Efficacy evaluation of indirect enzyme-linked immunosorbent assayin detecting serum rabies virus antibodies in population immunized with rabies vaccines
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
Abstract：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 specimenswith a high geometric mean titer (GMT) at day 42 after the full course of immunization and the booster, the false-negative ratewas 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.
[1] Su K, Xue J, Shan X, et al. Review of detection and quantification of rabies virus antibodies[J]. Viral Immunol,2021,34(8) :522-530. [2] 沈正君, 赵玉良, 张军, 等.狂犬病流行现状及人用狂犬病疫苗研究进展[J].实用预防医学,2020,27(5):637-640. [3] 宋云,于鹏程,朱武洋.抗狂犬病病毒中和抗体检测技术研究进展[J].国际病毒学杂志,2020,27(2):167-170. [4] 于鹏程,闫江泓,吴未辰,等.狂犬病病毒中和抗体检测试剂盒的效果评价[J].国际检验医学杂志,2016,37(23):3331-3332. [5] 张静远. 基于RABV糖蛋白膜外区的阻断ELISA抗体检测方法建立及应用[D].北京:中国人民解放军军事医学科学院,2017. [6] Yu PC,Lv XJ,Shen XX,et al. Establishment and preliminary application of a rapid fluorescent focus inhibition test (RFFIT) for rabies virus[J].Virologica Sinica,2013,28(4):223-227. [7] 徐葛林.国内外狂犬病毒实验室检测与诊断技术的研究及进展[J].中国计划免疫,2005,11(2):147-150. [8] 吕新军,王伟伟,李云云,等.采用快速荧光灶抑制试验对一种狂犬病病毒抗体竞争性ELISA检测法的评价[J].国际检验医学杂志,2011,32(6):640-641 [9] Cliquet F,Mlüler T,Mutinelli F, et al. Standardisation and establishment of a rabies ELISA test in European laboratories for assessing the efficacy of oral fox vaccination campaigns[J].Vaccine,2003,21(21/22):2986-2993. [10] 孟胜利,王传林.狂犬病疫苗免疫后中和抗体持续时间[J].中国急救复苏与灾害医学杂志,2018,13(11):1129-1133. [11] 周航, 李昱, 陈瑞丰, 等. 狂犬病预防控制技术指南(2016 版)[J]. 中华流行病学杂志, 2016,37(2):139-163. [12] 李虎,吕新军.非标准方法检测狂犬病病毒抗体阴性血清快速荧光灶抑制试验复核结果分析[J].中国急救复苏与灾害医学杂志,2019,14(3):293-295. [13] Bian L, Zhao H, He CH.et al. A time-resolved fluoroimmunoassay for assessing rabies antibody titers in the sera of vaccinated human subjects[J].Biologicals ,2020,68:54-59. [14] 谢锦荣,陈祖华,黄燕萍,等.5 423例人用狂犬病疫苗接种后血清学抗体分析[J].中华流行病学杂志,2011,32(1):90-91. [15] 吕新军,殷文武.人狂犬病病毒抗体检测技术研究进展[J].中国急救复苏与灾害医学杂志,2018,13(11):1101-1103. [16] Feyssaguet M, Dacheux L, Audry L, et al. Multicenter comparative study of a new ELISA, PLATELIATM RABIES II, for the detection and titration of anti-rabies glycoprotein antibodies and comparison with the rapid fluorescent focus inhibition test (RFFIT) on human samples from vaccinated and non-vaccinated people[J]. Vaccine, 2007, 25(12): 2244-2251. [17] Welch RJ,Anderson BL,Litwin CM. An evaluation of two commercially available ELISAs and one in-house reference laboratory ELISA for the determination of human anti-rabies virus antibodies[J].J Med Microbiol,2009,58(6):806-810. [18] Debnath A, Pathak DC, Ramamurthy N, et al. Serological profiling of rabies antibodies by enzyme-linked immunosorbent assay and its comparative analysis with rapid fluorescent focus inhibition test in mouse model[J].Vet World,2019,12(1):126-130.
2022, Vol. 29 
