A novel optical biosensor for the early diagnosis of sepsis and severe Covid-19: the PROUD study
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RESEARCH ARTICLE
Open Access
A novel optical biosensor for the early diagnosis of sepsis and severe Covid-19: the PROUD study Sarantia Doulou1, Konstantinos Leventogiannis1, Maria Tsilika1, Matthew Rodencal2, Konstantina Katrini1, Nikolaos Antonakos1, Miltiades Kyprianou1, Emmanouil Karofylakis1, Athanassios Karageorgos1, Panagiotis Koufargyris1, Gennaios Christopoulos3, George Kassianidis4, Kimon Stamatelopoulos5, Robert Newberry2† and Evangelos J. Giamarellos-Bourboulis1,6*†
Abstract Background: The accuracy of a new optical biosensor (OB) point-of-care device for the detection of severe infections is studied. Methods: The OB emits different wavelengths and outputs information associated with heart rate, pulse oximetry, levels of nitric oxide and kidney function. At the first phase, recordings were done every two hours for three consecutive days after hospital admission in 142 patients at high-risk for sepsis by placing the OB on the forefinger. At the second phase, single recordings were done in 54 patients with symptoms of viral infection; 38 were diagnosed with COVID-19. Results: At the first phase, the cutoff value of positive likelihood of 18 provided 100% specificity and 100% positive predictive value for the diagnosis of sepsis. These were 87.5 and 91.7% respectively at the second phase. OB diagnosed severe COVID-19 with 83.3% sensitivity and 87.5% negative predictive value. Conclusions: The studied OB seems valuable for the discrimination of infection severity. Keywords: Sepsis, Optical biosensor, Diagnosis, Severity, COVID-19, SARS-CoV-2
Background Sepsis is the most common cause of death nowadays. A recent survey showed more than 48 million cases in 2017 worldwide, six million of which died [1]. The recent sepsis definition of sepsis as a life-threatening organ dysfunction associated with a dysregulated host response to an infection [2] allows for the severe infection by the * Correspondence: [email protected] † Robert Newberry and Evangelos J. Giamarellos-Bourboulis contributed equally to this work. 1 4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, 124 62 Athens, Greece 6 4th Department of Internal Medicine, ATTIKON University General Hospital, 1 Rimini Str, 12462 Athens, Greece Full list of author information is available at the end of the article
novel SARS-CoV-2 (COVID-19) to be considered a case of sepsis since this is driven by a complex immune dysregulation of the host [3]. The early detection of sepsis is critical for management since favorable outcomes are associated with the start of treatment as fast as one hour [4–6]. Early diagnosis is, however, difficult to achieve in everyday clinical practice which is hampered by time delays for laboratory and radiological exams. Decision-making is often based on clinical judgment and on quick point-of-care testing. Pulse oximeter devices are often helpful to evaluate clinical severity but they miss specificity for a disease state. To achieve so, they need to be enriched with measurements
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