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

Autoimmune Encephalitis Clinical Trial

— IFINEURO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05783947
• Other study ID #: 23-5024
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 28, 2022
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

• 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

Related Conditions & MeSH terms

• Autoimmune Encephalitis
• Encephalitis
• Paraneoplastic Neurological Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Hospice Civils de Lyon	Bron
France	Hospices Civils de Lyon	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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