一般人群乙型肝炎调查、试剂评价及混合血清法检测的初步探讨

发布时间：2019-06-12 00:02

【摘要】： 目的:(1)调查江苏省一般人群乙肝的感染情况。(2)研究并比较常用国产乙型肝炎表面抗原诊断试剂盒以及国外相应试剂盒的检测性能,并对各个试剂盒的cutoff值进行评价。(3)建立二维混合血清法检测病毒核酸的数学模型,并讨论不同阳性率时最优混合样本数和对应节约的检测次数。研究方法:(1)按照多级抽样抽取金坛市、海门市、海安县、赣榆县的一般人群,开展一般人群乙肝血清学指标检测。(2)采用SAS8.0软件,对乙肝的各项检测指标进行比较,并对乙肝各指标的影响因素进行Logistic回归分析。(3)使用国产和国外乙型肝炎表面抗原诊断试剂盒对已知HBsAg阴性和阳性血清、国家参考品进行检测,比较各试剂盒的检测性能。(4)根据检测样本的OD值,绘制各试剂盒的ROC曲线。根据ROC曲线获得最优cutoff值,计算相应试剂盒的灵敏度和特异度,并与试剂盒提供的cutoff值得到的灵敏度、特异度进行比较。研究结果:(1)江苏省一般人群的HBsAg总阳性率为4.84%,大年龄组的HBsAg阳性的概率高于小年龄组,苏中和苏南地区的HBsAg阳性的概率高于苏北地区。女性HBsAg阳性的概率低于男性。HBsAb总阳性率为50.34%,20岁以上各年龄组的阳性概率低于1-5岁组。男性和女性HBsAb阳性的概率未见差异。苏中HBsAb阳性的概率低于苏北,而苏南HBsAb阳性的概率高于苏北。HBcAb总阳性率为49.83%,年龄越大,HBcAb阳性的概率越大,女性HBcAb阳性的概率高于男性。20岁以上各组HBcAb阳性的概率均高于1-5岁组。与苏北相比,苏中和苏南HBcAb阳性的概率较高。(2)以已知的HBsAg阴性、阳性的血清和国家参考品为标准,意大利索林乙型肝炎表面抗原诊断试剂盒灵敏度高于其他试剂盒。以已知的HBsAg阴性、阳性的血清和国家参考品为标准,不包括中国药品生物制品检定所(NICPBP)的灵敏度参考品,各试剂盒的灵敏度未见差异。单独以国家参考品为标准,不包括NICPBP灵敏度参考品,各试剂盒的灵敏度也未见差异。(3)以NICPBP的灵敏度参考品和卫生部临床检验中心(NCCL)低值阳性参考品为标准,国产四种乙型肝炎表面抗原诊断试剂盒之间的灵敏度未见差异;而意大利索林对低值阳性参考品检测的灵敏度高于所有的国产试剂盒。(4)以NICPBP和NCCL参考品为标准,乙型肝炎表面抗原国产诊断试剂盒由最优cutoff值得到的灵敏度高于说明书给的cutoff值得到的灵敏度,意大利索林的灵敏度前后相同。各试剂盒不同标准下特异度均未见差异。(5)二维混合血清法数学模型表明混合血清法可以减少检测次数,节约筛检费用。
[Abstract]:Objective: (1) to investigate the infection of hepatitis B in Jiangsu province. (2) to study and compare the detection performance of domestic hepatitis B surface antigen diagnostic kit and the corresponding foreign kit, and to evaluate the cutoff value of each kit. (3) to establish a mathematical model for the detection of viral nucleic acid by two-dimensional mixed serum method, and to discuss the optimal number of mixed samples and the corresponding saved detection times. Methods: (1) according to the multi-stage sampling, the general population of Jintan City, Haimen City, Haian County and Ganyu County were selected to detect the serological indexes of hepatitis B. (2) the detection indexes of hepatitis B were compared by SAS8.0 software. The influencing factors of hepatitis B indexes were analyzed by Logistic regression analysis. (3) the known HBsAg negative and positive serum and national reference materials were detected by domestic and foreign hepatitis B surface antigen diagnostic kits, and the detection performance of each kit was compared. (4) according to the OD value of the test samples, the ROC curves of each kit were drawn. According to the ROC curve, the optimal cutoff value was obtained, and the sensitivity and specificity of the corresponding kit were calculated, and compared with the sensitivity and specificity obtained by the cutoff value provided by the kit. The results were as follows: (1) the total positive rate of HBsAg in Jiangsu province was 4.84%. The probability of HBsAg positive in older group was higher than that in younger age group, and the probability of HBsAg positive in central and southern Jiangsu was higher than that in northern Jiangsu. The positive probability of HBsAg in women was lower than that in males. The total positive rate of HBsAg was 50.34%. The positive probability of HBsAg in all age groups over 20 years old was lower than that in 1 < 5 years old group. There was no difference in the probability of HBsAb positive between men and women. The probability of HBsAb positive in Jiangsu was lower than that in northern Jiangsu, while the positive probability of HBsAb in southern Jiangsu was 49.83%. The older the age, the greater the probability of HBcAb positive, and the positive probability of HBcAb in women was higher than that in males. The probability of HBcAb positive in each group over 20 years old was higher than that in the group aged 1 to 5 years old. Compared with northern Jiangsu, the probability of HBcAb positive in central and southern Jiangsu is higher. (2) based on the known HBsAg negative, positive serum and national reference materials, the sensitivity of Italian Solin hepatitis B surface antigen diagnostic kit is higher than that of other kits. According to the known HBsAg negative, positive serum and national reference materials, excluding the sensitivity reference materials of (NICPBP) in China Institute of Pharmaceutical and Biological products, there was no difference in the sensitivity of each kit. The sensitivity of each kit was not different according to the national reference material and excluding the NICPBP sensitivity reference material. (3) there was no difference in the sensitivity of the four domestic hepatitis B surface antigen diagnostic kits based on the sensitivity reference of NICPBP and the (NCCL) low value positive reference of the clinical examination center of the Ministry of Health. The sensitivity of Italian Solin to low value positive reference was higher than that of all domestic kits. (4) according to NICPBP and NCCL reference materials, the sensitivity of hepatitis B surface antigen domestic diagnostic kit was higher than that of cutoff value given in specification, and the sensitivity of Italian Solin was the same before and after. There was no difference in the specificity of each kit under different standards. (5) the mathematical model of two-dimensional mixed serum method showed that the mixed serum method could reduce the detection times and save the screening cost.
【学位授予单位】：东南大学
【学位级别】：硕士
【学位授予年份】：2006
【分类号】：R181.3

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