Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Diagnostic Accuracy of Multiplex PCR in Early Onset Neonatal Sepsis

Version 1 : Received: 20 October 2023 / Approved: 21 October 2023 / Online: 24 October 2023 (08:11:56 CEST)

A peer-reviewed article of this Preprint also exists.

Stein, A.; Soukup, D.; Rath, P.-M.; Felderhoff-Müser, U. Diagnostic Accuracy of Multiplex Polymerase Chain Reaction in Early Onset Neonatal Sepsis. Children 2023, 10, 1809. Stein, A.; Soukup, D.; Rath, P.-M.; Felderhoff-Müser, U. Diagnostic Accuracy of Multiplex Polymerase Chain Reaction in Early Onset Neonatal Sepsis. Children 2023, 10, 1809.

Abstract

Early onset neonatal sepsis is a significant contributor to neonatal morbidity and mortality. Although blood cultures remain the diagnostic gold standard, they detect pathogens in only a minority of suspected cases. This study compared the accuracy of blood cultures with a rapid multiplex PCR test. Newborns at risk for neonatal sepsis were prospectively screened as recommended per national guidelines. Evaluations included laboratory parameters (CrP, IL6, differential blood count), blood culture, and a molecular multiplex PCR test (ROCHE LightCycler SeptiFast) identifying 20 common microbial agents. Blood samples were taken simultaneously from umbilical cord or venous sources on the first day of life. Of 229 infants included, 69% were born preterm. Blood culture and multiplex PCR sensitivity were 7.4% and 11.1% respectively. Specificity, negative and positive predictive values between methods showed no significant variance, though multiplex PCR had more false positives due to contamination. The limited sensitivity of blood cultures for early onset neonatal sepsis is concerning. Despite quicker results, multiplex PCR does not enhance diagnostic accuracy or antibiotic therapy guidance, thus it can not be recommended for this indication.

Keywords

neonatal sepsis; early onset sepsis; multiplex PCR; infection; neonate; diagnosis; pathogen detection

Subject

Medicine and Pharmacology, Pediatrics, Perinatology and Child Health

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