Clinical performance evaluation of the Randox Respiratory-fleX device
Research type
Research Study
Full title
Clinical performance evaluation of the Randox Respiratory-fleX device
IRAS ID
368528
Contact name
Kristopher Pentland
Contact email
Sponsor organisation
Randox Laboratories Ltd
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Respiratory infections represent a significant disease burden. Individuals of all ages and health statuses are at risk of developing a bacterial or viral respiratory infection. Individuals who are elderly, immunocompromised, or are in an at risk population such as patients suffering from cystic fibrosis are at a significantly increased risk of serious disease. Rapid and accessible diagnostics are a key part of the patient journey and are most effective when testing is both rapid and accurate.
The purpose of this research is to evaluate the clinical performance of the Randox Respiratory-fleX device for in-vitro diagnostic use (PE-IVDD). The new medical device under evaluation will be compared to a device in routine use and assessed using established criteria. If the comparator and the new device yield inconclusive results, a third independent device will be used as a tiebreaker.
The study will use leftover/archived specimens collected from RCLS sites in Northern Ireland with consent of the specimen donors over the age of 18. Consented individuals will provide their sample for analysis as part of the Randox Testing Service offered to the general public via the Randox Health website. The study will be conducted in an ISO accredited Clinical Laboratory following the predetermined Performance Study Protocol and Standard Operating Procedures of the Laboratory.
The study will last approximately 18-months, where a specimen library will be collected for the first 12-months, followed by a testing window of ~6 months where the devices will be used simultaneously and the sample library will be retrospectively tested. Data will be compiled at the end of the study to determine the outcome of the performance evaluation
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
26/NW/0043
Date of REC Opinion
19 Feb 2026
REC opinion
Favourable Opinion