Direct Molecular Detection of Pathogens in Blood as Specific Rule-In Diagnostic Biomarker in Patients With Presumed Sepsis

Abstract

The practical value of blood cultures in the diagnosis of sepsis is impaired by a delay in the turnaround time to result and by the fact that blood culture positive can be found for only about 30% of these patients. Conventional laboratory signs of sepsis and acute phase protein biomarkers are sensitive and easy to use, but often also very nonspecific. Molecular diagnostic reflects currently the most promising avenue to decrease time to result and to influence decision making for antibiotic therapy in the septic host. In this study, we wish to highlight the impact of the LightCycler SeptiFast, a multipathogen probe-based real-time polymerase chain reaction, in the rapid etiological diagnosis of sepsis in patients with clinical and laboratory signs of bloodstream infections. We have evaluated prospectively 830 adult patients with suspected bloodstream infection and at least two criteria of systemic inflammatory response syndrome. In more than 50% of critically ill patients strongly suspected of having sepsis, we arrived to an etiological diagnosis only by the molecular method in a median time of 15 h, with specificity and predictive positive values of 96% and 94%, respectively. We highlight the role of DNAemia as time-critical, high-specificity, etiological, non-culture-based rule-in diagnostic biomarker in patients with presumed sepsis.

Sepsis: the LightCycler SeptiFast Test MGRADE®, SepsiTest™ and IRIDICA BAC BSI assay for rapidly identifying bloodstream bacteria and fungi – a systematic review and economic evaluation

“…45,69,[71][72][73][74][75][76][77][78][80][81][82][83][85][86][87][90][91][92][93][94][96][97][98][99][101][102][103]107,[109][110][111][112]114 Of these, nine studies reported blood volumes that did not comply with CE approval: Lehmann et al, 76 Lodes et al 92 and von Lilienfeld-Toal et al 71 all reported using 1 ml in adults; Bloos et al, 74 Lamoth et al, 75 Paolucci et al 99 and Sitnik et al 107 all reported using 3 ml in adults; Berger et al…”

“…Twenty-one SeptiFast studies reported data on the time to availability of results/pathogen identification. [44][45][46]59,60,64,68,69,77,80,81,85,88,93,96,97,101,106,107,110,112 However, for the majority of these studies, it was unclear if the value was the mean or median, and variance estimates or ranges were not reported. Across these studies, the reported time to pathogen identification with SeptiFast ranged from 4 hours 68 to a median of 26.25 hours [range 6.75-79 hours (for samples collected at beginning of a weekend)].…”

Performance and economic evaluation of the molecular detection of pathogens for patients with severe infections: the EVAMICA open-label, cluster-randomised, interventional crossover trial

“…Meta-analyses for testing molecular detection of pathogen in the blood have reported these tests as less sensitive and less specific than BCs, taken as the gold standard, and consequently these tests are rarely used in the diagnostic standard workup [19, 20]. It should be noted that in the previous studies, many cases were shown with positive molecular tests and BC-negative with clinical status showing signs of bloodstream infections [21, 22]. The cost-effectiveness of molecular direct testing in blood remains unknown [23].…”

Periorbital Cellulitis that Developed after Alternative Medication of Hirudo Medicinalis Application

“…They are found primarily in fresh and brackish water. They can cause infections ranges from mild cellulitis to ecthyma gangrenosum and even sepsis in immunocompromised patients [6].…”