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

Civil Hospices of Lyon

Status: Completed

Conditions: Paraneoplastic Neurological Syndrome; Autoimmune Encephalitis

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

Study type: Observational

Funder types: Other

Identifiers

NCT05783947

23-5024

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

34 participants in 1 patient group

Suspicion of autoimmune neurological disorder

Description:

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

Treatment:

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