Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT06820060
Eligibility Criteria:
Inclusion Criteria:
* 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:
* -15 ºC to -25 ºC for ≤ 2 months
* -60 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.
* Prospective Samples Only: Specimen must have been collected on or after the date of prospective study activation at the Clinical collection and testing site.
* Retrospective Samples Only: Specimens must have a positive diagnosis as per Standard of Care for any of the following viral targets:
Herpes simplex virus 1 (HSV-1) Herpes simplex virus 2 (HSV-2) Human herpesvirus 6 (HHV-6) Human parechovirus (HPeV) Varicella zoster virus (VZV) Cytomegalovirus (CMV)
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06820060
Study Brief:
Protocol Section:
NCT06820060