Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods – a prospective multinational trial

Kutz, Alexander; Hausfater, Pierre; Oppert, Michael; Alan, Murat; Grolimund, Eva; Gast, C.; Alonso, Christine; Wissmann, Christoph; Kuehn, C.; Bernard, Maguy; Huber, Andreas; Müeller, Beat; Schuetz, Philipp

doi:10.1515/cclm-2015-0437

Cited by 29 publications

(12 citation statements)

References 19 publications

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“…Even, we did not measure hsCRP, we believe that ROC AUC for hsCRP would be similar to ROC AUC for CRP. Finally, while measurement of most prognostic blood biomarkers (including ProADM) is now commercially available within few hours, fast point-of-care tests are currently being developed that will enable biomarker measurement within minutes [39]. This will definitively improve the pragmatic bedside use of these biomarkers in future trials and clinical practice.…”

Section: Discussionmentioning

confidence: 99%

The TRIAGE-ProADM Score for an Early Risk Stratification of Medical Patients in the Emergency Department - Development Based on a Multi-National, Prospective, Observational Study

et al. 2016

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IntroductionThe inflammatory biomarker pro-adrenomedullin (ProADM) provides additional prognostic information for the risk stratification of general medical emergency department (ED) patients. The aim of this analysis was to develop a triage algorithm for improved prognostication and later use in an interventional trial.MethodsWe used data from the multi-national, prospective, observational TRIAGE trial including consecutive medical ED patients from Switzerland, France and the United States. We investigated triage effects when adding ProADM at two established cut-offs to a five-level ED triage score with respect to adverse clinical outcome.ResultsMortality in the 6586 ED patients showed a step-wise, 25-fold increase from 0.6% to 4.5% and 15.4%, respectively, at the two ProADM cut-offs (≤0.75nmol/L, >0.75–1.5nmol/L, >1.5nmol/L, p ANOVA <0.0001). Risk stratification by combining ProADM within cut-off groups and the triage score resulted in the identification of 1662 patients (25.2% of the population) at a very low risk of mortality (0.3%, n = 5) and 425 patients (6.5% of the population) at very high risk of mortality (19.3%, n = 82). Risk estimation by using ProADM and the triage score from a logistic regression model allowed for a more accurate risk estimation in the whole population with a classification of 3255 patients (49.4% of the population) in the low risk group (0.3% mortality, n = 9) and 1673 (25.4% of the population) in the high-risk group (15.1% mortality, n = 252).ConclusionsWithin this large international multicenter study, a combined triage score based on ProADM and established triage scores allowed a more accurate mortality risk discrimination. The TRIAGE-ProADM score improved identification of both patients at the highest risk of mortality who may benefit from early therapeutic interventions (rule in), and low risk patients where deferred treatment without negatively affecting outcome may be possible (rule out).

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Section: Discussionmentioning

confidence: 99%

The TRIAGE-ProADM Score for an Early Risk Stratification of Medical Patients in the Emergency Department - Development Based on a Multi-National, Prospective, Observational Study

et al. 2016

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“…In general, point-of-care technology has the advantage of high availability and short time to results for clinicians [13]. Patients randomized to the PCT group had a shorter antibiotic treatment course of 3.5 days compared to 8.5 for patients in the control group.…”

Section: Introductionmentioning

confidence: 99%

Procalcitonin-guided diagnosis and antibiotic stewardship revisited

Sager

Kutz

Müeller

et al. 2017

BMC Med

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Several controlled clinical studies have evaluated the potential of the infection biomarker procalcitonin (PCT) to improve the diagnostic work-up of patients with bacterial infections and its influence on decisions regarding antibiotic therapy. Most research has focused on lower respiratory tract infections and critically ill sepsis patients. A clinical utility for PCT has also been found for patients with urinary tract infections, postoperative infections, meningitis, and patients with acute heart failure with possible superinfection (i.e., pneumonia). In these indications, PCT levels measured on hospital admission were found to substantially reduce the initiation of antibiotic treatment in low-risk situations (i.e., bronchitis, chronic obstructive pulmonary disease exacerbation). For more severe infections (i.e., pneumonia, sepsis), antibiotic stewardship by monitoring of PCT kinetics resulted in shorter antibiotic treatment durations with early cessation of therapy. Importantly, these strategies appear to be safe without increasing the risk for mortality, recurrent infections, or treatment failures. PCT kinetics also proved to have prognostic value correlating with disease severity (i.e., pancreatitis, abdominal infection) and resolution of illness (i.e., sepsis). Although promising findings have been published in these different types of infections, there are a number of limitations regarding PCT, including suboptimal sensitivity and/or specificity, which makes a careful interpretation of PCT in the clinical context mandatory. This narrative review aims to update clinicians on the strengths and limitations of PCT for patient management, focusing on research conducted within the last 4 years.

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“…POCT methods for PCT are also commercially available. Brahms originally produced the first automated monoclonal sandwich PCT assay, which is available for several clinical chemistry immunoassay analytical platforms; this was subsequently followed by the release of a POCT PCT assay (Brahms PCT Direct) which demonstrated very good performance, comparable to that of their original PCT assay [120]. Radiometer have also developed a POCT PCT assay for their AQT90 Flex analyser, which has also been shown to have good correlation with the original Brahms PCT assay.…”

Section: Point-of-care Testing (Poct) For Sepsismentioning

confidence: 99%

Biomarkers for Point-of-Care Diagnosis of Sepsis

2020

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Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. In 2017, almost 50 million cases of sepsis were recorded worldwide and 11 million sepsis-related deaths were reported. Therefore, sepsis is the focus of intense research to better understand the complexities of sepsis response, particularly the twin underlying concepts of an initial hyper-immune response and a counter-immunological state of immunosuppression triggered by an invading pathogen. Diagnosis of sepsis remains a significant challenge. Prompt diagnosis is essential so that treatment can be instigated as early as possible to ensure the best outcome, as delay in treatment is associated with higher mortality. In order to address this diagnostic problem, use of a panel of biomarkers has been proposed as, due to the complexity of the sepsis response, no single marker is sufficient. This review provides background on the current understanding of sepsis in terms of its epidemiology, the evolution of the definition of sepsis, pathobiology and diagnosis and management. Candidate biomarkers of interest and how current and developing point-of-care testing approaches could be used to measure such biomarkers is discussed.

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Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods – a prospective multinational trial

Abstract: This study found a high diagnostic accuracy and a faster time to result of B·R·A·H·M·S PCT direct in the ED setting, allowing shortening time to therapy and a more wide-spread use of PCT.

Cited by 29 publications

References 19 publications

The TRIAGE-ProADM Score for an Early Risk Stratification of Medical Patients in the Emergency Department - Development Based on a Multi-National, Prospective, Observational Study

The TRIAGE-ProADM Score for an Early Risk Stratification of Medical Patients in the Emergency Department - Development Based on a Multi-National, Prospective, Observational Study

Procalcitonin-guided diagnosis and antibiotic stewardship revisited

Biomarkers for Point-of-Care Diagnosis of Sepsis

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