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Article

Validation of the Particle-Based Multi-Analyte Technology for Detection of Anti-PhosphatidylSerine/Prothrombin Antibodies

1
Center of Research of Immunopathology and Rare Diseases-Coordinating Center of Piemonte and Valle d’Aosta Network for Rare Diseases, S. Giovanni Bosco Hospital, Department of Clinical and Biological Sciences, University of Turin, 10154 Turin, Italy
2
School of Specialization of Clinical Pathology, Department of Clinical and Biological Sciences, University of Turin, 10125 Turin, Italy
3
Inova Diagnostics, San Diego, CA 92131, USA
4
Nephrology and Dialysis, Department of Clinical and Biological Sciences, S. Giovanni Bosco Hospital, University of Turin, 10154 Turin, Italy
*
Author to whom correspondence should be addressed.
Biomedicines 2020, 8(12), 622; https://doi.org/10.3390/biomedicines8120622
Received: 10 November 2020 / Revised: 11 December 2020 / Accepted: 14 December 2020 / Published: 17 December 2020
Among “extra-criteria” antiphospholipid (aPL) antibodies, anti-phosphatidylserine/prothrombin (aPS/PT) antibodies, are considered a part of risk assessment strategies when investigating patients suspected of having antiphospholipid syndrome (APS). aPL detection is currently performed by solid-phase assays to identify anti-cardiolipin (aCL), anti-β2glycoprotein I (aβ2GPI) and aPS/PT antibodies, but new techniques are emerging. Among these, particle-based multi-analyte technology (PMAT), which allows the full automation and simultaneous digital detection of autoantibodies and proteins, including IgG, IgA and IgM isotypes of aCL, aβ2GPI and aPS/PT. The aim of this study was to investigate the agreement of aPS/PT testing between enzyme-linked immunosorbent assay (ELISA) and the PMAT platform. A total of 94 patients were enrolled in the study, including 71 patients with confirmed APS and 23 “aPL carriers”. aPS/PT IgG showed a moderate binomial agreement between ELISA and PMAT (k = 0.57, 95% CI 0.45–0.75), and aPS/PT IgM showed a moderate agreement (k = 0.60, 95% CI 0.45–0.75). Moreover, when considering the continuous agreement, both aPS/PT IgG and IgM showed a statistically significant correlation between ELISA and PMAT (Spearman’s correlation = 0.69, p < 0.001 and 0.72, p < 0.001, respectively). This study demonstrates that PMAT technology is a reliable method for aPS/PT IgG and IgM testing when compared to the available commercial ELISA kit. View Full-Text
Keywords: antiphospholipid antibodies; antiphospholipid syndrome; anti-phosphatidylserine/prothrombin antibodies antiphospholipid antibodies; antiphospholipid syndrome; anti-phosphatidylserine/prothrombin antibodies
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MDPI and ACS Style

Radin, M.; Cecchi, I.; Foddai, S.G.; Rubini, E.; Barinotti, A.; Ramirez, C.; Seaman, A.; Roccatello, D.; Mahler, M.; Sciascia, S. Validation of the Particle-Based Multi-Analyte Technology for Detection of Anti-PhosphatidylSerine/Prothrombin Antibodies. Biomedicines 2020, 8, 622. https://doi.org/10.3390/biomedicines8120622

AMA Style

Radin M, Cecchi I, Foddai SG, Rubini E, Barinotti A, Ramirez C, Seaman A, Roccatello D, Mahler M, Sciascia S. Validation of the Particle-Based Multi-Analyte Technology for Detection of Anti-PhosphatidylSerine/Prothrombin Antibodies. Biomedicines. 2020; 8(12):622. https://doi.org/10.3390/biomedicines8120622

Chicago/Turabian Style

Radin, Massimo, Irene Cecchi, Silvia G. Foddai, Elena Rubini, Alice Barinotti, Carlos Ramirez, Andrea Seaman, Dario Roccatello, Michael Mahler, and Savino Sciascia. 2020. "Validation of the Particle-Based Multi-Analyte Technology for Detection of Anti-PhosphatidylSerine/Prothrombin Antibodies" Biomedicines 8, no. 12: 622. https://doi.org/10.3390/biomedicines8120622

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