CompletedObservational

Clinical performance evaluation of a quantitative Randox STI-fleX qPCR device for sexually transmitted infections

This study is evaluating a new testing device, the Randox STI-fleX qPCR, designed to detect nine common sexually transmitted infections (STIs) more quickly and accurately. Many STIs don't show symptoms early on, which can lead to them spreading and causing long-term health problems if not treated. By using existing, anonymous samples from people suspected of having an STI or at higher risk, researchers will compare the new device's results with standard tests. This will help them understand if the STI-fleX qPCR can improve how STIs are diagnosed, leading to better public health outcomes. Since no new samples are collected, there are no risks to individuals.

At a glance

Status

Completed

Sponsor

Randox (United Kingdom)

Enrolment target

640

Start

29 Jul 2025

Estimated completion

31 Oct 2025

Detection of sexually transmitted infections

What is this study about?

Imagine you're trying to spot a tiny, hidden object in a big picture. That's a bit like detecting sexually transmitted infections (STIs) – many don't show clear signs early on. If STIs aren't found and treated quickly, they can cause health problems down the line, and people might unknowingly pass them on to others. This study is all about making it easier and faster to find these 'hidden' infections.

Researchers are looking at a new device called the Randox STI-fleX qPCR. Think of it as a special magnifying glass designed to spot nine common STIs. The goal is to see if this new test works better than the methods healthcare providers currently use. If it does, it could mean quicker and more accurate diagnoses for people, which helps them get treatment sooner and stops STIs from spreading.

To do this, scientists are using existing, anonymous samples that have already been tested in clinics. They'll run these samples through the new STI-fleX qPCR device and compare the results with the original tests. This helps them understand how well the new device performs. This study doesn't involve testing new patients or giving anyone medication – it's purely about checking the performance of this new test in a laboratory setting.

Key takeaways

Tests a new device (STI-fleX qPCR) for detecting STIs.
Uses existing, anonymous samples – no direct patient involvement.
Aims to improve accuracy and speed of STI diagnosis.
No health risks to individuals participating in the study.
Funded by Randox Laboratories Ltd.

Who may be eligible?

This study is using existing, anonymous samples, so you won't be asked to provide new samples or treatments. The samples being used would have originally come from people aged 18 or older.

These samples were from individuals who were suspected of having an STI, were at a higher risk of getting one, knew they had been exposed to an STI, or were part of contact tracing efforts.

Basically, if a sample was dirty or damaged in a way that would stop it from being properly tested, it wouldn't be included in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older? (This applied to the original samples.)
Were you suspected of having an STI, or at higher risk? (This applied to the original samples.)
Did you have known exposure to an STI, or were you part of contact tracing? (This applied to the original samples.)
Was your sample suitable for testing, without contamination?

Answer every question to see your result.

What does participation involve?

You won't directly participate in this study. This study uses leftover, anonymous samples that have already been collected and tested from people aged 18 and over. No new samples are taken from individuals, and no new treatments or visits are involved for anyone. The study is a laboratory comparison, meaning scientists are testing established samples with a new device to see if it works as well or better than current methods. Your medical care will not be affected by this study.

Potential risks and benefits

Since this study uses samples that have already been collected and made anonymous, there are no risks to your health or privacy. No new tests will be done on you, and no medical decisions will be made based on these results for any individual. The main benefit is that, by researching new testing methods, we can help improve how STIs are found in the future, making diagnoses quicker and more accurate for everyone. This could lead to better public health outcomes in the long run.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Randox Clinical Laboratory Services
City only
Antrim, United Kingdom

Common questions

What is an STI-fleX qPCR device?

It's a new testing machine designed to detect several common sexually transmitted infections (STIs) quickly and accurately using a special laboratory technique.

Will I have to give a new sample for this study?

No, this study uses anonymous, leftover samples that have already been collected for routine testing. You will not be asked to provide any new samples.

Does this study involve new medicines or treatments?

No, this study is only about testing a new diagnostic device in a laboratory. It doesn't involve any medicines, treatments, or direct patient care.

How will my privacy be protected?

The study uses samples that have had all personal identifying information removed, making them anonymous. This means your privacy is fully protected.

When will the results of this study be available?

The study started in May 2025, and the testing part is expected to finish within about 60 working days after July 14, 2025. It typically takes some time after that for the results to be fully analysed and published.

How to find out more

Helena Murray

helena.murray@randox.com +44 (0)2894422413 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.