Biofire - Spotfire Evaluation
Research type
Research Study
Full title
Evaluation of Accuracy and Ease of Use of the BioFire SpotFire Respiratory/Sore Throat Panel in a Near-Patient Setting
IRAS ID
271691
Contact name
Virve (Vicky) Enne
Contact email
Sponsor organisation
BioFire Diagnostics, LLC
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Research Summary
Patients often attend medical appointments with symptoms of respiratory infections and/or sore throat. If their doctor suspects a bacterial infection, current practice is to collect a swab sample and send it to the local laboratory for culture testing. It can take several days before the result is returned to the doctor. Their doctor is unsure how to treat the symptoms during this time and may prescribe ineffective or unnecessary antibiotics.
It is hoped in future, that new machines, placed in near-patient settings, will be able to provide a result within an hour, detecting any bacteria or viruses 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 respiratory/sore throat (R/ST) panel of tests using a Biofire SpotFire machine, 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 in the USA, EU and other regions, to allow the use of the SpotFire R/ST Panel as a near-patient in vitro diagnostic test.
In addition to hospital clinics in America, the UK arm of the study will test the Spotfire machine in a doctor's surgery and the A&E department of a large hospital. Adults and children presenting with respiratory infection or sore throat symptoms 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 minutesSummary of Results
At present, when someone has a respiratory infection, such as a cough, cold or sore throat, it is very difficult for doctors to tell if those symptoms are caused by viruses, which don’t respond to antibiotics, or bacteria, which do. Often doctors end up guessing based on the patient’s symptoms and prescribe accordingly, which isn’t ideal.
In this study, we evaluated a new test that quickly detects viruses and bacteria to guide the treatment of children and adults with respiratory infection who attend A&E departments. The new automated 15 min test uses PCR (polymerase chain reaction) to quickly detect the genetic material of viruses and bacteria that commonly cause these infections. Patients from one hospital in the UK and four hospitals in the US, who attended accident and emergency or urgent care clinics with respiratory symptoms were asked to provide samples for the study. Samples were tested using the new test and compared to results obtained using the best currently available techniques. These results show that the new test is just as accurate as current methods while being much faster. Doctors and nurses operating the test were also asked to reply to a questionnaire, which showed that they generally found it very easy to use.
The results of the comparison of this test alongside established methods have been submitted to the relevant regulatory bodies in the UK, Europe and the US. These regulatory agencies will examine the evidence and decide if the test should be given approval to be used in clinical practise. Once the relevant approvals are granted, the test will be available for use in hospitals and other healthcare settings.
REC name
HSC REC B
REC reference
19/NI/0213
Date of REC Opinion
20 Nov 2019
REC opinion
Favourable Opinion