Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel

Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel

The FilmArray Meningitis/Encephalitis (ME) Panel (hereinafter referred to as FilmArray ME Panel) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.

Inclusion Criteria:

• Residual cerebrospinal fluid samples after routine tests;
• Samples obtained by lumbar puncture;
• Sample volume is not less than 0.5 mL;
• Samples that have not been centrifuged;

Exclusion Criteria:

• Samples from repeatedly enrolled patients;
• Samples that have not been preserved as required