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疟疾病例复核确认过程中检测结果不一致常见问题分析

  • 李美 ,
  • 夏志贵 ,
  • 周水森
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  • 中国疾病预防控制中心寄生虫病预防控制所,国家热带病研究中心,世界卫生组织热带病合作中心,科技部国家级热带病国际联合中心,卫生部寄生虫病原与媒介生物学重点实验室,上海200025

作者简介:李美(1976-),女,博士,研究员,从事疟疾原虫学研究。E-mail:limei@nipd.chinacdc.cn.

收稿日期: 2019-01-02

  网络出版日期: 2019-09-05

基金资助

“艾滋病和病毒性肝炎等重大传染病防治”科技重大专项(No. 2018ZX10101002-002);国家卫生健康委2017年澜湄合作专项基金(No. 2020399)

Analysis of inconsistence of Plasmodium detection in some malaria cases

  • Mei LI ,
  • Zhi-gui XIA ,
  • Shui-sen ZHOU
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  • National Institute of Parasitic Diseases, Chinese Center for Diseases Control and Prevention;Chinese Center for Tropical Diseases Research;WHO Collaborating Centre for Tropical Diseases;National Center for International Research on Tropical Diseases, Ministry of Science and Technology;Key Laboratory of Parasite and Vector Biology, Ministry of Public Health, Shanghai 200025, China

Received date: 2019-01-02

  Online published: 2019-09-05

Supported by

Supported by National Important Scientific & Technology Project(No. 2018ZX10101002-002)and National Health Commission Special project for Lancang-Mekong coorperation in 2017(No. 2020399)

摘要

显微镜检查、PCR和疟疾快速诊断试剂盒(RDT)是当前普遍采用的疟原虫检测方法。国家和省级疟疾诊断参比实验室在疟疾病例的复核确认过程中,经常会出现同一份血样3种检测方法的结果不一致的情况,有时甚至会影响病例阴阳性的最终判定。为此,本文收集了与3种检测方法出现假阳性或假阴性结果的可能相关的文献资料,并结合实践经验,期望通过分析,为各相关机构在遇到类似问题时了解其中的原因和解决该问题时提供参考资料。

本文引用格式

李美 , 夏志贵 , 周水森 . 疟疾病例复核确认过程中检测结果不一致常见问题分析[J]. 中国寄生虫学与寄生虫病杂志, 2019 , 37(4) : 464 -471 . DOI: 10.12140/j.issn.1000-7423.2019.04.017

Abstract

Microscopic examination, PCR and rapid diagnostic test (RDT) are three major methods commonly used for detecting Plasmodium and diagnosing malaria. During the re-check and confirmation of diagnosis of malaria cases in national and provincial malaria diagnosis laboratories, it is common to observe the inconsistence in the results of three detection methods for the same blood sample, even reversing the final diagnosis at the end in some cases. For this reason, the literature related to the sensitivity and specificity of the three detection methods was collected and analyzed combining with our practical experience in order to provide reference for better understanding and encountering the inconsistence for those who meet the similar situation.

