NCT05783947

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-07-15
• Completion: 2022-02-28
• First posted: 2023-03-24
• Last updated: 2023-03-24

Locations

2 sites across 1 country: France