Diagnostic Performance of a Commercial Assay for the Detection of Neuronal Antibodies
IFINEURO
IFINEURO
Sponsor study identifier
observational
34
1 country
2
Study Start
March 1, 2021
Actual (reported)Primary Completion
July 15, 2021
Actual (reported)Study Completion
February 28, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2021
Actual (reported)July 15, 2021
Actual (reported)February 28, 2022
Actual (reported)March 13, 2023
Actual (reported)March 24, 2023
Actual (reported)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
Sera and CSF of patients with a suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome
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.
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Patients with a suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome
Contact the study team to confirm eligibility.
Hospice Civils de Lyon
Bron, 69500,, France
Hospices Civils de Lyon
Pierre-Bénite, France
serum and CSF
Jérome HONNORAT, PhD
Hospices Civils de Lyon
34 participants (actual enrollment reported by the registry).
First Submitted
March 13, 2023
First Posted
March 24, 2023
Study Start
March 1, 2021
Actual (reported)Metabolic Imaging for Diagnosis and Prognostication of Autoimmune encephalitiS
Primary Completion
July 15, 2021
Actual (reported)Study Completion
February 28, 2022
Actual (reported)Last Updated
March 24, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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