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

March 9, 2026 updated by: QIAGEN Gaithersburg, Inc

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

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with signs and symptoms of Meningitis/Encephalitis infection

Description

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 or missing.
  • Residual CSF specimen container has obvious physical damage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PPA
Time Frame: 7 months
Positive percent agreement
7 months
NPA
Time Frame: 7 months
Negative percent agreement
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QIAGEN Gaithersburg, Inc

Investigators

  • Principal Investigator: Sarah Johnson, Qiagen Manchester Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHF-18-0489-1-CSP-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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