The SIMPLIFI Study
Research type
Research Study
Full title
The SIMPLIFI (Single use Isothermal aMPLIfication testing for Flu Illnesses) Study. Evaluation of a single use point of care device for the diagnosis of influenza and other respiratory pathogens in clinical upper airway samples using isothermal amplification - a feasibility study.
IRAS ID
266797
Contact name
Onn Min Kon
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
This is a prospective single centre feasibility study in the accident and emergency (A+E) department of Imperial College Healthcare NHS Trust (ICHNT) in patients presenting with influenza like illness (ILI).
The primary objective is to assess the feasibility of this single use device for the diagnosis of influenza and other respiratory pathogens in upper airway samples at the point of care (POC) in a real-life setting and compare the results against the conventional laboratory diagnostic methods of Polymerase Chain Reaction (PCR) testing. Further objectives are to compare the results to the analytical study data and laboratory test on stored samples as well as develop a bank of samples for further testing of the device in laboratory conditions.
One nasal swab to be taken per patient recruited in addition to the swab(s) (nasal, nasopharyngeal or throat swab) taken for standard care. Routine sample(s) (A) to be processed for standard PCR testing in the laboratory and/or rapid flu testing (Cepheid, Sunnyvale, CA, USA) as per standard clinical work flow. Second sample (B) to be taken for evaluation under the study and either: (i) transferred to the new device buffer tube and promptly tested in a test device or (ii) if no device is available for prompt testing, add the swab to a viral storage/transport buffer tube as per standard procedures and freeze for long-term storage and later testing.
As this is a feasibility study, diagnostic standard of care tests should be performed as per the clinical pathway with routine sample(s) (A) and the results of the test devices should not affect clinical decisions and should not be disclosed to either the patient or the clinician.
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/1776
Date of REC Opinion
29 Jan 2020
REC opinion
Further Information Favourable Opinion