Biofire - Spotfire Evaluation Vaginitis

• Research type

  Research Study

• Full title

  Evaluation of Accuracy and Ease of Use of the BIOFIRE SPOTFIRE Vaginitis (VG) Panel on the BIOFIRE SPOTFIRE System in a Near-Patient Setting

• IRAS ID

  349034

• Contact name

  Virve (Vicky) Enne

• Contact email

  virve.enne@kcl.ac.uk

• Sponsor organisation

  BioFire Diagnostics, LLC / bioMérieux SA

• Duration of Study in the UK

  1 years, 0 months, 30 days

• Research summary

  Vaginal discharge is one of the most common reasons for women to attend primary care. This can be caused by vaginitis and cervicitis, two often indistinguishable conditions caused by an infection. Current practice is to collect a swab sample and send it to the local lab for testing. It can take several days before the result is known, if the doctor is unsure how to treat the symptoms during this time they may prescribe ineffective or unnecessary antibiotics.
  It is hoped in the future that new machines, placed in near-patient settings, will be able to provide a result within an hour or less, detecting any organisms that are present and therefore leading to better treatment and antimicrobial stewardship.
  The purpose of this observational, non-interventional clinical evaluation is to assess both the diagnostic accuracy of a new panel of tests using a Biofire SpotFire instrument in patients who are symptomatic and also asymptomatic, compared to reference samples as well as the ease-of-use of the system when used by staff in the near-patient setting. The intention is for these data to support regulatory applications to allow the use of the SpotFire Panel as a near-patient in vitro diagnostic test.
  In addition to hospital clinics in the USA, the UK arm of the study will test the Spotfire instrument in two specialist clinics in London. Adults presenting with relevant symptoms or criteria will be eligible. If they agree to take part in the study they will continue with all standard care, but donate some sample and a small amount of data for this research. As the study is observational, neither they nor their treating doctor will be told the result and their clinical care will not be changed. Total participant study visit time will be up to 30 minutes
  

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  25/NE/0071

• Date of REC Opinion

  29 May 2025

• REC opinion

  Further Information Favourable Opinion