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High-Throughput Immunoassays for Cavin-4 IgG: A Diagnostic Tool for Immune-Mediated Rippling Muscle Disease
Reghann G LaFrance-Corey1, Haidara Kherbek1,2, Nimalan Harinesan1,2
1Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
Insights
A new cavin-4 protein ELISA shows high accuracy for diagnosing immune-mediated rippling muscle disease (iRMD). This assay is a promising tool for efficient clinical testing of iRMD patients.
Area of Science:
- Immunology
- Neurology
- Biochemistry
Background:
- Immune-mediated rippling muscle disease (iRMD) is a rare condition.
- Cavin-4 has been identified as a potential autoantigen in iRMD.
- Accurate diagnostic tools for iRMD are needed.
Purpose of the Study:
- To validate cavin-4 as an autoantigen for iRMD.
- To develop and compare the diagnostic performance of various immunoassays for iRMD.
- To assess the clinical utility of a cavin-4 protein ELISA for iRMD diagnosis.
Main Methods:
- Development and testing of a cell-based assay (CBA), cavin-4 recombinant protein ELISA, and multi-peptide ELISA.
- Evaluation of diagnostic performance (sensitivity and specificity) in 19 iRMD patients.
- Analysis of clinical and analytical specificities for each assay.
Main Results:
- All immunoassays demonstrated high clinical and analytical specificities (>95%).
- The cavin-4 protein ELISA exhibited the highest sensitivity (94.7%) and specificity (99.9%).
- The protein ELISA outperformed CBA (94.7% vs 89.5% sensitivity) and multi-peptide ELISA (94.7% vs 79.0% sensitivity).
Conclusions:
- Cavin-4 is a validated autoantigen for iRMD.
- The cavin-4 protein ELISA is a highly sensitive and specific diagnostic tool for iRMD.
- This ELISA assay holds promise for high-throughput clinical testing in iRMD.
Abstract:
Cavin-4 was identified as a potential autoantigen for immune-mediated rippling muscle disease (iRMD). To validate this, we developed and tested various immunoassays, including a cell-based assay (CBA), cavin-4 recombinant protein ELISA, and multi-peptide ELISA. Among 19 iRMD patients, all exhibited muscle rippling, and 13 had percussion-induced mounding. All immunoassays demonstrated clinical and analytical specificities greater than 95%. The protein ELISA had the highest sensitivity (94.7%) and specificity (99.9%), outperforming CBA (sensitivity 89.5%, specificity 99.6%) and the multi-peptide ELISA (sensitivity 79.0%, specificity 97.2%). Our results suggest that the cavin-4 protein ELISA is a promising tool for high-throughput clinical testing in iRMD.
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