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

UnknownOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

April 1, 2019

Primary Completion Date

December 31, 2019

Study Completion Date

April 30, 2020

Conditions
Meningitis/Encephalitis
Interventions
DIAGNOSTIC_TEST

FilmArray Meningitis/Encephalitis (ME) Panel

The FilmArray ME pouch is a closed system disposable that houses all the chemistry required to isolate, amplify and detect nucleic acid from multiple meningitis and encephalitis pathogens within a single CSF specimen obtained from a lumbar puncture. The rigid plastic component (fitment) of the FilmArray ME pouch contains reagents in freeze-dried form. The flexible plastic portion of the pouch is divided into discrete segments (blisters) where the required chemical processes are carried out. The user of the FilmArray ME Panel loads the sample into the FilmArray ME pouch, places the pouch into the FilmArray instrument/Module, and starts the run. All other operations are automated.

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BioMérieux

INDUSTRY

lead

Shanghai Children's Medical Center

OTHER

NCT03895281 - Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel | Biotech Hunter | Biotech Hunter