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Completed

NCT Number: NCT05155553

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.

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Key information

Conditions

Meningitis/Encephalitis Brain Diseases Central Nervous System Diseases Encephalitis Meningitis Nervous System Diseases Neuroinflammatory Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Qiagen

Manchester, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QIAstat-Dx® Meningitis/Encephalitis (ME) Panel

Device

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.

Primary outcomes

  1. PPA

    Time frame: 6 months

    positive percentage agreement

  2. NPA

    Time frame: 6 months

    negative percentage agreement

Sponsors and collaborators

Lead sponsor

QIAGEN Gaithersburg, Inc

Industry

Registry information

Official study title

An Observational Clinical Performance Evaluation Study Testing Residual Specimens of Cerebrospinal Fluid Obtained by Lumbar Puncture From Meningitis/Encephalitis Subjects Using the QIAstat-Dx® Meningitis/Encephalitis Panel

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2021
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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