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

Completed

• Conditions: Autoimmune Encephalitis; Paraneoplastic Neurological Syndrome
• Interventions: Diagnostic Test: Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or sera

• Registration Number: NCT05783947
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-07-15
• Study Completion: 2022-02-28
• Status Verified: 2023-03
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-24
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspicion of autoimmune neurological disorder	Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or sera	Sera and CSF of patients with a suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France

Hospice Civils de Lyon; 🇫🇷 Bron, France