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J Immunol Res. 2014;2014:405956. doi: 10.1155/2014/405956. Epub 2014 Mar 5.

Analysis of autoantibodies to 3-hydroxy-3-methylglutaryl-coenzyme A reductase using different technologies.

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Department of Immunology, Université Pierre et Marie Curie (AP-HP) Pitié-Salpêtrière Hospital, Paris, France.
Institute for Specialized Medicine, 4125 Sorrento Valley Blvd Suite A, Del Mar, San Diego, CA 92121, USA.
Inserm, U905 & Normandie University, IRIB, 76000 Rouen, France ; Department of Immunology, Rouen University Hospital, 76000 Rouen, France.
Department of Research, INOVA Diagnostics, INC., 9900 Old Grove Road, San Diego, CA 92131-1638, USA.
Departments of Neurology and Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.


Diagnostic tests are needed to aid in the diagnosis of necrotizing myopathies associated with statin use. This study aimed to compare different technologies for the detection of anti-HMGCR antibodies and analyze the clinical phenotype and autoantibody profile of the patients. Twenty samples from myositis patients positive for anti-HMGCR antibodies using a research addressable laser bead assay and 20 negative controls were tested for autoantibodies to HMGCR: QUANTA Lite HMGCR ELISA and QUANTA Flash HMGCR CIA. All patients were also tested for antibodies to extractable nuclear antigens and myositis related antibodies. To verify the specificity of the ELISA, 824 controls were tested. All three assays showed qualitative agreements of 100% and levels of anti-HMGCR antibodies showed significant correlation: Spearman's rho > 0.8. The mean age of the anti-HMGCR antibody positive patients was 54.4 years, 16/20 were females, and 18/20 had necrotizing myopathy (two patients were not diagnosed). Nine out of 20 anti-HMGCR positive patients were on statin. All patients with anti-HMGCR antibodies were negative for all other autoantibodies tested. Testing various controls showed high specificity (99.3%). Anti-HMGCR antibodies are not always associated with the use of statin and appear to be the exclusive autoantibody specificity in patients with statin associated myopathies.

[Indexed for MEDLINE]
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