间接酶联免疫吸附试验检测免疫人群血清狂犬病病毒抗体的效能评价  

Efficacy evaluation of indirect enzyme-linked immunosorbent assay in detecting serum rabies virus antibodies in population immunized with rabies vaccines

作　　者：罗静霞[1] 韦利玲 卢海金 梁桂荣 梁伟献[1] 张丽芳[1] 梁江明[1] LUO Jing-xia;WEI Li-ling;LU Hai-jin;LIANG Gui-rong;LIANG Wei-xian;ZHANG Li-fang;LIANG Jiang-ming(Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control,Nanning,Guangxi 530021,China)

机构地区：[1]广西壮族自治区疾病预防控制中心,广西南宁530021

出　　处：《实用预防医学》2022年第3期295-298,共4页Practical Preventive Medicine

基　　金：广西卫计委计划课题(Z2015454)。

摘　　要：目的用金标准快速荧光灶抑制试验(rapid fluorescent focus inhibtion test, RFFIT)评价间接ELISA检测免疫人群血清狂犬病病毒抗体的效能。方法收集在广西壮族自治区疾病预防控制中心门诊部首次全程接种狂犬病疫苗的个体血清和加强免疫血清共314份,用RFFIT和间接ELISA两种方法对其进行狂犬病病毒抗体检测。结果 314份血清标本用两种方法检测结果一致率为81.85%,与RFFIT比较,间接ELISA检出阳性结果符合率为83.50%,阳性预计值为96.88%,阴性符合率为52.94%,阴性预计值为15.52%,经McNemar检验两种方法检出结果差异有统计学意义(P<0.05);进一步从RFFIT值分析得出87.76%的假阴性标本都存在于RFFIT值<3.0 IU/ml的标本中,从免疫后时间分析得出93.88%的假阴性标本都存在于免后1~3年标本中,而对于高RFFIT值的血清标本特别是全程免疫后42 d和加强免疫的高几何平均滴度的血清标本,间接ELISA结果假阴性率很低(3.26%及以下),两种方法检测结果一致率高达95.70%及以上,经McNemar检验两种方法检出结果差异无统计学意义(P>0.05)。结论间接ELISA可以用在狂犬病疫苗全程免疫后抗体阳转率的普查,用于个人免疫效果的评价方面需谨慎。Objective To evaluate the effectiveness of indirect enzyme-linked immunosorbent assay(ELISA) in detecting serum rabies virus antibodies of immunized population with the gold standard called rapid fluorescent focus inhibition test(RFFIT). Methods A total of 314 serum samples were collected after the subjects receiving full course immunization and booster doses of rabies vaccines for the first time in the outpatient department of Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control. RFFIT and indirect ELISA were used to detect antibodies against rabies virus. Results The agreement rate of results in the 314 serum samples detected by the two methods was 81.85%. Compared with RFFIT, the positive coincidence rate of indirect ELISA was 83.50%, the positive expected value 96.88%, the negative coincidence rate 52.94%, and the negative expected value 15.52%. There were statistically significant differences in the detection results of the two methods by McNemar test(P<0.05). It showed that 87.76% of false-negative specimens were present in specimens with RFFIT value <3.0 IU/ml by further analysis, and 93.88% of false-negative specimens present in specimens collected at 1-3 years after the immunization. As for serum specimens with high RFFIT values, especially serum specimens with a high geometric mean titer(GMT) at day 42 after the full course of immunization and the booster, the false-negative rate was very low(3.26% and below) by indirect ELISA. The result agreement rate of the two methods was up to 95.70% and above. The differences in the detection results of the two methods were not statistically significant(P>0.05)by McNemar test. Conclusion Indirect ELISA can be used for the general survey of antibody positive conversion rate after the full course of rabies vaccination. But it should be cautiously used in the evaluation of individual immune effect.

关 键 词：快速荧光灶抑制试验 酶联免疫吸附试验 狂犬病病毒抗体 

分 类 号：R446.6[医药卫生—诊断学]