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Active, not recruitingNCT06820060Updated Jul 31, 2026

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

An observational study in Meningitis and Encephalitis Infection, sponsored by QIAGEN Gaithersburg, Inc. Active, not recruiting at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by QIAGEN Gaithersburg, Inc (part of QIAGEN) · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,500
Sex
All
01

Study 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 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

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Conditions studied

  • Meningitis
  • Encephalitis Infection

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Keywords

  • Meningitis infection
  • QIAstat-Dx
  • Clinical Performance Study
  • Encephalitis infection
03

In context

Meningitis

268 studies on the registry are indexed under Meningitis; 28 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 535 across 64 observational studies indexed under Meningitis.

Browse Meningitis studies →

Lead sponsor

QIAGEN Gaithersburg, Inc is the lead sponsor of 27 studies on the registry; 1 is open to participants now.

First submitted after QIAGEN Gaithersburg, Inc became part of QIAGEN.

Browse QIAGEN Gaithersburg, Inc studies →All QIAGEN studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with signs and symptoms of Meningitis/Encephalitis infection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. PPA

    Positive percent agreement

    Time frame: 7 months

  2. NPA

    Negative percent agreement

    Time frame: 7 months

07

Study locations

1 site
  • QIAGEN
    Manchester, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2025 to primary completion in May 2026, 13 months.

Of 29 observational studies under Meningitis, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 96. This study's 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2025
First posted
Feb 11, 2025
StartActual
Apr 3, 2025
Primary completionActual
May 15, 2026
CompletionEst.
Oct 2026
Last update
Jul 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06820060
Lead sponsor
QIAGEN Gaithersburg, Inc
Responsible party
Sponsor
First posted
Feb 11, 2025
Start date
Apr 3, 2025
Primary completion
May 15, 2026
Completion
Oct 2026 (estimated)
Last update
Jul 31, 2026

Study contacts

Sarah Johnson
principal investigator · Qiagen Manchester Limited

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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