Abstract
BackgroundEarly diagnosis and rapid bacterial identification are of primary importance for outcome of septic patients. SeptiFast® (SF) real-time PCR assay is of potential utility in the etiological diagnosis of sepsis, but it cannot replace blood culture (BC) for routine use in clinical laboratory. Procalcitonin (PCT) is a marker of sepsis and can predict bacteremia in septic patients. The aim of the present study was to investigate whether PCT serum levels could predict SF results, and could help screening febrile patients in which a SF assay can improve the etiological diagnosis of sepsis.MethodsFrom 1009 febrile patients with suspected sepsis, 1009 samples for BC, SF real-time PCR, and PCT determination were obtained simultaneously, and results were compared and statistically analysed. Receiver operating characteristic (ROC) curves were generated to determine the area under the curve and to identify which cut-off of PCT value produced the best sensitivity to detect SF results.ResultsMean PCT values of sera drawn simultaneously with samples SF positive (35.42±61.03 ng/ml) or BC positive (23.14±51.56 ng/ml) for a pathogen were statistically higher than those drawn simultaneously with SF negative (0.84±1.67 ng/ml) or BC negative (2.79±16.64 ng/ml) samples (p<0.0001). For SF, ROC analysis showed an area under the curve of 0.927 (95% confidence interval: 0.899–0.955, p<0.0001). The PCT cut-off value of 0.37 ng/ml showed a negative predictive value of 99%, reducing the number of SF assays of 53.9%, still identifying the 96.4% of the pathogens.ConclusionPCT can be used in febrile patients with suspected sepsis to predict SF positive or negative results. A cut-off value of 0.37 ng/ml can be considered for optimal sensitivity, so that, in the routine laboratory activity, SF assay should not be used for diagnosis of sepsis in an unselected patient population with a PCT value <0.37 ng/ml.
Highlights
Sepsis is a major threat to life [1]
Procalcitonin test, SF real-time PCR, and blood culture (BC) were performed in samples collected simultaneously from 1009 patients from January 2011 to March 2012
Nine hundred and sixteen (90.8%) patients were hospitalized in Medical wards, 75 (7.4%) patients in Surgical wards, and 18 (1.8%) patients in Intensive Care Units (ICUs)
Summary
Sepsis is a major threat to life [1]. Early diagnosis and rapid bacterial identification are of primary importance for a correct clinical management and initiation of effective antimicrobial therapy [2,3,4].Blood culture (BC) is considered the gold standard for detection of pathogens from patients with sepsis, but it remains insufficiently time critical and cannot assist with early therapeutic decisions [5].Molecular assays are of potential utility in improving the diagnosis of sepsis. SeptiFastH (SF), a multi-pathogen probe-based real-time PCR system targeting DNA sequences of bacteria and fungi present in blood samples [6], has been intensively investigated in clinical studies and is considered a valuable complementary tool in the management of patients with suspected sepsis [7,8,9]. It provides information not entirely interchangeable with BC and it is not superior to BC for pathogen identification, in an unselected patient population with suspected sepsis [10]. The aim of the present study was to investigate whether PCT serum levels could predict SF results, and could help screening febrile patients in which a SF assay can improve the etiological diagnosis of sepsis
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