RecruitingObservational

Clinical performance evaluation of a Randox Respiratory-fleX device for respiratory infections

This research is looking at a new medical device called the Randox Respiratory-fleX. It's designed to quickly and accurately spot the germs that cause respiratory (chest, lung, and throat) infections. These infections affect many people, and can be more serious for older individuals or those with other health problems. The study will compare this new device with one currently used to make sure it performs well. If successful, it could help doctors diagnose infections faster and more accurately. Participants aged 18 or over, who are already having tests for a respiratory infection, can take part by allowing their leftover sample to be used. This study helps improve future tests without changing your current medical care.

At a glance

Status

Recruiting

Sponsor

Randox (United Kingdom)

Enrolment target

525

Start

30 Mar 2026

Estimated completion

29 Sep 2027

Detection and discrimination of causative pathogens of respiratory infections.

What is this study about?

Imagine you have a cold or a chesty cough. Doctors need to know quickly what's causing it – is it a common cold virus, the flu, or something more serious, like a bacterial infection? Finding out fast helps them give you the best treatment. This study is testing a new piece of equipment, called the Randox Respiratory-fleX, which is designed to do exactly that: quickly and accurately detect the specific germs (like viruses or bacteria) behind respiratory infections.

Respiratory infections can affect anyone, but they can be especially tricky for older people, those with weaker immune systems, or individuals with conditions like cystic fibrosis. Accurate and speedy diagnosis is vital for these groups to get the right help promptly. The goal of this research is to check if this new device works as well, or even better, than the tests doctors currently use. This includes looking at how accurate it is, how good it is at finding even small amounts of germs, and how quickly it gives results.

Ultimately, if the Randox Respiratory-fleX proves to be effective, it could mean quicker, more reliable results for patients in the future. This could help healthcare professionals make better decisions about treatment, potentially leading to faster recovery and better health outcomes for people with respiratory problems.

Key takeaways

This study tests a new device for faster and more accurate diagnosis of respiratory infections.
It aims to improve future testing methods for conditions like colds, flu, and chest infections.
Participation involves giving consent to use a 'leftover' part of a sample you've already provided for routine testing.
You won't need extra tests or appointments; your medical care will not be affected.
There are no direct risks to you, but your contribution helps advance medical science.
The study focuses on adults aged 18 and over.

Who may be eligible?

You might be able to help with this study if you are 18 years old or older and are already having tests for a respiratory infection. This includes if your doctor suspects you have one, or if you're at a higher risk of getting one, or if you've been around someone with a respiratory bug.

The main thing is that you're already getting a sample (like a swab) taken as part of your routine medical care for a breathing problem. You would need to agree that the 'leftover' part of your sample can be used for 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?
Are you currently suspected of having a respiratory infection?
Are you having a sample taken (like a swab) for routine respiratory testing?
Are you willing to allow a leftover portion of your sample to be used for research?

Answer every question to see your result.

What does participation involve?

If you agree to take part, you won't need to do anything extra or have any additional appointments. The study simply uses a small part of a sample (like a swab) that you've already provided for a routine respiratory infection test through the Randox Testing Service. This is often called a 'leftover' or 'archived' sample.

This study will last for about 18 months, but your involvement is just about giving permission for your sample to be used. Researchers will collect these leftover samples over 12 months. Then, for another 6 months, they will test these samples using both the new Randox Respiratory-fleX device and the standard diagnostic device to compare their performance. You won't hear back about the results of your specific sample from the study, as it's for research purposes only.

Potential risks and benefits

There are no direct personal risks involved in taking part in this study. The study uses leftover samples from tests you've already had, and the results from this research won't affect your medical care or any decisions your doctor makes about your health. The potential benefits are for the wider community and future patients: by participating, you'll be helping researchers evaluate new technology that could lead to faster, more accurate diagnoses of respiratory infections in the future. This could improve how these illnesses are identified and managed for everyone. Remember, your participation is completely voluntary, and you have the right to withdraw your consent to use your sample at any time without it affecting your medical care.

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, Northern Ireland

Common questions

What is a respiratory infection?

It's an infection that affects your airways, like your nose, throat, or lungs. Common examples include colds, flu, bronchitis, and pneumonia.

What is the Randox Respiratory-fleX device?

It's a new machine designed to quickly identify the specific viruses or bacteria causing a respiratory infection from a sample.

Will this study change my medical treatment?

No, absolutely not. The results from this study are for research only and will not be used for your diagnosis or treatment decisions.

Do I need to do anything special to participate?

You just need to be 18 or over, already having a routine respiratory test, and give permission for a small leftover part of your sample to be used for the study.

Who is paying for this research?

The study is funded by Randox Laboratories Ltd, the company developing the new device.

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.