增强化学发光法检测手术及输血感染标志物的临床应用

The clinical application of enhanced chemiluminescence on detecting operation and blood transfusion infection marks

目的对增强化学发光法检测感染性标志物进行临床应用评价。方法采用美国强生增强化学发光技术检测系统及配套试剂对乙肝表面抗原(HBsAg)、抗丙型肝炎病毒抗体(抗-HCV)、抗人类免疫缺陷病毒抗体(抗-HIV)、抗梅毒螺旋体特异性抗体(抗-TP)进行初筛检测,阳性标本立即重新复查一次,仍为阳性者判断为初筛试验阳性。对于HBsAg、抗-HCV初筛阳性标本采用酶联免疫吸附试验(ELISA法)进行确证;抗-HIV初筛阳性者送HIV确诊实验室进行确诊、抗-TP初筛阳性者采用梅毒螺旋体明胶颗粒凝集试验(TPPA)进行确证。结果增强化学发光法检测HBsAg、抗-HCV、抗-HIV、抗-TP的阳性检出率分别是5.83%、0.75%、0.05%、2.73%,阳性检出率均高于各检测项目的复检确认方法的阳性率。41123例术前检查患者血清标本中,应用增强化学发光法共筛查出2399例HBsAg阳性标本、308例抗-HCV阳性标本、19例抗-HIV阳性标本、1123例抗-TP阳性标本。筛查的阳性标本经各项目的复检确认方法进行复检确认后,共确认出2325例HBsAg阳性标本、299例抗-HCV阳性标本、17例抗-HIV为阳性标本、1054例抗-TP阳性标本。应用增强化学发光法检测HBsAg、抗-HCV、抗-HIV、抗-TP的S/CO值分别在5.71、9.24、15.9、10.82以上时,经复检后各检测项目均呈现100%的阳性。结论增强化学发光法HBsAg、抗-HCV、抗-HIV、抗-TP的检测特异性大于99%,检测阳性预测值完全能够满足临床诊疗需求,检测过程和工作效率都优于常规免疫标记技术,值得临床推广应用。

Objective Clinical application evaluation of enhanced chemiluminescence on detecting operation and blood transfusion infection marks.Methods A preliminary screening was carried out on the results of operation and blood transfusion infection marks,including HBsAg,anti-HCV,anti-HIV and anti-TP,by using JNJ enhanced chemiluminescence.We confirmed the positive results of preliminary screening if the results of twice repeated test were all positive.In order to make a definite diagnosis,ELISA was carried out on preliminary screening positive samples of HBsAg and anti-HCV test.The positive samples of HIV were sent to AIDS confirmed lab of CDC.TPPA was carried out on positive samples of anti-TP test.Results The positive detection rate of HBsAg,anti-HCV,anti-HIV and anti-TP were5.83%,0.75%,0.05%,and 2.73% by using enhanced chemiluminescence.The positive detection rate was all higher than the re-inspection confirmed methods.Among 41123 cases of patients＇ serum specimens,2399 cases were HBsAg positive specimens,308 cases were anti-HCV positive specimens,19 cases were anti-HIV positive specimens and 1123 cases were anti-TP positive specimens by using enhanced chemiluminescence.Those positive specimens were confirmed by re-inspection confirmed methods.The result showed that 2325 cases were HBsAg positive specimens,299 cases were anti-HCV positive specimens,17 cases were anti-HIV positive specimens and 1054 cases were anti-TP positive specimens.When the S/CO values of HBsAg,anti-HCV,anti-HIV and anti-TP were higher than 5.71,9.24,15.9and10.82 by using enhanced chemiluminescence detection,those specimens were all 100% positive with re-inspection confirmed.Conclusion Enhanced chemiluminescence applied on HBsAg,anti-HCV,anti-HIV,anti-TP detection worthy of clinical popularization and application,because the specificity of this method is greater than 99%.Positive predictive value of the method totally can satisfied the demand of clinical diagnosis and treatment.The detection process and efficiency of the method are all superior to conventional immunolabelling technique.