Diagnostic accuracy of the ROCHE Septifast PCR system for the rapid detection of blood pathogens in neonatal sepsis – A prospective clinical trial

Introduction:  Diagnosis of neonatal sepsis remains a major challenge in neonatology. Most molecularbased methods are not customized for neonatal requirements. The aim of the present study was to assess the diagnostic accuracy of a modified multiplex PCR protocol for the detection of neonatal sepsis using small blood volumes.

Methods: 212 episodes of suspected neonatal late onset sepsis were analyzed prospectively using the Roche SeptiFast® MGRADE PCR with a modified DNA extraction protocol and software-handling tool. Results were compared to blood culture, laboratory biomarkers and clinical signs of sepsis.

Results: Of 212 episodes, 85 (40.1%) were categorized as “not infected”. Among these episodes, 1 was false positive by blood culture (1.2%) and 23 were false positive by PCR (27.1%). Of 51 (24.1%) episodes diagnosed as “culture proven sepsis”, the same pathogen was detected by blood culture and PCR in 39 episodes (76.5%). In 8 episodes, more pathogens were detected by PCR compared to blood culture, and in 4 episodes the pathogen detected by blood culture was not found by PCR. One of these episodes was caused by Bacillus cereus, a pathogen not included in the PCR panel. In 76/212 (35.8%) episodes, clinical sepsis was diagnosed. Among these, PCR yielded positive results in 39.5% of episodes (30/76 episodes). For culture-positive sepsis, PCR showed a sensitivity of 90.2% (95%CI 86.2– 94.2%) and a specificity of 72.9% (95%CI 67.0–79.0%).

Conclusion: The Roche SeptiFast® MGRADE PCR using a modified DNA extraction protocol showed acceptable results for rapid detection of neonatal sepsis in addition to conventional blood culture. The benefit of rapid pathogen detection has to be balanced against the considerable risk of contamination, loss of information on antibiotic sensitivity pattern and increased costs.

Published in PLOS One

Authors / corresponding author* 

Julia Straub,1; Helga Paula, 2; Michaela Mayr, 1; David Kasper, 3; Ojan Assadian, 2;  Angelika Berger, 1; Judith Rittenschober-Böhm, 1*

1 Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Medical University Vienna, Vienna, Austria
2 Department of Hospital Epidemiology and Infection Control, Medical University Vienna, Vienna, Austria
3 Department of Pediatrics and Adolescent Medicine, Research Core Unit of Pediatric Biochemistry and Analytics, Medical University Vienna, Vienna, Austria

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