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

An Observational, Prospective and Retrospective Clinical Study to Evaluate the Performance of QIAstat-Dx® Meningitis/Encephalitis (ME) Panel Plus During Normal Conditions of Use

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

The objective of the study is 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.

The primary objective is to evaluate the performance of QIAstat-Dx® ME Panel Plus in comparison with the results obtained from the reference method.

The secondary objective of the study is to evaluate the safety of QIAstat-Dx® ME Panel Plus with respect to users/operators.

The primary study endpoint will be the results for each analyte obtained from testing prospective and retrospective specimens with QIAstat-Dx® ME Panel Plus and Reference Method. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be determined

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.