Serum GFAP в качестве биомаркера для продвижения в множестве склероза: сравнение с оценками и большая справочная база данных о здоровом контроле.
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Willemse Eline A J, Sandgren Sofia, Benkert Pascal, Schaedelin Sabine, Maceski Aleksandra Maleska, Oechtering Johanna, Genc Nafiye, Berger Klaus, Hermesdorf Marco, Müller Stefanie, Finkener Sebastian, Vilchez Gomez Juan F, Zadic Amar, Disanto Giulio, D'Souza Marcus, Granziera Cristina, Pot Caroline, Zecca Chiara, Lalive Patrice H, Hoepner Robert, Roth Patrick, Herwerth Marina, Gobbi Claudio, Leppert David, Einsiedler Maximilian, Kuhle Jens
Аннотация
Оригинал публикации
Serum GFAP as a biomarker for progression in multiple sclerosis: assay comparison and a large reference database of healthy controls.
OBJECTIVES: Compare Elecsys (Roche) and Simoa (Quanterix) immunoassays for serum glial fibrillary acidic protein (GFAP) using our reference database and Z scores, and evaluate their prognostic value for progression independent of relapse activity (PIRA) in multiple sclerosis (MS).
METHODS: Platform correlation was assessed in 612 samples from healthy controls (n=188; median [interquartile range, IQR] age 45.1 [36.4-61.7] years) and people with MS (n=424; 45.3 [35.2-53.9] years). Elecsys values were converted to Z scores via Passing-Bablok-derived regression and validated in fingolimod (n=414), and B-cell depleting therapy (BCDT; n=353) cohorts. Z scores and hazard ratios (HRs) for time-to-PIRA were compared using Cox regression.
RESULTS: GFAPSimoa and GFAPElecsys measurements were correlated (r=0.94), with Elecsys values ∼54 % lower (GFAPElecsys, ng/L=2.847 [95 % confidence interval, CI: 1.335 - 4.98] + 0.457 [0.434 - 0.478] * GFAPSimoa, ng/L). In univariable Cox models, GFAPSimoa and GFAPElecsys Z scores were associated with time-to-PIRA in both validation cohorts. In multivariable Cox models, higher GFAPSimoa Z scores were associated with shorter time-to-PIRA in fingolimod cohort (HR: 1.27 [95 % CI 1.08 - 1.50], p=0.0031) and trended toward significance in BCDT (1.18 [0.99 - 1.41, p=0.0693). In contrast, GFAPElecsys Z scores were associated with time-to-PIRA in both cohorts (fingolimod: 1.27 [1.09 - 1.48], p=0.0023; BCDT: (1.19 [1.00 - 1.40], p=0.0487).
CONCLUSIONS: Serum GFAP measured by Elecsys shows a comparable association with time-to-PIRA as Simoa, and GFAPSimoa Z scores can be successfully bridged to GFAPElecsys Z scores, supporting Elecsys`s potential for clinical implementation.