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| Name | Class |
|---|---|
| BioMérieux | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FilmArray Meningitis/Encephalitis (ME) Panel | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical sensitivity and specificity of the FilmArray ME Panel | Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay | 6 days upon sample collection |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with signs and/or symptoms of meningitis and/or encephalitis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Cao, MD | Contact | +86 18930830511 | caoqing@scmc.com.cn | |
| Yue Tao, PhD | Contact | +86 15121067906 | taoyue@scmc.com.cn |
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| ID | Term |
|---|---|
| D008581 | Meningitis |
| D004660 | Encephalitis |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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