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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03895281

Enrollment

150

Registered

2019-03-29

Start date

2019-04-01

Completion date

2020-04-30

Last updated

2019-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningitis/Encephalitis

Brief 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.

Interventions

DIAGNOSTIC_TESTFilmArray 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical sensitivity and specificity of the FilmArray ME Panel	6 days upon sample collection	Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay

Contacts

Primary ContactQing Cao, MD

caoqing@scmc.com.cn+86 18930830511

Backup ContactYue Tao, PhD

taoyue@scmc.com.cn+86 15121067906

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026