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

NCT03895281 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2019-03-29

No results posted yet for this study

Summary

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.

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

  • BioMérieux

    collaborator INDUSTRY

  • Shanghai Children's Medical Center

    lead OTHER

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-12-31
Completion
2020-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03895281 on ClinicalTrials.gov