Trial reportIntensive care medicine2015
Diagnostic accuracy of SeptiFast multi-pathogen real-time PCR in the setting of suspected healthcare-associated bloodstream infection.
Trial report in Intensive care medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.
- Direct 16S/18S rRNA Gene PCR Followed by Sanger Sequencing as a Clinical Diagnostic Tool for Detection of Bacterial and Fungal Infections: a Systematic Review and Meta-Analysis.Journal of clinical microbiology · 2023Pooled it
- Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2020Trial
- New Diagnostics for Fungal Infections in Transplant Infectious Disease: A Systematic Review.Journal of fungi (Basel, Switzerland) · 2025Review
- Rapid molecular assays versus blood culture for bloodstream infections: a systematic review and meta-analysis.EClinicalMedicine · 2025Article
- Performance of real-time PCR in suspected haemodialysis catheter-related bloodstream infection: a proof-of-concept study.Clinical kidney journal · 2023Article
- Clinical Diagnostic Performance of Droplet Digital PCR for Suspected Bloodstream Infections.Microbiology spectrum · 2023Article
- Development and clinical validation of a droplet digital PCR assay for detecting Acinetobacter baumannii and Klebsiella pneumoniae in patients with suspected bloodstream infections.MicrobiologyOpen · 2021Article
- Validation of an Isothermal Amplification Platform for Microbial Identification and Antimicrobial Resistance Detection in Blood: A Prospective Study.Indian journal of critical care medicine : peer-reviewed, official publication of Indian Society of Critical Care Medicine · 2021Article
- Multiplex PCR Based Strategy for Detection of Fungal Pathogen DNA in Patients with Suspected Invasive Fungal Infections.Journal of fungi (Basel, Switzerland) · 2020Article
- Diagnosis and management of catheter-related bloodstream infections in patients on home parenteral nutrition.Frontline gastroenterology · 2020Review
- Diagnostic Performance of a Novel Multiplex PCR Assay for Candidemia among ICU Patients.Journal of fungi (Basel, Switzerland) · 2019Article
- Emerging Technologies for Molecular Diagnosis of Sepsis.Clinical microbiology reviews · 2018Review
- The next generation of rapid point-of-care testing identification tools for ventilator-associated pneumonia.Annals of translational medicine · 2017Review
- Real -time PCR for early microbiological diagnosis: is it time?Intensive care medicine · 2017Article
- The Unyvero P55 'sample-in, answer-out' pneumonia assay: A performance evaluation.Biomolecular detection and quantification · 2017Article
- Biochips for Direct Detection and Identification of Bacteria in Blood Culture-Like Conditions.Scientific reports · 2017Article
- Focus on severe infections.Intensive care medicine · 2017Review
- Focus on optimization of early antimicrobial therapy in ICU-acquired infections.Intensive care medicine · 2016Review
- Article
- Focus on infection and sepsis in intensive care patients.Intensive care medicine · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 1 country.
Funding
Abstract
purposeSeptiFast is a real-time PCR assay which targets ribosomal DNA sequences of bacteria and fungi, enabling detection and identification of the commonest pathogens in blood within a few hours, including those acquired in healthcare settings. We report here the first detailed assessment of SeptiFast that focuses on healthcare-associated bloodstream infections which develop during routine critical care.
methodsThis was a prospective multicentre study designed to compare the clinical diagnostic accuracy of SeptiFast versus microbiological culture and independent clinical adjudication. This Phase III diagnostic study was performed in an adequately sized cohort of adult patients who developed new signs of suspected bloodstream infection while receiving routine critical care.
resultsOf 1,006 new episodes of suspected bloodstream infection in 853 patients, 922 (92 %) of these episodes in 795 patients met the inclusion criteria of the study. Patients had been exposed to a median of 8 days (interquartile range 4-16) of hospital care and had received high levels of organ support and recent antibiotic exposure. The SeptiFast test, when compared with bloodstream infection at the species/genus level, had a greater specificity [0.86, 95 % confidence interval (CI) 0.83-0.88] than sensitivity (0.50, 95 % CI 0.39-0.61). There was a low prevalence of blood culture-proven pathogens (9.2 %, 95 % CI 7.4-11.2 %), and the post-test probabilities of both a positive (26.3 %, 95 % CI 19.8-33.7 %) and a negative SeptiFast test (5.6 %, 95 % CI 4.1-7.4 %) indicated potential limitations of this technology in diagnosing bloodstream infection.
conclusionWhen compared with blood culture, SeptiFast is likely to have limited utility for the diagnosis of healthcare-associated bloodstream infection in critical care patients despite its potential to deliver results more rapidly.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.