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

NCT05783947 | Completed

• 1 other identifier: 23-5024
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Paraneoplastic Neurological Syndrome; Autoimmune Encephalitis

Keywords

autoantibodies; diagnostic; paraneoplastic; encephalitis; neuronal

Outcome Measures

Primary Outcomes (1)

• Number of discrepant results between commercial and in-house assays

  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.

  at the baseline

Study Arms (1)

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

Interventions

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

Suspicion of autoimmune neurological disorder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hospice Civils de Lyon

Bron, 69500,, France

Location

Hospices Civils de Lyon

Pierre-Bénite, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and CSF

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System; Disease; Encephalitis

Condition Hierarchy (Ancestors)

Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Jérome HONNORAT, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: March 1, 2021
• Primary Completion: July 15, 2021
• Study Completion: February 28, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)