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

Qiagen

Status: Completed

Conditions: Meningitis/Encephalitis

Study type: Observational

Funder types: Industry

Identifiers

NCT05092438

SMF-DHF-18-0489-001

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: 595 patients

Sex: All

Volunteers: No 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