MeningitisNCT06820060
Clinical Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus
An observational study of Meningitis and Encephalitis Infection, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meningitis, Encephalitis Infection
- How many people
- 1,500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with signs and symptoms of Meningitis/Encephalitis infection
Who may be able to join
- 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:
Show all 18Show fewer
- 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)
Who cannot join
- Residual CSF specimen has been centrifuged.
- Residual CSF specimen subject identification or label is unclear or missing.
- Residual CSF specimen container has obvious physical damage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational, Prospective and Retrospective Clinical Study to Evaluate the Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus During Normal Conditions of Use
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
Read the detailed description
The objective of the study is 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.
The primary objective is to evaluate the performance of QIAstat-Dx® ME Panel Plus in comparison with the results obtained from the reference method.
The secondary objective of the study is to evaluate the safety of QIAstat-Dx® ME Panel Plus with respect to users/operators.
The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® ME Panel Plus and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined
- Conditions
- Meningitis, Encephalitis Infection
- Keywords
- Meningitis infection, QIAstat-Dx, Clinical Performance Study, Encephalitis infection
- Medical subject headings
- Meningitis, Infectious Encephalitis
What is being measured
The primary outcome is the main question the study is designed to answer.
PPA
Positive percent agreement
Measured: 7 months
NPA
Negative percent agreement
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start3 Apr 2025
- Primary completion15 May 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Principal investigator, Qiagen Manchester Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820060
- Sponsor's protocol ID
- DHF-18-0489-1-CSP-003
- Status last verified
- Jul 2026
- First submitted
- 5 Feb 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective and Retrospective Clinical Study to Evaluate the Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus During Normal Conditions of Use
- ClinicalTrials.gov ID
- NCT06820060
- Acronym / sponsor ID
- DHF-18-0489-1-CSP-003
- Conditions
- Meningitis, Encephalitis Infection
- Keywords
- Meningitis infection, QIAstat-Dx, Clinical Performance Study, Encephalitis infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The objective of the study is 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.
The primary objective is to evaluate the performance of QIAstat-Dx® ME Panel Plus in comparison with the results obtained from the reference method.
The secondary objective of the study is to evaluate the safety of QIAstat-Dx® ME Panel Plus with respect to users/operators.
The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® ME Panel Plus and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with signs and symptoms of Meningitis/Encephalitis infection
Key inclusion criteria (18 listed)
- 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).
Key exclusion criteria (3 listed)
- Residual CSF specimen has been centrifuged.
- Residual CSF specimen subject identification or label is unclear or missing.
- Residual CSF specimen container has obvious physical damage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PPA
Time frame: 7 months
Positive percent agreement
NPA
Time frame: 7 months
Negative percent agreement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Johnson principal investigator
Qiagen Manchester Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis and Encephalitis Infection, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPA (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.