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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05092438

Enrollment

595

Registered

2021-10-25

Start date

2021-10-08

Completion date

2021-12-02

Last updated

2025-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningitis/Encephalitis

Brief summary

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

Detailed description

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
sensitivity	6 weeks	positive percentage agreement
specificity	6 weeks	negative percentage agreement

Countries

United Kingdom

Outcome results