Lot-to-lot variability in HLA antibody screening using a multiplexed bead-based assay

摘要: Background Identifying antibodies to HLA (anti-HLA) by solid-phase assays is used screen blood donors mitigate transfusion-related acute lung injury risk. Various cutoffs for detection have been proposed in the literature; however, these do not take into consideration lot-to-lot variability of commercially available assays. Study Design and Methods Samples from 93 nontransfused males were tested using five different lots a multiplex bead-based anti-HLA kit. A subset 17 samples was on 5 days single lot. An additional 96 donations with varied levels kits two lots. Results reported as normalized background (NBG) ratio. Results For donors, NBG values generated reference lot significantly higher than those obtained three four comparator However, low-, moderate-, higher-level anti-HLA, Class I (CL-I) 1.4 times lower Class II (CL-II) 1.2 versus For CL-I between-lot standard deviation (SD) 1.36 (95% confidence interval [CI], 1.19-1.60), while between-day SD 1.27 CI, 1.08-1.52). Similarly, CL-II 0.81 0.70-0.95), 0.50 0.43-0.60). Conclusions There interlot assay well significant bias between It may be reasonable develop new cutoff when obtained.