Active not recruitingOBSERVATIONAL

Clinical Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus

This study is looking at how well a new testing device, called QIAstat-Dx® ME Panel Plus, works. This device aims to quickly and accurately check for infections like meningitis and encephalitis. Researchers want to make sure the device gives reliable results when compared to current standard tests. They are also checking that it is safe for the healthcare workers who use it. This is important because getting a quick and accurate diagnosis for these serious conditions can help patients get the right treatment sooner. The study uses existing, leftover fluid samples from patients who have already been tested for meningitis or encephalitis, rather than needing new samples from volunteers.

At a glance

Status

Active not recruiting

Sponsor

QIAGEN Gaithersburg, Inc

Enrolment target

1,500

Start

03 Apr 2025

Estimated completion

01 May 2026

Meningitis Encephalitis Infection

What is this study about?

Imagine you have a serious infection like meningitis or encephalitis. Doctors need to find out quickly what's causing it so they can give you the right treatment. This study is testing a new device called QIAstat-Dx® ME Panel Plus that could help doctors do just that, much faster.

The main aim of this study is to see how accurate and reliable this new device is. Researchers are comparing its results to the results from the usual tests doctors currently use. This helps them confirm that the new device works just as well, if not better, at identifying the specific germs causing these infections. They are also checking that the device is safe for the staff who operate it.

Ultimately, if this new device proves to be accurate and safe, it could mean that people with suspected meningitis or encephalitis get a diagnosis more quickly. This speed can be really important for starting the correct treatment sooner, which could lead to better outcomes for patients. So, this study is all about making sure new medical tools are ready to help patients effectively and safely.

Key takeaways

This study is evaluating a new device for quickly diagnosing serious brain and spinal cord infections.
The device aims to improve how doctors find out if someone has meningitis or encephalitis.
No new patient samples are being collected; only existing, leftover samples are used.
Patient privacy is protected as all samples are anonymous.
If successful, this device could lead to faster and more accurate diagnoses in the future.

Who may be eligible?

This study isn't asking for volunteers to provide new samples. Instead, it uses existing leftover fluid samples that were already collected from patients who were being checked for meningitis or encephalitis.

For a sample to be included, it must be spinal fluid that was taken during a procedure called a lumbar puncture. These samples are 'leftover' – meaning they are remaining after all necessary tests for the patient have been completed, and any identifying information about the patient has been removed to protect their privacy.

The samples also need to meet certain storage conditions, like being kept at specific temperatures, and must not have been frozen and thawed too many times. Some samples might be from recent patients, while others might be older samples that were stored because they had already been confirmed to have certain viruses linked to meningitis or encephalitis.

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.

Did I have a lumbar puncture (spinal tap) for suspected meningitis or encephalitis?
Was a leftover sample of my spinal fluid saved for research?
Was my personal information removed from the sample before it was used?
Was my sample stored correctly before being tested in the study?

Answer every question to see your result.

What does participation involve?

This study does not involve patients directly. Instead, it uses existing, leftover fluid samples from patients who have already had them taken as part of their regular medical care. Therefore, there are no required visits, assessments, medications, or follow-up for patients. You would not be asked to do anything if you were a patient whose leftover sample was used, nor would you be aware of it, as all samples are de-identified (personal information removed). The duration refers to the time researchers take to test the samples.

Potential risks and benefits

Since this study only uses leftover, anonymous samples from patients that have already been collected for medical reasons, there are no direct risks or benefits to individual patients. The potential benefit is that, if successful, the new testing device could help doctors diagnose meningitis and encephalitis more quickly and accurately in the future, which could lead to better patient care. As patients are not directly involved, there is no right to withdraw from the study.

Locations (1)

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

QIAGEN
Verified postcode
Manchester, United Kingdom

Common questions

What is meningitis?

Meningitis is a serious inflammation around the brain and spinal cord, often caused by an infection.

What is encephalitis?

Encephalitis is a serious inflammation of the brain itself, usually caused by an infection.

What is a lumbar puncture?

A lumbar puncture (sometimes called a spinal tap) is a medical procedure to collect a small amount of fluid from around your spinal cord for testing.

Is this study looking for new patient volunteers?

No, this study only uses leftover fluid samples that were collected from patients as part of their previous medical care.

Will my personal data be used?

No, all samples used in the study have had personal identifying information removed to protect patient privacy.