5种RDTs检测间日疟原虫和卵形疟原虫效果评价及影响因素研究  

Evaluation of five RDTs for detecting Plasmodium vivax and Plasmodium ovale and analysis of influencing factors

作　　者：许艳[1] 王龙江 陈春梅 李林林[3] 隋苗苗[4] 孔祥礼[1] 张本光[1] 李曰进 闫歌[1] 王用斌[1] XU Yan;WANG Long-jiang;CHEN Chun-mei;LI Lin-lin;SUI Miao-miao;KONG Xiang-li;ZHANG Ben-guang;LI Yue-jin;YAN Ge;WANG Yong-bin(Shandong Institute of Parasitic Diseases,Shandong First Medical University&Shandong Academy of Medical Sciences,Jining,Shandong 272033,China;Rencheng Center for Disease Control and Prevention,Jining City;Zaozhuang Center for Disease Control and Prevention;Weihai Center for Disease Control and Prevention)

机构地区：[1]山东省寄生虫病防治研究所,山东第一医科大学(山东省医学科学院),山东济宁272033 [2]济宁市任城区疾病预防控制中心 [3]枣庄市疾病预防控制中心 [4]威海市疾病预防控制中心

出　　处：《中国病原生物学杂志》2022年第9期1040-1044,共5页Journal of Pathogen Biology

基　　金：山东省医药卫生科技发展计划项目(No.202001050530,202001050586)。

摘　　要：目的评价5种常见疟疾快速诊断试剂盒(RDTs)对间日疟原虫和卵形疟原虫的检测效果,并分析影响检测结果的因素,为医疗机构选择和应用RDTs提供参考依据。方法按照各试剂盒说明书操作,分别用万孚、BinaxNOW、SD、蓝十字和伊仕5种RDTs检测间日疟确诊病例血样、卵形疟确诊病例血样和阴性血样。采用诊断试验的方法,评价5种RDTs检测间日疟原虫和卵形疟原虫的灵敏度和特异度,比较不同RDTs检测灵敏度间的差异。并分析卵形疟亚型、感染来源对RDTs检测结果的影响。结果万孚、BinaxNOW、SD、蓝十字和伊仕5种RDTs检测间日疟原虫的灵敏度分别为85.71%、88.57%、82.86%、88.57%和91.43%,且两两间的差异均无统计学意义(均P>0.05);5种RDTs检测间日疟原虫的特异度分别为100.00%、100.00%、100.00%、100.00%和94.74%。万孚、BinaxNOW和SD 3种RDTs检测卵形疟原虫的灵敏度分别为75.70%、48.60%和1.87%,两两间的差异均有统计学意义(均P<0.01);3种RDTs检测卵形疟原虫的特异度均为100.00%。万孚、BinaxNOW和SD 3种RDTs检测Po-c和Po-w两种卵形疟亚型的灵敏度差异均无统计学意义(均P>0.05),3种RDTs对不同非洲区域卵形疟原虫检测灵敏度的差异亦均无统计学意义(均P>0.05)。结论万孚、BinaxNOW、SD、蓝十字和伊仕5种RDTs检测间日疟原虫的效果均较理想,除万孚检测卵形疟原虫的灵敏度相对较高外,暂未发现卵形疟亚型和感染来源是影响RDTs检测效果的因素。Objective To evaluate the effect of five common RDTs for detecting Plasmodium vivax and Plasmodium ovale,and to analyze the factors influencing the detection effects,so as to provide references for the selection and application of RDTs in medical institutions.Methods According to the instructions of each kit,blood samples from confirmed cases of P.vivax and P.ovale and negative blood samples were detected by RDTs of Wondfo,BinaxNOW,SD,Blue CROSS and EGENS,respectively.The sensitivities and specificities of the five RDTs for detection of Plasmodium vivax and Plasmodium ovale were evaluated by diagnostic tests,and the differences of sensitivities among different RDTs were compared.The influences of P.ovale subtype and infection sources on the detection effect of RDTs were analyzed.And SPSS 26.0 software was used to statistical analysis.Results The sensitivities of Wondfo,BinaxNOW,SD,Blue CROSS and EGENS for detecting P.vivax were 85.71%,88.57%,82.86%,88.57%and 91.43%,respectively,and there were no significant differences between them(all P>0.05).The specificities of the five RDTs for detection of P.vivax were 100.00%,100.00%,100.00%,100.00%and 94.74%,respectively.The sensitivities of Wondfo,BinaxNOW and SD for detection of P.ovale were 75.70%,48.60%and 1.87%,respectively,and the differences were statistically significant(all P<0.01).The specificities of the three RDTs for P.ovale detection were all 100.00%.There was no significant differences in the sensitivities of Wondfo,BinaxNOW and SD in detecting Po-c and Po-w subtypes(all P>0.05),and there was no significant differences in the sensitivities of the three RDTs in detecting P.ovale from different African regions(all P>0.05).Conclusion Wondfo,BinaxNOW,SD,Blue CROSS and EGENS all showed good detection effect for P.vivax.While the detecting effect of BinaxNOW and SD were not satisfactory except for the comparatively high sensitivity of Wondfo in detecting P.ovale.The subtypes of P.ovale and the infection source have not been found to be the factors influencing the

关 键 词：疟疾快速诊断试剂盒(RDTs) 间日疟原虫 卵形疟原虫 灵敏度 特异度 影响因素 

分 类 号：R382.31[医药卫生—医学寄生虫学]