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COMPLETEDNCT05155553

QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study

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

Lead sponsor: QIAGEN Gaithersburg, Inc•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

QIAGEN Gaithersburg, Inc

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

Age

All ages

Sex

ALL

Healthy Volunteers

No

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

•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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 17, 2024Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment1,524

Start dateMay 2022

Last updatedOct 17, 2024

Condition

Meningitis/Encephalitis

Locations shown

Qiagen

Manchester

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2024Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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