Diagnostic performance of a multiple real-time PCR assay in patients with suspected sepsis hospitalized in an internal medicine ward.
Early identification of causative pathogen in sepsis patients is pivotal to improve clinical outcome. SeptiFast (SF), a commercially available system for molecular diagnosis of sepsis based on PCR, has been mostly used in patients hospitalized in hematology and intensive care units. We evaluated the diagnostic accuracy and clinical usefulness of SF, compared to blood culture (BC), in 391 patients with suspected sepsis, hospitalized in a department of internal medicine. A causative pathogen was identified in 85 patients (22%). Sixty pathogens were detected by SF and 57 by BC. No significant differences were found between the two methods in the rates of pathogen detection (P = 0.74), even after excluding 9 pathogens which were isolated by BC and were not included in the SF master list (P = 0.096). The combination of SF and BC significantly improved the diagnostic yield in comparison to BC alone (P < 0.001). Compared to BC, SF showed a significantly lower contamination rate (0 versus 19 cases; P < 0.001) with a higher specificity for pathogen identification (1.00, 95% confidence interval [CI] of 0.99 to 1.00, versus 0.94, 95% CI of 0.90 to 0.96; P = 0.005) and a higher positive predictive value (1.00, 95% CI of 1.00 to 0.92%, versus 0.75, 95% CI of 0.63 to 0.83; P = 0.005). In the subgroup of patients (n = 191) who had been receiving antibiotic treatment for ≥24 h, SF identified more pathogens (16 versus 6; P = 0.049) compared to BC. These results suggest that, in patients with suspected sepsis, hospitalized in an internal medicine ward, SF could be a highly valuable adjunct to conventional BC, particularly in patients under antibiotic treatment.
Internal Medicine, Angiology and Arteriosclerosis Diseases Section, Department of Clinical and Experimental Medicine, University of Perugia, Perugia, Italy.
Leonella
L
Pasqualini
Antonella
A
Mencacci
Christian
C
Leli
Paolo
P
Montagna
Angela
A
Cardaccia
Elio
E
Cenci
Ines
I
Montecarlo
Matteo
M
Pirro
Francesco
F
di Filippo
Emma
E
Cistaro
Giuseppe
G
Schillaci
Francesco
F
Bistoni
Elmo
E
Mannarino
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016470:Bacteremia / Q000175:diagnosis* / Q000382:microbiology; D001419:Bacteria / Q000235:genetics; D002176:Candida albicans / Q000235:genetics; D058387:Candidemia / Q000175:diagnosis* / Q000382:microbiology; D021903:DNA, Ribosomal Spacer / Q000235:genetics; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques; D060885:Multiplex Polymerase Chain Reaction; D060888:Real-Time Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D055815:Young Adult
D021903:DNA, Ribosomal Spacer