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
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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。
Objective: (1) To investigate the infection of the Hepatitis B Virus (HBV) in the general people of Jangsu Province. (2) To research and compare the test capability between the widely used HBsAg diagnosis kits made in our country and which of the kit made overseas, and evaluate the cutoff value of these kits. (3) To establish the two-dimensional mathematics model of testing virus nucleic acid in mini-pool, and to discuss the best pool number when the positive rate is different, and the corresponding saved test times.
Methods: (1) According to the multilevel sampling, sample the general people of Jintan, Haimen, Haian and Ganyu, and examine the serological markers of the hepatitis B virus of the sample. (2) To test the serological markers of HBV and to compare the positive rates of the markers, and analyze the effect factors with Logistic regression by SAS8.0 software. (3) To test the known HBsAg negative and positive serums and the national reference serums by the HBsAg diagnosis kits made in our country and overseas. And compare the test abilities of the kits. (4)Draw the ROC curves of all the kits based on the OD values of the samples tested. Compare the sensitivities and specificities determined by the cutoff values from the guidebooks of the kits and from the best cutoff values of the ROC curves.
Results : (1) The total positive rate of HBsAg of the general people of Jiangsu Province is 4.84%, and the probabilities of the positive rates of HBsAg of the older groups are higher than which of the younger groups. The probabilities of the positive rates of HBsAg of the middle area of Jiangsu and the south area of Jiangsu are higher than which of the north area of Jiangsu. The probability of the positive rate of HBsAg of the female is lower than which of the male. The total positive rate of HBsAb is 50.34%, the probabilities of the positive rates of HBsAb of the groups elder than twenty are lower than which of the 1-5 years old group. And there is no difference between the probabilities of the positive rates of HBsAb of the male and the female. The probability of the positive rate of HBsAb of the middle area of Jiangsu is lower than which of the north area of Jiangsu , and the probability of the positive rate of HBsAb of the south area of Jiangsu are higher than which of the north area of Jiangsu. The total positive rate of HBcAb is 49.83%, the probability
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。
Objective: (1) To investigate the infection of the Hepatitis B Virus (HBV) in the general people of Jangsu Province. (2) To research and compare the test capability between the widely used HBsAg diagnosis kits made in our country and which of the kit made overseas, and evaluate the cutoff value of these kits. (3) To establish the two-dimensional mathematics model of testing virus nucleic acid in mini-pool, and to discuss the best pool number when the positive rate is different, and the corresponding saved test times.
Methods: (1) According to the multilevel sampling, sample the general people of Jintan, Haimen, Haian and Ganyu, and examine the serological markers of the hepatitis B virus of the sample. (2) To test the serological markers of HBV and to compare the positive rates of the markers, and analyze the effect factors with Logistic regression by SAS8.0 software. (3) To test the known HBsAg negative and positive serums and the national reference serums by the HBsAg diagnosis kits made in our country and overseas. And compare the test abilities of the kits. (4)Draw the ROC curves of all the kits based on the OD values of the samples tested. Compare the sensitivities and specificities determined by the cutoff values from the guidebooks of the kits and from the best cutoff values of the ROC curves.
Results : (1) The total positive rate of HBsAg of the general people of Jiangsu Province is 4.84%, and the probabilities of the positive rates of HBsAg of the older groups are higher than which of the younger groups. The probabilities of the positive rates of HBsAg of the middle area of Jiangsu and the south area of Jiangsu are higher than which of the north area of Jiangsu. The probability of the positive rate of HBsAg of the female is lower than which of the male. The total positive rate of HBsAb is 50.34%, the probabilities of the positive rates of HBsAb of the groups elder than twenty are lower than which of the 1-5 years old group. And there is no difference between the probabilities of the positive rates of HBsAb of the male and the female. The probability of the positive rate of HBsAb of the middle area of Jiangsu is lower than which of the north area of Jiangsu , and the probability of the positive rate of HBsAb of the south area of Jiangsu are higher than which of the north area of Jiangsu. The total positive rate of HBcAb is 49.83%, the probability
引文
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