Diagnostic accuracy of non-sterile sites polymerase chain reaction for diagnosing enterovirus infection in infants under ninety days of age with fever without source: cross-sectional multicentre diagnostic study

Abstract

BACKGROUND: Fever without source is a very frequent cause of consultation in paediatric emergencies, in addition, children under 3 months are those who are more susceptible to fever as the only manifestation of their illness. Also, these children are at high risk of bacteraemia, leading to many invasive diagnostic tests, hospital admissions and empirical antibiotics. Although bacterial aetiology is the most life-threatening agent, the most frequent aetiology is viral and among this, enteroviruses. The routine inclusion of enterovirus diagnosis has been a great advance in being able to rule out bacteraemia with greater certainty and avoid more invasive tests, hospitalizations and unnecessary treatments. Currently, only the detection of enteroviruses at sterile sites (blood and/or cerebrospinal fluid) in fever without source is validated. Due to the physiopathology of enterovirus, we considered the possible detection of enterovirus by PCR in non-sterile samples. Thus, this study aims to evaluate the diagnostic accuracy of these non-sterile samples PCR in the detection of enteroviruses infection in children under 90 days of age with fever without source. OBJECTIVE: The aim of this study is to evaluate the diagnostic accuracy of nasopharyngeal aspirate, throat swab and stool PCR using blood and/or CSF PCR as the standard reference for the detection of enterovirus infection in infants under 90 days of age with fever without source. DESING AND SETTING: Is a cross-sectional and multicentre diagnostic study, that will be recruited at the paediatric emergencies units of five Catalan hospitals of the national public health system. PARTICIPANTS: The population target will be children under 90 days of age who present fever without source, according to the medical criteria at the time of hospitals admission and have the consent of parents/legal guardians to participate in the study. METHODS: Patients included in the study will have samples taken for enterovirus PCR from nasopharyngeal aspirate, throat swab, stool, blood and cerebrospinal fluid (when clinically indicated). In addition, whenever blood and/or cerebrospinal fluid is collected, a bacterial culture will be also performed. Furthermore, we will perform a blood and cerebrospinal fluid analysis (when collected)

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