in clinical microbiology diagnostic laboratories (EUCAST guidelines). SFC assay overall sensitivity and specificity for bacterial identification were 93.3% and 100% respectively and sensitivity and specificity for the identification of antibiotic genetic resistance determinants were 93.6% and 100% respectively.ConclusionsThis is the first evaluation of SFC assay in clinical samples. This new method appears to be very promising by combining the high number of distinct pathogens and genetic resistance determinants identified in a single assay. Further investigations should be done to evaluate the usefulness of this assay in combination with clinical multidisciplinary groups (stewardship), in order for the results to be applied appropriately to the management of patients`infectious processes.

Diagnosis of bloodstream infections from positive blood cultures and directly from blood samples: recent developments in molecular approaches

“…Sepsis Flow Chip (Master Diagn ostica, Granada, Spain) is a novel CE labelled diagnostic assay, able to detect most of the pathogens causing BSIs and their resistance markers based on a multiplex PCR, followed by reverse dot blot hybridization [39]. Sepsis Flow Chip allows simultaneous detection of over 36 bacterial species, Candida spp.…”

“…and 20 antimicrobial resistance markers within 3 hours [40]. The clinical evaluation study of the Sepsis Flow Chip yielded promising results with an overall sensitivity and specificity of 93.3% and 100%, respectively, for bacterial identification, and 93.6% and 100%, respectively, for the detection of the antimicrobial resistance determinants [39]. In this validation study, a 96.2% and 89.1% concordance with standard microbiological diagnostic protocols was shown in monomicrobial and polymicrobial cultures, respectively [39].…”

Molecular Methods for the Diagnosis of Invasive Candidiasis

“…This is achieved by the use of biotinylated primers, automated reverse hybridization to a chip membrane and subsequent immunoenzymatic detection of positive signals. In the first evaluation on clinical samples [ 46 ], six yeast-positive BC were included. Five of these contained C. albicans , and all were detected by the test.…”

Impact of Sepsis Flow Chip, a novelty fast microbiology method, in the treatment of bacteremia caused by Gram-negative bacilli

“…Impact of Sepsis Flow Chip, a novelty fast microbiology method, in the treatment of bacteremia caused by Gram-negative bacilli identification [6]. However, the impact of SFC results on the management of BGN-BSI has not been analyzed yet, due to this system has been recent commercialized.…”