Clinical performance evaluation of the Randox STI-fleX qPCR
Research type
Research Study
Full title
Clinical performance evaluation of the Randox STI-fleX qPCR
IRAS ID
359709
Contact name
Kristopher Pentland
Contact email
Sponsor organisation
Randox Laboratories Ltd
Duration of Study in the UK
0 years, 2 months, 23 days
Research summary
Sexually transmitted infections (STIs) are a considerable threat to public health worldwide. They can cause acute urogenital conditions, with some of the etiological agents also infecting the rectum and pharynx. Many STIs are generally asymptomatic in the early stages of infection, increasing the potential for undetected transmission. If left undiagnosed and untreated, common STIs may cause complications and long-term health problems.
The Randox STI-fleX qPCR device family is designed for the qualitative detection and differentiation of DNA from nine common STIs in urine or swab samples. Quantitative polymerase chain reaction (qPCR) is a sensitive and specific PCR-based technology that allows for the selective amplification and detection of target nucleic acid from a sample using fluorescent dyes. The fluorescent signal generated during PCR amplification increases exponentially with each PCR cycle and can be measured, enabling simultaneous detection of all targets. The Randox STI-fleX qPCR device family was developed to replace the previous generation of the device, the Randox Evidence Investigator™ STI Multiplex Array II, with a simpler and quicker STI testing solution.The study will be conducted at Randox Clinical Laboratory Services (RCLS), which provides routine STI testing services, typical of the intended use environment of the Randox STI-fleX qPCR device family. The study will evaluate de-identified residual samples received at RCLS during routine STI diagnostic testing over approximately 60 days. Samples will be collected from persons aged ≥18 years who are suspected of having an STI infection, at increased risk of STI, have a known exposure to any STI, or contact tracing. No clinical decisions will be made with the results from this study however, as patient samples will have been previously tested and reported with alternative methods. The study aims to assess the performance of the Randox STI-fleX qPCR device family for potential use in routine STI testing.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0125
Date of REC Opinion
14 Jul 2025
REC opinion
Favourable Opinion