Diagnostic Performance of a Commercial Assay for the Detection of Neuronal Antibodies

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

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-02-28

Brief Summary

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Detection of autoantibodies targeting neuronal surface or intracellular antigens is a keystone for the diagnosis and the treatment of auto-immune encephalitis and paraneoplastic neurological syndromes. A strategy commonly used for their detection is to perform a screening with a tissue-based immunofluorescence assay or immunohistochemistry assay and a second line test to confirm and identify the autoantibody. Since several years, commercial kits are used by a growing number of laboratories to screen the presence of these autoantibodies. However, the diagnostic performance of these commercial kits is highly variable and several studies reported a high prevalence of false-positive and false-negative results with commercial immunodots and cell-based assays. It is therefore essential to explore commercial kits limitations in order to avoid false-positive and false-negative results that could lead to misdiagnosis and/or to delay the treatments.

To assess the diagnostic performance of commercial kits, the investigators performed a prospective study in which the investigators screened patients neuronal autoantibodies in cerebrospinal fluid and sera using commercial tissue-based indirect immunofluorescence assay and CBAs in comparison with an in-house tissue-based indirect immunofluorescence assay.

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Detailed Description

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Conditions

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Paraneoplastic Neurological Syndrome Autoimmune Encephalitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Suspicion of autoimmune neurological disorder

Sera and CSF of patients with a suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome

Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or sera

Intervention Type DIAGNOSTIC_TEST

Sera and/or CSF samples are drawn from patients with a clinical suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome. Indirect immunofluorescence assays will be performed on commercial and in-house slides upon receipt in our center. In case of positive staining, additional tests such as cell-based assays, western-blots, ELISA or immunodots can be performed.

Interventions

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Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or sera

Sera and/or CSF samples are drawn from patients with a clinical suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome. Indirect immunofluorescence assays will be performed on commercial and in-house slides upon receipt in our center. In case of positive staining, additional tests such as cell-based assays, western-blots, ELISA or immunodots can be performed.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Inclusion Criteria \* : Sera and/or CSF with sufficient volume to perform both in-house and commercial assays
* Exclusion Criteria \* : Sera and/or CSF with insufficient volume to perform both in-house and commercial assays

Eligible Sex

ALL

Accepts Healthy Volunteers

No