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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Meningitis/Encephalitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Cao Qing

Director of Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Qing Cao, MD

Role: CONTACT

Phone: +86 18930830511

Email: [email protected]

Yue Tao, PhD