化学发光微粒子免疫分析法复查输血前感染性指标的回顾性分析

Retrospective analysis on reexamination of infective markers of pretransfusion testing by chemiluminescent microparticle immunoassay

目的:评估化学发光微粒子免疫分析法(CMIA)对输血前感染性指标检测结果的重复性,并制定合理的复查策略。方法:对2010-05-2011-11送检标本中低浓度HBsAg或属于乙肝少见指标组合模式的HBsAg436例、HBsAb 194例、HBeAg 147例、HBeAb 161例、HBcAb 85例,以及756例HCV阳性、707例Syphilis阳性和94例HIV初筛阳性的标本进行复查,评估两者之间的重复性。结果:HBsAg复查前后符合率为63.07%,HBsAg在浓度≤0.1U/mL、0.1～1.0U/mL、1～10U/mL和>10U/mL的符合率分别为38.25%、66.07%、84.21%、96.11%,各组均差异有统计学意义(P<0.01)。进一步分组后在0.05～0.15U/mL与0.15～1.00U/mL两组中复查前后符合率在统计学上有差异(均P<0.05);HBsAb、HBeAg、HBeAb、HBcAb、HCV、Syphilis和HIV复查前后符合率分别为96.39%、91.16%、96.27%、96.47%、97.35%、98.73%、91.49%。HCV在S/CO值为0.90～1.09与1.10～1.59,两组复查前后符合率差异有统计学意义(P<0.01)。结论:CMIA检测HBsAb、HBeAg、HBeAb、HBcAb、HCV、Syphilis和HIV重复性好,但HBsAg重复性较差。当HCV S/CO值在0.90～1.09以及HBsAg浓度≤0.15U/mL时,必须通过高速离心复查以确保检测结果的真实性。

Objective：To assess the reproducibility of detecting infective markers of pretransfusion testing by chemiluminescent microparticle immunoassay（CMIA）,and develop a reasonable strategy of reexamination. Method：Blood samples were reexamined due to low concentration of HBsAg or rare models in combination of HBV markers from May 2010 to Nov 2011 in our hospital by CMIA including 436 cases of HBsAg,194 cases of HBsAb,147 cases of HBeAg,161 cases of HBeAb,85 cases of HBcAb,756 cases of HCV,707 cases of Syphilis and 94 cases of HIV,and their concordance were assessed. Result：The coincident rate in marker of HBsAg was 63.07%.The coincident rates of HBsAg whose concentration≤0.1 U/mL,0.1-1.0 U/mL,1-10 U/mL and 10 U/mL were 38.25%,66.07%,84.21% and 96.11%,respectively,and the significant differences were found in all the above groups（P0.01）.By further grouping,the coincident rates of HBsAg whose concentration between 0.05-0.15 U/mL and 0.15-1.00 U/mL had significant differences from statistics（P0.05）.The coincident rates of HBsAb,HBeAg,HBeAb,HBcAb,HCV,Syphilis and HIV were 96.39%,91.16%,96.27%,96.47%,97.35%,98.73% and 91.49%,respectively.The coincident rates of HCV whose values of S/CO between 0.90-1.09 and 1.10-1.59 had significant differences（P0.01）. Conclusion：The reproducibilities were good in detection of HBsAb,HBeAg,HBeAb,HBcAb,HCV,Syphilis and HIV by CMIA,rather than in the detection of HBsAg.When HCV whose values of S/CO were 0.90-1.09,or HBsAg whose concentration less than 0.15 U/mL,the reexaminations should be performed with high speed centrifugation to ensure the accuracy.