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

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 o…