QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study

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

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

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

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.