Nasal swabs for development of R-ID assay_V1
Research type
Research Study
Full title
Collection of the nasal swabs to assist development and initial evaluation of new Respiratory Identification Assay (R-ID) for detection of respiratory pathogens
IRAS ID
230516
Contact name
Irina Barbolina
Contact email
Sponsor organisation
LIG Biowise
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
Respiratory tract infections are common diseases caused by viruses or bacteria and only bacterial infections require antibiotics. Respiratory tract infections are usually diagnosed based on the presented signs and symptoms and the antibiotics are prescribed if bacterial infection is suspected.
R-ID is a molecular-based assay, which being developed by the sponsor, combines pathogen lysis with in-situ amplification of pathogen DNA for rapid detection of infections to assist clinical diagnosis and justify decision of prescribing antibiotics.
This project aims to collect non-invasive clinical samples (nasal swabs) from participants willing to donate them for research. The collected swabs will assist research, development, and initial evaluation of the assay at the pre-prototype stage. Early involvement of clinical specimens will help to develop the robust and sensitive diagnostic tool suitable for the point of care, where such samples can be taken. The aim is to collect swabs from symptomatic and asymptomatic patients: 1) patients with symptoms of upper respiratory tract infection (Index patients) and 2) healthy individuals without symptoms of upper respiratory tract infections (control patients). The samples collection will be carried out at one research site in Manchester - the Robert Darbishire Practice. The adult patients aged 18+ with and without symptoms of upper respiratory tract infections seeking visit to The Robert Darbishire GP practice in the period of 02.2018 – 04.2018 would be eligible to participate and will be asked for consent to collect and donate a nasal swab. Potential participants will be asked to consent their agreement of participation and provide nasal swab at the end of their scheduled appointment at the Practice, which will take up to 30 min. No additional visits/ sampling will be required.
Collected specimens will be transported to the sponsor's laboratory for isolation and of microbial DNA and testing it for the presence of common respiratory pathogens.REC name
North West - Preston Research Ethics Committee
REC reference
18/NW/0051
Date of REC Opinion
6 Feb 2018
REC opinion
Favourable Opinion