直接化学发光免疫分析法作为传染四项快速检测方法的应用探讨

Application of Direct Chemiluminescence Immunoassay to Rapid Detection of Infectious Agents Before Endoscopy

目的评价直接化学发光免疫分析法（chemiluminescence immunoassay,CLIA）作为消化性内镜前传染性指标：乙型肝炎表面抗原（HBsAg）、丙型肝炎抗体（抗-HCV）、梅毒螺旋体抗体（抗-TP）和人类免疫缺陷病毒抗体（抗HIV-1/2）四个项目快速检测方法的价值。方法对本院2015年4月13日~4月20日共561例急诊筛查传染性指标四项的住院门诊患者,同时用免疫层析法和直接化学发光免疫分析法平行检测乙型肝炎表面抗原（HBsAg）、丙型肝炎抗体（抗-HCV）、梅毒螺旋体抗体（抗-TP）和人类免疫缺陷病毒抗体（抗HIV-1/2）,对上述两种方法检测出的阳性结果用ELISA方法复检,比较两种方法的检测结果。结果 561例标本免疫层析法检测阳性标本数HBsAg11例（1.96%）,抗-HCV11例（1.96%）,抗-TP19例（3.39%）,抗-HIV-1/2 5例（0.89%）,直接化学发光免疫分析法检测阳性标本数HBsAg11例（1.96%）,抗-HCV4例（0.71%）,抗-TP8例（1.43%）,抗-HIV-1/2 3（0.53%）例。两种方法阳性标本经ELISA方法复检后阳性标本例数分别为：免疫层析法HBsAg11例（100%）,抗-HCV2例（18.18%）,抗-TP8例（42.11%）,抗-HIV-1/2 0例（0）,直接化学发光免疫分析法HBsAg11例（100%）,抗-HCV2例（50%）,抗-TP6例（100%）,抗-HIV-1/2 0例（0）。结论在临床快速筛查HBsAg、抗-HCV、抗-TP、抗-HIV-1/2时,直接化学发光免疫分法较免疫层析法复检率低,复检后阳性率高,相对更为经济、高效、准确。

Objective To assess the value of rapid screening of four infectious agents of HBsAg, Anti-HCV, AntiTP, and Ant-HIV1/2 by direct chemiluminescence immunoassay before gastrointestinal endoscopy. Methods 561 inpatients and outpatients from April 13 th, 2015 to April 20 th, 2015 were selected All cases were subjected to rapid detection for four infectious indicators by Immune chromatography and direct chemiluminescence immunoassay at the same time. Positive results from these two methods were retested by ELISA for comparison of the two methods.Results Among the 5 6 1 cases, 11（1.96%） were HBsAg positive 11（1.96%）, 11（1.96%）were anti–HCV positive, 19（3.39%）were anti TP positive, and 5（0.89%）were anti HIV-1/2 positive when tested by immune chromatography. Positive cases of direct chemiluminescence immunoassay included 11（1.96%）of HBsAg, 4（0.71%）of anti-HCV, 8（1.43%）of anti-TP, and 3（0.53%）of anti HIV-1/2. Positive cases tested by both two method were redetected with ELISA, and the results showed were：11（100%）of HBsAg, 2（18.18%）of anti-HCV, 8（42.11%）of anti-TP, and 0（0%）of anti HIV-1/2 in immunochromatography positive samples. The positive cases of direct chemiluminescence immunoassay that were redetected by ELISA presented 11（100%）of HBsAg, 2（50%）of anti-HCV, 8（100%） of anti-TP, and 0（0%）of anti- HIV-1 /2. Conclusion Compared to immune chromatography, direct chemiluminescence immunoassay, which is more economical, efficient and accurate, has a high positive rate in retest of HBsAg, anti-HCV, anti-TP and anti-HIV1/2 for clinical serum screening.