Detection of Antibodies against the Acetylcholine Receptor in Patients with Myasthenia Gravis: A Comparison of Two Enzyme Immunoassays and a Fixed Cell-Based Assay

Author:

Gambino Caterina Maria12,Agnello Luisa1,Ciaccio Anna Maria3,Scazzone Concetta1,Vidali Matteo4ORCID,Di Stefano Vincenzo5ORCID,Milano Salvatore2,Brighina Filippo5ORCID,Candore Giuseppina12ORCID,Lo Sasso Bruna12,Ciaccio Marcello12ORCID

Affiliation:

1. Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Clinical Laboratory Medicine, University of Palermo, 90127 Palermo, Italy

2. Department of Laboratory Medicine, University Hospital “P. Giaccone”, 90127 Palermo, Italy

3. Department of Health Promotion, Maternal and Infant Care, Internal Medicine and Medical Specialties “G. D’Alessandro”, University of Palermo, 90127 Palermo, Italy

4. Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy

5. Department of Biomedicine, Neurosciences and Advanced Diagnostics, Unit of Neurology, University of Palermo, 90127 Palermo, Italy

Abstract

The detection of serum anti-acetylcholine receptor (AChR) antibodies is currently an important tool for diagnosing myasthenia gravis (MG) since they are present in about 85% of MG patients. Many serological tests are now available. Nevertheless, results from these tests can be different in some patients. The aim of this study is to compare the sensitivity of a commercially available fixed cell-based assay (F-CBA) to that of enzyme-linked immunosorbent assay (ELISA) kits for anti-AChR detection in patients with a diagnosis of MG. Overall, 143 patients with a confirmed MG diagnosis were included in the study. The detection and measurement of serum anti-AChR antibodies were performed by three analytical methods, namely, a competitive ELISA (cELISA), an indirect ELISA (iELISA), and an F-CBA, according to the manufacturers’ instructions. Anti-AChR antibody titers were positive in 94/143 (66%) using the cELISA, in 75/143 (52%) using the iELISA and in 61/143 (43%) using the F-CBA (adult and/or fetal). Method agreement, evaluated by concordant pairs and Cohen’s kappa, was as follows: cELISA-iELISA: 110/143 (77%), k = 0.53 (95%CI 0.40–0.66); cELISA-F-CBA: 108/143 (76%), k = 0.53 (95%CI 0.41–0.66); iELISA-F-CBA: 121/143 (85%), k = 0.70 (95%CI 0.57–0.80). Our findings show that the cELISA has better analytical performance than the iELISA and F-CBA. However, the iELISA and F-CBA show the highest concordance.

Publisher

MDPI AG

Subject

General Medicine

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