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Completed

NCT Number: NCT05092438

QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study 001

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 of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing
  • Specimen that had not been centrifuged Adequate residual volume (≥400 μl)

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
  • Obvious physical damage of banked residual specimen
  • Repeat specimens from the same subject

Treatment and study plan

Primary outcomes

  1. sensitivity

    Time frame: 6 weeks

    positive percentage agreement

  2. specificity

    Time frame: 6 weeks

    negative percentage agreement

Sponsors and collaborators

Lead sponsor

QIAGEN Gaithersburg, Inc

Industry

Registry information

Official study title

An Observational, Retrospective, Clinical Performance 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
2021
Primary completion
2021
Study completion
2021
First posted
Oct 25, 2021
Registry last updated
Apr 16, 2025

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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