Abstract
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 was 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 meningococcal disease defined as positive N. meningitidis culture or PCR result from a sterile body site (blood or CSF).
Results
There were 260 children included in the final analysis. The median age was two years 11 months and 169 (65%) children were aged five 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 meningococcal disease. Of the 246 children with negative LAMP tests there were no cases of invasive meningococcal disease. 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 meningococcal disease in this study.
Registration
Registered at https://www.clinicaltrials.gov (trial registration: NCT03378258) on the 19th of December 2017.
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 was 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 meningococcal disease defined as positive N. meningitidis culture or PCR result from a sterile body site (blood or CSF).
Results
There were 260 children included in the final analysis. The median age was two years 11 months and 169 (65%) children were aged five 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 meningococcal disease. Of the 246 children with negative LAMP tests there were no cases of invasive meningococcal disease. 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 meningococcal disease in this study.
Registration
Registered at https://www.clinicaltrials.gov (trial registration: NCT03378258) on the 19th of December 2017.
| Original language | English |
|---|---|
| Pages (from-to) | 1151-1156 |
| Number of pages | 6 |
| Journal | Archives of Disease in Childhood |
| Volume | 105 |
| Issue number | 12 |
| Early online date | 25 Jun 2020 |
| DOIs | |
| Publication status | Published - Dec 2020 |
Bibliographical note
© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.Keywords
- 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