Diagnostic accuracy study of PCRctic for neonatal meningitis.

• Research type

  Research Study

• Full title

  Multi-centre diagnostic accuracy study of PCRctic - a novel 16S rDNA PCR assay for exclusion of neonatal bacterial meningitis.

• IRAS ID

  251243

• Contact name

  Artur Abelian

• Contact email

  artur.abelian@wales.nhs.uk

• Sponsor organisation

  BCUHB

• Duration of Study in the UK

  1 years, 6 months, 2 days

• Research summary

  PCRctic is an innovative assay based on 16S rDNA PCR technology that has been designed to detect a single bacterium in neonatal cerebro-spinal fluid (CSF). The assay’s potential for accurate, fast and inexpensive discrimination of bacteria-free CSF makes it an ideal adjunct for confident exclusion of bacterial meningitis in newborn babies where the negative predictive value of bacterial culture is poor.

  Polymerase chain reaction (PCR) has tremendous sensitivity but is can only test for one type of bacteria at a time.
  Bacterial cultures can test for many bacteria at a time but their sensitivity is poor, especially in newborns.
  16S rDNA PCR technology combines the advantages of both: it can detect a single bacterium of any type in one go.
  It has an important procedural limitation, which we managed to overcome when we developed PCRctic in 2013 - 2014 (IRAS 129486). The work was done at the world-renowned MRC Laboratory of Molecular Biology in Cambridge and the assay was subsequently optimised for NHS molecular-diagnostics laboratory (Addenbrookes Hospital, Cambridge) in 2015. In 2016-2017 we conducted a feasibility study of the assay on the Neonatal Unit at Rosie Hospital in Cambridge (IRAS 205837), which enabled to optimise the standard operating procedures for CSF collection and achieve assay specificity of 90 - 96% (results have been presented at the UK’s Neonatal Society meeting, Royal College of Paediatrics and Child Health Conference, International Neonatal Association Conference, and have been submitted for publication).

  The next stage of the assay validation is to test its sensitivity and define its negative predictive value in a cross-sectional study. The low prevalence of neonatal bacterial meningitis means that a large multi-centre study will be required. Statistical analysis shows that the population that will need to be involved in such a study is at least 36,000 live born babies.

• REC name

  Wales REC 5

• REC reference

  18/WA/0352

• Date of REC Opinion

  24 Oct 2018

• REC opinion

  Favourable Opinion