摘要目的：评价高敏发光底物结合脱磁清洗技术及滤镜转换技术的免疫分析仪定量检测乙型肝炎病毒表面抗原的临床性能。方法实验性能验证。验证该检测技术定量检测HBsAg的基本性能，包括重复性、功能灵敏度、线性、准确性，以及HBsAg血清转换检测的敏感性。从2014年10至12月四川大学华西医院的临床常规标本中纳入1007例阴性标本和82例潜在干扰标本，对其特异性进行评估，同时进行阴性“灰区”标本比率的分析；采用高敏化学发光酶免疫法（ HISCL ）和电化学发光免疫法（ ECLIA）两种方法检测HBsAg 0.03～2500 IU／ml范围内的阳性标本259例及弱阳性标本27例进行相关性分析。采用线性回归方程、Spearman 检验、Bland-Altman 分析进行统计分析。结果 HISCL定量分析两个浓度的日间精密度（ CV值）分别为1.55％和2.02％，日内精密度（ CV值）分别为0.34％和1.34％；功能灵敏度达0.007 IU／ml；在0～2300 IU／ml范围内线性良好（低浓度：y＝3.262x＋0.082，r＝0.994；高浓度：y＝2303.608x－33.006，r＝0.999）。 HISCL HBsAg检测系统能准确判断CAP质控品的结果，符合率为100％。 HISCL在检测HBsAg血清转换时呈高敏感性。其分析特异性达99.91％；“灰区”样本比率为1.66％。 HISCL和Elecsys HBsAg定量检测方法的相关性为r＝0.995，一致性为LOA：－0.3～0.19 log10 IU／ml。结论 HISCL HBsAg检测系统具有HBsAg定性和定量检测的性能、阴性“灰区”样本比率较低，能满足临床检测线性范围宽和快速检测的要求。（中华检验医学杂志，2015，38：537-542）

abstractsObjective To assess the clinic application of a new-style automated immunoassay system HISCL ( high sensitivity chemiluminescent enzyme immunoassay ) with high sensitive chemiluminescence substrate CDP-Star?, bind-free separate technology and filter conversion technology.Methods The performance verification test evaluated HISCL′s specification including reproducibility, functional sensitivity, linearity, accuracy, and sensitivity for HBsAg seroconversion.To evaluate the specificity , 1 007 HBsAg-negative specimens , 82 potentially interfering specimens were from conventional specimens in West China Hospital , Sichuan University between October and December of 2014.At the same time, with these results to determine the rate of the specimens that their results are in negative grey zone.259 HBsAg-positive specimens and 27 weakly-positive specimens were tested for the comparison between the HISCL and ECLIA ( electrochemiluminescence immunoassay ) HBsAg quantification.A linear regression model , Pearson′s correlation and Bland-Altman analysis were used as statistical methods.Results The between day and within-lot variable coefficient of two level samples are 1.55%, 2.02%, 0.34%, 1.34%separately.The functional sensitivity of the HISCL HBsAg assay reaches 0.007 IU /ml.There is a good linearity (y=3.262x+0.082,r=0.994; y=2 303.608x-33.006,r=0.999) within range of 0-2 300 IU/ml.HISCL obtain the accurate results for the CAP control material , the agreement rate is 100%.The sensitivity for the detection of HBsAg seroconversion is high.The specificity is 99.91%.The negative grey zone rate is 1.66%.The results of these two methods have good correlation and uniformity , r=0.995, LOA:-0.3 -0.19 log10 IU/ml.Conclusions HISCL HBsAg detection system shows good detection performance.Be of the function of both qualitative and quantitative detection.And the negative “grey zone”specimen rate is low.It is wholly capable of wide linearity and quick assays for quantifying serum HBsAg levels.HISCL could contribute to improve HBsAg quantitative detection process for clinical laboratory.