Comprehensive assessment and standardization of solid phase multiplex-bead arrays for the detection of antibodies to HLA.

摘要: Solid phase multiplex-bead arrays for the detection and characterization of HLA antibodies provide increased sensitivity specificity compared to conventional lymphocyte-based assays. Assay variability due inconsistencies in commercial kits differences standard operating procedures (SOP) hamper comparison results between laboratories. The Clinical Trials Organ Transplantation Antibody Core Laboratories investigated sources assay variation determined if reproducibility improved through utilization SOP, common reagents normalization algorithms. Ten from two manufacturers were assessed each seven laboratories using 20 reference sera. Implementation a standardized (vs. nonstandardized) procedure greatly reduced MFI 62% 25%. Although laboratory agreements exceeded 90% (R2), small systematic observed suggesting center specific factors still contribute variation. varied according manufacturer, kit, bead type lot. ROC analyses showed excellent consistency antibody assignments (AUC > 0.9) suggested optimal cutoffs 1000 1500 MFI. Global further levels near 20%. Standardization solid tests will enable data across clinical trials diagnostic testing.