QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study

Qiagen

Status: Completed

Conditions: Meningitis/Encephalitis

Treatments: Device: QIAstat-Dx® Meningitis/Encephalitis (ME) Panel

Study type: Observational

Funder types: Industry

Identifiers

NCT05155553

SMF-DHF-18-0489-002

Details and patient eligibility

About

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

Full description

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

Enrollment: 1,524 patients

Sex: All

Volunteers: No Healthy Volunteers

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.