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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT05783947

Collaborator

(none)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Paraneoplastic Neurological Syndrome Autoimmune Encephalitis	Diagnostic Test: Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or sera

Study Design

Study Type:

Observational

Actual Enrollment :

34 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Diagnostic Performance of a Commercial Indirect Immunofluorescence Assay for the Detection of Neuronal Antibodies in Auto-immune Encephalitis and Paraneoplastic Neurological Syndromes

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Jul 15, 2021

Actual Study Completion Date :

Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Suspicion of autoimmune neurological disorder Sera and CSF of patients with a suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome	Diagnostic Test: 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.

Arm

Intervention/Treatment

Suspicion of autoimmune neurological disorder

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

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures

Number of discrepant results between commercial and in-house assays [at the baseline]
Both in-house and commercial assays will be performed independently and results will be compared once all tests are done. Number of discrepant results will be compared with concordant results according to the autoantibody identified.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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