Imunoquímica e Imunopatologia

Performance Characteristics of a Novel, Fully Automated Planar Microarray Immunoassay for the Detection of Antibodies against Centromere Protein B

Abstract

Pascale Ghillani-Dalbin, Christel Daubrosse, Valrie Mercier, Rocio Pasion-Galvan, Gerber Gomez, Daphne Bijlsma, Ewa Lukasik, Valeria Botti, Emmanuel Moreau, Christine C. Ginocchio, Michael Hausmann and Makoto Miyara

Introduction: Autoantibody testing, including against Centromere Proteins (CENP), is important in the identification of autoimmune diseases. Test methods may be manual, slow, labor-intensive and/or fragmented. Development of highly automated tools is needed. We aimed to evaluate the performance of MosaiQ® CENP-B (CENP-B-MA), a planar microarray immunoassay designed for use with the fully automated, continuous random access, high-throughput MosaiQ System, for the qualitative serological detection of anti-CENP-B autoantibodies (ACA-B) as an aid in the diagnosis of systemic sclerosis.

Methods: A comparator study was performed at Hôpital Pitié-Salpêtrière, Paris, France using anonymized serum samples, characterized as ACA-B non-reactive or reactive with CE-marked devices. Reproducibility and repeatability evaluations were also performed.

Results: After resolver testing, CENP-B-MA identified 96/99 samples characterized as reactive and all 199 non-reactive samples: positive percent agreement: 97% (95% CI, 91.4%, 99.4%), negative percent agreement: 100% (95% CI, 98.2%, 100%), overall percent agreement: 99% (95% CI, 97.1%, 99.8%). Reproducibility and repeatability evaluation showed, respectively, overall agreement of 99.7% (95% CI, 99.4%, 99.9%) and 100%.

Conclusion: Performance of CENP-B-MA shows high concordance with other CE-marked assays for detecting ACA-B, with a high degree of reproducibility and repeatability.