Clinical Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus

NCT06820060 | Active Not Recruiting

• 1 other identifier: DHF-18-0489-1-CSP-003
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Performance evaluation of QIAstat-Dx® ME Panel Plus using the QIAstat-Dx® Analyzer to demonstrate that the QIAstat-Dx® ME Panel Plus achieves its intended performance during normal conditions of use by the intended user in the intended environment

Conditions

Meningitis; Encephalitis Infection

Keywords

Meningitis infection; QIAstat-Dx; Clinical Performance Study; Encephalitis infection

Outcome Measures

Primary Outcomes (2)

• PPA

  Positive percent agreement

  7 months

• NPA

  Negative percent agreement

  7 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with signs and symptoms of Meningitis/Encephalitis infection

You may qualify if:

• Specimen must be Cerebrospinal fluid, obtained via lumbar puncture only.
• Specimen must be a de-identified residual leftover specimen.
• Specimen must meet the laboratory testing criteria for individuals with signs and/or symptoms of meningitis and/or encephalitis.
• Specimens must have a minimum 450 µL of residual volume.
• Specimen must be unique (only one sample enrolled per patient).
• Prior to QIAstat-Dx testing, residual CSF specimen must have been stored in accordance with the following:
• Prospective Fresh:
• Room temperature (15 °C to 25 °C) for ≤24 hrs
• Refrigerated (2 °C to 8 °C) for ≤ 7 days
• Prospective Frozen:
• ºC to -25 ºC for ≤ 2 months
• ºC to -90 ºC for ≤ 4 months
• Retrospective Archived:
• Frozen
• At the time of QIAstat-Dx testing, specimen must not have undergone more than three (3) freeze/thaw cycles.

You may not qualify if:

• Residual CSF specimen has been centrifuged.
• Residual CSF specimen subject identification or label is unclear or missing.
• Residual CSF specimen container has obvious physical damage.

Sponsors & Collaborators

• QIAGEN Gaithersburg, Inc: lead

Study Sites (1)

QIAGEN

Manchester, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fresh Cerebrospinal specimens Selected archived frozen specimens will be tested retrospectively if required.

MeSH Terms

Conditions

Meningitis; Infectious Encephalitis

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Central Nervous System Infections; Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases

Study Officials

• Sarah Johnson

  Qiagen Manchester Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: April 3, 2025
• Primary Completion: January 15, 2026
• Study Completion: May 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-04

Locations

GB (1)