Loop-mediated isothermal amplification for the early diagnosis of invasive meningococcal disease in children.
Adolescent
C-Reactive Protein
/ metabolism
Child
Child, Preschool
Emergency Service, Hospital
Female
Humans
Infant
Leukocyte Count
Male
Meningococcal Infections
/ blood
Molecular Diagnostic Techniques
Neisseria meningitidis
/ isolation & purification
Nucleic Acid Amplification Techniques
Oropharynx
/ microbiology
Point-of-Care Testing
Predictive Value of Tests
Prospective Studies
accident & emergency
general paediatrics
infectious diseases
Journal
Archives of disease in childhood
ISSN: 1468-2044
Titre abrégé: Arch Dis Child
Pays: England
ID NLM: 0372434
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
received:
09
03
2020
revised:
03
06
2020
accepted:
03
06
2020
pubmed:
27
6
2020
medline:
16
12
2020
entrez:
27
6
2020
Statut:
ppublish
Résumé
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. 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 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. Non-invasive LAMP testing using oropharyngeal swabs provided an accurate fast and minimally invasive mechanism for predicting invasive MD in this study. NCT03378258.
Sections du résumé
BACKGROUND
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.
DESIGN
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
RESULTS
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.
DISCUSSION
Non-invasive LAMP testing using oropharyngeal swabs provided an accurate fast and minimally invasive mechanism for predicting invasive MD in this study.
TRIAL REGISTRATION NUMBER
NCT03378258.
Identifiants
pubmed: 32586928
pii: archdischild-2020-319139
doi: 10.1136/archdischild-2020-319139
doi:
Substances chimiques
C-Reactive Protein
9007-41-4
Banques de données
ClinicalTrials.gov
['NCT03378258']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1151-1156Informations de copyright
© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: JM Holds share options in HiberGene Diagnostics Ltd.