ArticlePloS one2017
Diagnostic accuracy of the ROCHE Septifast PCR system for the rapid detection of blood pathogens in neonatal sepsis-A prospective clinical trial.
Article in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.
- Molecular assays for the diagnosis of sepsis in neonates: a diagnostic test accuracy review.The Cochrane database of systematic reviews · 2025Pooled it
- Neonatal Bloodstream Infections: A Narrative Review on Diagnostic and Therapeutic Challenges and Prospects in Developing Countries.Health science reports · 2026Article
- Bacterial DNA detection in blood using PCR/ESI-MS in neonates with suspected early onset infection.Frontiers in cellular and infection microbiology · 2025Observational
- Rapid molecular assays versus blood culture for bloodstream infections: a systematic review and meta-analysis.EClinicalMedicine · 2025Article
- Assessing Diagnostic Performance of Molecular Culture for Neonatal Sepsis: Protocol of the CHAMPIONS Study.Diagnostics (Basel, Switzerland) · 2024Article
- ISCCM Position Statement on the Management of Invasive Fungal Infections in the Intensive Care Unit.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2024Article
- Development of two multiplex PCR assays for rapid detection of eleven Gram-negative bacteria in children with septicemia.Tropical medicine and health · 2024Article
- Diagnostic Accuracy of Multiplex Polymerase Chain Reaction in Early Onset Neonatal Sepsis.Children (Basel, Switzerland) · 2023Article
- Nano-Biotechnology for Bacteria Identification and Potent Anti-bacterial Properties: A Review of Current State of the Art.Nanomaterials (Basel, Switzerland) · 2023Review
- Diagnosis of invasive fungal infections: challenges and recent developments.Journal of biomedical science · 2023Review
- Effects of Sepsis on Immune Response, Microbiome and Oxidative Metabolism in Preterm Infants.Children (Basel, Switzerland) · 2023Review
- Clinical Utility of the FilmArrayMicroorganisms · 2023Article
- The Role of Coagulase-Negative Staphylococci Biofilms on Late-Onset Sepsis: Current Challenges and Emerging Diagnostics and Therapies.Antibiotics (Basel, Switzerland) · 2023Review
- Rapid DNA visual detection of polymicrobial bloodstream infection using filter paper.Scientific reports · 2022Article
- Diagnosis of neonatal sepsis: the past, present and future.Pediatric research · 2022Review
- Molecular Markers of Antifungal Resistance: Potential Uses in Routine Practice and Future Perspectives.Journal of fungi (Basel, Switzerland) · 2021Review
- Rapid detection of bacteria in bloodstream infections using a molecular method: a pilot study with a neonatal diagnostic kit.Molecular biology reports · 2020Observational
- Is European Medicines Agency (EMA) sepsis criteria accurate for neonatal sepsis diagnosis or do we need new criteria?PloS one · 2019Article
- Article
- Detection of pathogenic microorganisms from bloodstream infection specimens using TaqMan array card technology.Scientific reports · 2018Article
Corrections and comments
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDiagnosis of neonatal sepsis remains a major challenge in neonatology. Most molecular-based 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.
methods212 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.
resultsOf 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%).
conclusionThe 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.
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