QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study

Meningitis/Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05155553
• Other study ID #: SMF-DHF-18-0489-002
• Status: Active, not recruiting
• Start date: May 6, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2023
• Source: QIAGEN Gaithersburg, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1600
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Encephalitis
• Meningitis
• Meningitis/Encephalitis

Intervention

Device:
• QIAstat-Dx® Meningitis/Encephalitis (ME) Panel
The performance of QIAstat-Dx® Meningitis/Encephalitis Panel will be evaluated in comparison with another validated comparator method, followed by bidirectional sequencing using residual specimens of cerebrospinal fluid (CSF) obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis.

Locations

Country	Name	City	State
United Kingdom	Qiagen	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
QIAGEN Gaithersburg, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PPA	positive percentage agreement	6 months
Primary	NPA	negative percentage agreement	6 months