Active — Not RecruitingNot Applicable

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

United Kingdom1,500 participantsStarted 2025-04-03

Plain-language summary

Performance evaluation of QIAstat-Dx® ME Panel Plus using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® ME Panel Plus achieves its intended performance during normal conditions of use by the intended user in the intended environment

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Specimen must be Cerebrospinal fluid, obtained via lumbar puncture only. * Specimen must be a de-identified residual leftover specimen. * Specimen must meet the laboratory testing criteria for individuals with signs and/or symptoms of meningitis and/or encephalitis. * Specimens must have a minimum 450 µL of residual volume. * Specimen must be unique (only one sample enrolled per patient). * Prior to QIAstat-Dx testing, residual CSF specimen must have been stored in accordance with the following: * Prospective Fresh: * Room temperature (15 °C to 25 °C) for ≤24 hrs * Refrigerated (2 °C to 8 °C) for ≤ 7 days * Prospective Frozen: * -15 ºC to -25 ºC for ≤ 2 months * -60 ºC to -90 ºC for ≤ 4 months * Retrospective Archived: * Frozen * At the time of QIAstat-Dx testing, specimen must not have undergone more than three (3) freeze/thaw cycles. * Prospective Samples Only: Specimen must have been collected on or after the date of prospective study activation at the Clinical collection and testing site. * Retrospective Samples Only: Specimens must have a positive diagnosis as per Standard of Care for any of the following viral targets: Herpes simplex virus 1 (HSV-1) Herpes simplex virus 2 (HSV-2) Human herpesvirus 6 (HHV-6) Human parechovirus (HPeV) Varicella zoster virus (VZV) Cytomegalovirus (CMV) Exclusion Criteria: * Residual CSF specimen has been centrifuged. * Residual CSF specimen subject identification or label is unclear o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PPA

Timeframe: 7 months

NPA

Timeframe: 7 months

Trial details

NCT IDNCT06820060

SponsorQIAGEN Gaithersburg, Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-01-15

View on ClinicalTrials.gov More Meningitis trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.