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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-03

Study Completion Date

2026-03-31

Brief Summary

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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

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Detailed Description

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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

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Encephalitis Infection Meningitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No