Loop-mediated isothermal amplification for the early diagnosis of invasive meningococcal disease in children.

<bold>Background: </bold>Rapid molecular diagnostic testing has the potential to improve the early recognition of meningococcal disease (MD). The aim of this study was to report on the diagnostic test accuracy of point-of-care loop-mediated isothermal amplification (LAMP) in the diagnosis of MD.<bold>Design: </bold>Data were collected prospectively from three UK emergency departments (ED) between November 2017 and June 2019. Consecutive children under 18 years of age attending the ED with features of MD were eligible for inclusion. The meningococcal LAMP test (index test) was performed on a dry swab of the child's oropharynx. Reference standard testing was the confirmation of invasive MD defined as positive N. meningitidis culture or PCR result from a sterile body site (blood or cerebrospinal fluid).<bold>Results: </bold>There were 260 children included in the final analysis. The median age was 2 years 11 months and 169 (65%) children were aged 5 years or younger. The LAMP test was negative in 246 children and positive in 14 children. Of the 14 children with positive LAMP tests, there were five cases of invasive MD. Of the 246 children with negative LAMP tests, there were no cases of invasive MD. The sensitivity of LAMP testing was 1.00 and the specificity was 0.97. The negative and positive predictive values were 1.00 and 0.36, respectively. The positive likelihood ratio was 28.3.<bold>Discussion: </bold>Non-invasive LAMP testing using oropharyngeal swabs provided an accurate fast and minimally invasive mechanism for predicting invasive MD in this study.<bold>Trial Registration Number: </bold>NCT03378258. [ABSTRACT FROM AUTHOR]