ClinicalTrials.gg
Sign In
CompletedNCT05155553Updated Oct 17, 2024

QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study

An observational study in Meningitis/Encephalitis, sponsored by QIAGEN Gaithersburg, Inc. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2024-10-17.

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

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,524
Sex
All
01

Study summary

Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.

Read the detailed description

This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.

02

Conditions studied

  • Meningitis/Encephalitis
03

In context

Meningitis

381 studies on the registry are indexed under Meningitis; 33 are open to participants now.

This study's enrollment of 1,524 is above the median of 346 across 98 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
Probability sample

Study population

Subjects (adults and children) with signs and symptoms of meningitis and/or encephalitis

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

  • Residual specimens (minimum 500μL) of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing Specimen that have not undergone more than 3 freeze/thaw cycles.

Exclusion criteria

Exclusion Criteria:

  • Specimens not fitting criteria outlined above.
  • CSF obtained from an external ventricular drain or shunt source.
  • Lack of clear subject identification or label on residual banked CSF specimen.
  • Specimen has been centrifuged.
  • Obvious physical damage of banked residual specimen.
  • Repeat specimens from the same subject.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,524 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • DeviceQIAstat-Dx® Meningitis/Encephalitis (ME) Panel

    The performance of QIAstat-Dx® Meningitis/Encephalitis Panel will be evaluated in comparison with another validated comparator method, followed by bidirectional sequencing using residual specimens of cerebrospinal fluid (CSF) obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis.

06

What researchers measure

Primary outcomes

  1. PPA

    positive percentage agreement

    Time frame: 6 months

  2. NPA

    negative percentage agreement

    Time frame: 6 months

07

Study locations

1 site
  • Qiagen
    Manchester, United Kingdom
08

References and documents

Individual participant data

Plan to share: No — all samples are residual and anonymized

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05155553
Lead sponsor
QIAGEN Gaithersburg, Inc
Responsible party
Sponsor
First posted
Dec 13, 2021
Start date
May 4, 2022
Primary completion
Mar 2, 2023
Completion
Mar 2, 2023
Last update
Oct 17, 2024

Study contacts

Sarah Johnson
study director · QIAGEN Gaithersburg, Inc

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

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.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Meningitis →

Other studies from this sponsor

QIAGEN Gaithersburg, Inc →

Start the discussion