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Inter-laboratory comparison of routine autoantibody detection methods for autoimmune neuropathies and myasthenia gravis

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Abstract

Serological tests are important to detect autoantibodies (autoAbs) in patients with autoimmune neuropathies (AN) and myasthenia gravis (MG) as they are biomarkers for diagnosis, stratification, treatment selection, and monitoring. However, tests to detect autoAbs frequently lack proper standardization and results differ across diagnostic laboratories. We compared results for tests routinely performed in Spanish diagnostic laboratories to detect AN and MG autoAbs. In the Spanish Society of Immunology Autoimmunity Group national workshop, serum samples from 13 patients with AN or MG were tested for anti-ganglioside, anti-myelin-associated glycoprotein (MAG), anti-nicotinic acetylcholine receptor (AChR), and anti-muscle-specific kinase (MuSK) autoAbs using reference methods and were distributed for analysis to 27 participating laboratories using their routine methods. Overserved were inter-laboratory variability and worryingly low sensitivity, especially for anti-ganglioside immunoglobulin G and anti-MAG autoAb detection. This pilot study reflects autoAbs detection state of the art in AN and MG testing in leading diagnostic laboratories in Spain, highlighting the need for standardization prior to clinical use.

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Data availability

The data of this work are not openly available to protect study participant privacy but anonymized data are available from the corresponding author upon reasonable request.

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Acknowledgements

To the patients who agreed to participate in this workshop. To the technical team and the interns of the immunology department of the HSCSP who helped prepare the samples for shipment to 2. The participating laboratories. To all the participating laboratories: H.U. Basurto, Bilbao (María Imaz); H.U. Clínic, Barcelona (Raquel Ruiz); CATLAB, Viladecavalls (Mireia Fonolleda); H.U. de Badajoz, Badajoz (Mª Luisa Vargas); H.U. son Espases, Palma de Mallorca (Mª Rosa Julià, Sara Sánchez); H.U. Gregorio Marañón, Madrid (Paloma Sánchez-Mateos); H.U. Donostia, San Sebastián (Alvaro Prada, David Monzón); H.U. Virgen Macarena, Sevilla (Concepción González); H.U. Germans Trias i Pujol, Badalona (Joan Climent, Eva Martínez-Cáceres); Clínica Universitaria de Navarra, Pamplona (Juana Merino); H.U. Nuestra Señora de la Candelaria, Santa Cruz de Tenerife (Delia Almeida); H.U. Marqués de Valdecilla, Santander (Juan Irure); H.U. Puerta del Mar, Cádiz (Carmen Rodríguez); H.U. 12 de Octubre, Madrid (Antonio Serrano); H. U. Puerta de Hierro, Majadahonda (Aresio Plaza, Isidro Jarque); H.U. Virgen del Rocío, Sevilla (Marco A. Montes); H.U. Valle Hebrón, Barcelona (Maite Sanz, Laura Viñas); H.U. Central de Asturias, Oviedo (Lourdes Mozo); H.U. Ramon y Cajal, Madrid (Ángela Carrasco); H.U. de Bellvitge, L’Hospitalet de Llobregat (Fran Morandeira); H.U. Juan Ramón Jiménez, Huelva (Beatriz Rodríguez, Irene Magriz); CLILAB Diagnostics, Vilafranca del Penedès (Clara Esteve); H. Cínico Universitario de Valencia, Valencia (Jaime Pérez); H.U. de Jaén, Jaén (Esther Ocaña); H.U. Virgen de la Arrixaca, Murcia (Pedro Martínez); H.U. Reina Sofía, Córdoba (Sara Cantisán, Rocío Aguado, Aurora Jurado); Complejo asistencial universitario de León, León (Sara Calleja).

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Authors and Affiliations

  1. Immunology Department, Hospital de La Santa Creu I Sant Pau, Universitat Autònoma de Barcelona, Sant Pau Biomedical Research Institute (IIB Sant Pau), Barcelona, Spain

    Laura Martínez-Martínez, Anna Calvet Lacruz, Yolanda Álvaro, Elisabeth Moltó, Esther Ortiz, Cándido Juárez & Anaís Mariscal

  2. Neurology Department, Neuromuscular Diseases Unit, Hospital de La Santa Creu I Sant Pau, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain

    Luis Querol, Elena Cortés-Vicente, Elba Pascual, Ricard Rojas-García, David Reyes-Leiva & Eduard Gallardo

  3. Neuromuscular Diseases Unit, Centre for Networked Biomedical Research in Rare Diseases (CIBERER), Instituto de Salud Carlos III, Madrid, Spain

    Luis Querol, Elena Cortés-Vicente, Elba Pascual, Ricard Rojas-García & Eduard Gallardo

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  1. Laura Martínez-Martínez
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Consortia

The 2022 GEAI-S. E. I. Workshop participants

Contributions

LMM and AM contributed to conceptualization, supervision, validation, and visualization; LMM, ACL, and AM performed data curation and formal analysis; LMM, LQ, ECV, EP, RRG, DRL, YA, EM, EO, EG, CJ, and AM were involved in investigation and writing—review and editing; CJ provided resources; LMM, ACL, CJ, and AM were involved in roles/writing—original draft.

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Correspondence to Anaís Mariscal.

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The participating laboratories of “The 2022 GEAI-SEI Workshop participants” are listed in the acknowledgements.

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Martínez-Martínez, L., Lacruz, A.C., Querol, L. et al. Inter-laboratory comparison of routine autoantibody detection methods for autoimmune neuropathies and myasthenia gravis. J Neurol (2024). https://doi.org/10.1007/s00415-024-12317-0

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