Abstract
BackgroundThe immediate need for appropriate antimicrobial therapy in septic patients requires the detection of the causative pathogen in a timely and reliable manner. In this study, the real-time PCR Septifast MGrade test was evaluated in adult patients meeting the systemic inflammatory response syndrome (SIRS) criteria that were treated at standard care wards.MethodsPatients with clinical suspected infection, drawn blood cultures (BC), the Septifast MGrade test (SF) and sepsis biomarkers were prospectively screened for fulfillment of SIRS criteria and evaluated using the criteria of the European Centre of Disease Control (ECDC) for infection point prevalence studies.ResultsIn total, 220 patients with SIRS were prospectively enrolled, including 56 patients with detection of bacteria in the blood (incidence: 25.5%). BC analysis resulted in 75.0% sensitivity (95% confidence interval, CI: 61.6%– 85.6%) with 97.6% specificity (CI: 93.9%– 99.3%) for detecting bacteria in the blood. In comparison to BC, SF presented with 80.4% sensitivity (CI: 67.6%– 89.8%) and with 97.6% specificity (CI: 93.9%– 99.3%). BC and SF analysis yielded comparable ROC-AUCs (0.86, 0.89), which did not differ significantly (p = 0.558). A trend of a shorter time-to-positivity of BC analysis was not seen in bacteremic patients with a positive SF test than those with a negative test result. Sepsis biomarkers, including PCT, IL-6 or CRP, did not help to explain discordant test results for BC and SF.ConclusionSince negative results do not exclude bacteremia, the Septifast MGrade test is not suited to replacing BC, but it is a valuable tool with which to complement BC for faster detection of pathogens.
Highlights
Sepsis is a frequent and severe condition with a high mortality rate [1]
The realtime PCR Septifast MGrade test was evaluated in adult patients meeting the systemic inflammatory response syndrome (SIRS) criteria that were treated at standard care wards
Patients with clinical suspected infection, drawn blood cultures (BC), the Septifast MGrade test (SF) and sepsis biomarkers were prospectively screened for fulfillment of SIRS criteria and evaluated using the criteria of the European Centre of Disease Control (ECDC) for infection point prevalence studies
Summary
Sepsis is a frequent and severe condition with a high mortality rate [1]. Rapid identification of septic patients is of major importance for their survival, since they immediately need appropriate antimicrobial therapy [2]. A median time to a positive report of three days is necessary to detect pathogens [5, 6]. In this period of time, patients are treated with an empiric antimicrobial therapy, using broad spectrum antibiotics, which often do not appropriately cover the causative pathogens [7]. Unnecessary medication with broad spectrum antibiotics is associated with the emergence of multidrug-resistant pathogens, a higher rate of adverse drug effects as well as higher overall costs [8, 9]. The immediate need for appropriate antimicrobial therapy in septic patients requires the detection of the causative pathogen in a timely and reliable manner. The realtime PCR Septifast MGrade test was evaluated in adult patients meeting the systemic inflammatory response syndrome (SIRS) criteria that were treated at standard care wards
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