DNAe Diagnostic Evaluation Study

• Research type

  Research Study

• Full title

  DNAe Diagnostic Evaluation Study

• IRAS ID

  237827

• Contact name

  Nishanthy (Nisha) Ranganathan

• Contact email

  Nisha.ranganathan@nhs.net

• Sponsor organisation

  DNA Electronics

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  The objective of this study is to evaluate the DNA Electronics Ltd LiDia™ BSI Test in subjects where there is an indication for the collection of a blood culture. The DNA Electronics Ltd LiDia™ BSI Test will be compared to standard blood culture to determine accuracy of the test in detecting bloodstream infections.
  Samples from the study will be used for internal development purposes to measure and improve the performance of DNAe’s blood stream infection (BSI) test. These data may be used in scientific publications.
  Samples from this study may also be used to demonstrate the performance of the LiDia BSI test in a performance evaluation study. This work is part of the product clinical development phase.

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  18/LO/0798

• Date of REC Opinion

  14 Aug 2018

• REC opinion

  Further Information Favourable Opinion