摘要
Abstract
Objective To evaluate the susceptibility of alanine aminotransferase(ALT)and enzyme-linked immunosorbent assay(ELISA)employed in blood screening laboratories for hemolysis and lipemia samples,and to establish assay-specific interference thresholds for these variables.Methods Hemolysis samples with gradient hemoglobin(Hb)concentrations(0,1,2,4,5,7.5 and 10 g/L)and lipemia samples with gradient triglyceride(TG)concentrations(0,0.63,1.27,2.54,5.08 and 10.15 mmol/L)were prepared.Interference effects were evaluated using three methods:gradient dilution linear regression,pre-and post-centrifugation bias analysis for ALT,(an absolute bias of≤7.5%considered acceptable),and reactivity consistency testing for ELISA(maintaining an original reactivity/non-reactivity status).Based on these results,visual color charts for hemolysis and lipemia were developed.Results ALT demonstrated acceptable performance up to the highest tested triglyceride(TG)level(10.15 mmol/L),as evidenced by a linear regression slope of b=1,intercept a≈0,and absolute bias≤7.5%.ALT was also robust against hemolysis up to Hb=4 g/L(absolute bias≤7.5%).Among ELISA items,anti-HCV(sandwich method)and P24 antigen detected by HIV Ag/Ab reagent(4th generation)showed false negatives when TG=5.08 mmol/L.3rd-generation and 4th-generation HIV Ag/Ab antibodies testing showed false negatives when Hb 4 g/L,while HBsAg testing showed false positives when Hb≥5 g/L.Considering these results of all items,the maximum acceptable interference thresholds were established as Hb 2 g/L and TG 2.54 mmol/L.Conclusion Hemolysis and lipemia significantly interfere with blood screening assay.Establishing unified,clinically relevant interference thresholds is essential to ensure result reliability and transfusion safety.关键词
溶血/脂血/血液筛查/检测阈值Key words
Hemolysis/Lipemia/Blood screening/Detection threshold分类
医药卫生
