Diagnostic evaluation of a rapid test for children with suspected RSV
Research type
Research Study
Full title
Clinical diagnostic accuracy evaluation of the Respiratory Syncytial Virus (RSV) component of the Roche cobas® Liat system on paediatric patients presenting with an acute respiratory illness and possible RSV cause
IRAS ID
216215
Contact name
Malcolm Brodlie
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 4 months, 29 days
Research summary
RSV is a virus like flu, which is very infectious and tends to spread in winter.
RSV is often mild but it can cause breathing difficulties. It is a common reason for children being brought to emergency departments or being admitted to hospital.A new test for RSV has been developed which provides the result in 20 minutes. The standard test can take a day or more. This study is to decide if the new test is as accurate as the usual test.
If it was found to be accurate, it would help doctors decide who needs to be kept away from others to prevent the virus spreading between children. It could also help decide if antibiotics should be given or not. At the moment there is no good treatment for RSV itself, but new drugs are being tested, and could be available in the future. The new test would then help to decide who should get the new treatment.Parents and carers of children under the age of 2 will be invited to take part in this study if the child is unwell and the illness could be due to RSV. A sample for testing is collected in the standard way which involves a flexible tube being used to suck some secretions from the nose.
The sample will be tested for RSV with both the standard test used by the hospital and the new fast test. The parents or carers and the doctors will be given the result of the standard test but not of the new test. It will only be safe to act on the test result when we know for sure that the test is accurate.
Parents and carers will also be invited to tell the research team what they think and feel about the test.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0456
Date of REC Opinion
22 Nov 2016
REC opinion
Further Information Favourable Opinion