This article reviews the current evidence to classify donor-specific antibodies (DSAs) using Food and Drug Administration-National Institutes of Health Biomarkers, EndpointS, and other Tools (BEST) resource terms as diagnostic, prognostic, predictive, monitoring, and risk biomarkers for graft rejection. The emphasis is on DSA characteristics, including the DSA levels determined by mean fluorescence intensity and/or titers, the ability to activate a complement cascade (C1q, C3d, and C4d binding), and specific IgG subclasses to define distinct roles of DSAs as biomarkers in clinical practice. In addition, technical limitation of DSA testing is discussed.
Keywords: Biomarker; C1q; Donor-specific antibody; IgG subclass; Rejection; Titer.
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