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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Meningitis/Encephalitis

Treatments: Diagnostic Test: FilmArray Meningitis/Encephalitis (ME) Panel

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03895281

SCMC-ME

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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