参考文献

[1] 中国疾病预防控制中心. 消除疟疾技术方案(2011年版)[Z]. 北京: 中国疾病预防控制中心文件, 2011.
[2] Yin JH, Yan H, Huang F, et al. Establishing a China malaria diagnosis reference laboratory network for malaria elimination[J]. Malar J, 2015, 14: 40.
[3] 李美, 燕贺, 周何军, 等. WHO对中国疟原虫镜检能力外部评估与结果分析[J]. 中国寄生虫学与寄生虫病杂志, 2018, 36(5): 499-503.
[4] World Health Organization.Malaria microscopy quality assurance manual, version 1[M]. Geneva: WHO, 2016.
[5] World Health Organization.Results of WHO product testing of malaria RDTs: round 7 (2015-2016)[M]. Geneva: WHO, 2017.
[6] 李美, 王真瑜, 张淘, 等. 一步反转录PCR技术在检测4种人疟原虫中的初步应用[J]. 中国寄生虫学与寄生虫病杂志, 2016, 34(6): 500-505.
[7] 李美, 夏志贵, 汤林华. 检测4种人体疟原虫多重PCR体系的建立和应用[J]. 中国寄生虫学与寄生虫病杂志, 2015, 33(2): 91-95.
[8] 江莉, 王真瑜, 张耀光, 等. 3种疟疾检测方法的应用分析[J]. 中国寄生虫学与寄生虫病杂志, 2017, 35(1): 53-58.
[9] Padley DJ, Heath AB, Sutherland C, et al. Establishment of the 1st World Health Organization International Standard for Plasmodium falciparum DNA for nucleic acid amplification technique (NAT)-based assays[J]. Malar J, 2008, 7: 139.
[10] Feng J, Zhang L, Huang F, et al. Ready for malaria elimination: zero indigenous case reported in the People’s Republic of China[J]. Malar J, 2018, 17: 315.
[11] Li M, Li J, Xia ZG, et al. A combined strategy for screening a clustered mobile population returning from highly endemic areas for Plasmodium falciparum[J]. J Infect Dev Ctries, 2017, 11(4): 287-293.
[12] 汤林华, 高琪, 余新炳, 等. WS259-2015 疟疾的诊断[S]. 北京: 中华人民共和国卫生和计划生育委员会, 2015.
[13] Kamau E, Tolbert LS, Kortepeter L, et al. Development of a highly sensitive genus-specific quantitative reverse transcriptase real-time PCR assay for detection and quantitation of Plasmodium by amplifying RNA and DNA of the 18S rRNA genes[J]. J Clinic Microbiol, 2011, 49(8): 2946-2953.
[14] Kamau E, Alemayehu S, Feghali KC, et al. Measurement of parasitological data by quantitative real-time PCR from controlled human malaria infection trials at the Walter Reed Army Institute of Research[J]. Malar J, 2014, 13: 288.
[15] Lee PC, Chong ETJ, Anderios F, et al. Molecular detection of human Plasmodium species in Sabah using PlasmoNexTM multiplex PCR and hydrolysis probes real-time PCR[J]. Malar J, 2015, 14: 28.
[16] Haanshuus CG and Mohn SC. Plasmodium genus-and species-specific real-time PCR using SYBR dye decreases laboratory time without impairing the sensitivity or specificity compared to conventional PCR[J]. Malar J, 2014, 13(Suppl 1): P39.
[17] N.Manca PF, Calderaro A, et al. Development of a real-time PCR assay for detection of Plasmodium falciparum, Plasmodium vivax, and Plasmodium ovale for routine clinical diagnosis[J]. J Clinic Microbiol, 2004, 42(3): 1214-1219.
[18] Alam MS, Mohon AN, Mustafa S, et al. Real-time PCR assay and rapid diagnostic tests for the diagnosis of clinically suspected malaria patients in Bangladesh[J]. Malar J, 2011, 10: 175.
[19] Jimenez A, Rees-Channer RR, Perera R, et al. Analytical sensitivity of current best in class malaria rapid diagnostic tests[J]. Malar J, 2017, 16: 128.
[20] Jang JW, Cho CH, Han ET, et al. pLDH level of clinically isolated Plasmodium vivax and detection limit of pLDH based malaria rapid diagnostic test[J]. Malaria J, 2013, 12: 181.
[21] Heutmekers M, Philippe Gillet P, Maltha J, et al. Evaluation of the rapid diagnostic test CareStart pLDH Malaria (Pf-pLDH/pan-pLDH) for the diagnosis of malaria in a reference setting[J]. Malar J, 2012, 11: 204.
[22] Piper R, Lebras J, Wentworth L, et al. Immunocapture diagnostic assays for malaria using Plasmodium lactate dehydrogenase (pLDH)[J]. Am J Trop Med Hyg, 1999, 60(1): 109-118.
[23] Bauffe F, Desplans J, Fraisier C, et al. Real-time PCR assay for discrimination of Plasmodium ovale curtisi and Plasmodium ovale wallikeri in the Ivory Coast and in the Comoros Islands[J]. Malar J, 2012, 11: 307.
[24] Baker J, McCarthy J, Gatton M, et al. Genetic diversity of Plasmodium falciparum histidine-rich protein 2 (PfHRP2) and its effect on the performance of PfHRP2-based rapid diagnostic tests[J]. J Infect Dis, 2005, 192: 870-877.
[25] World Health Organization False-negative RDT results and implications of new reports of P. falciparum histidine-rich protein 2/3 gene deletions[M]. Geneva: WHO, 2016.
[26] Simpalipan P, Pattaradilokrat S, Harnyuttanakorn P.Global sequence diversity of the lactate dehydrogenase gene in Plasmodium falciparum[J]. Malar J, 2018, 17:16.
[27] Jang IK, Tyler A, Lyman C, et al. Simultaneous quantification of Plasmodium antigens and host factor CRP in 2 asymptomatic individuals with confirmed malaria using a novel multiplex immunoassay[J]. J Clin Microbiol, 2019, 57(1): 1-11.
[28] Li B, Sun ZQ, Li XH, et al. Performance of pfHRP2 versus pLDH antigen rapid diagnostic tests for the detection of Plasmodium falciparum: a systematic review and meta-analysis[J]. Arch Med Sci, 2017, 13(3): 541-549.
[29] Wanja EW, Kuya N, Moranga C, et al. Field evaluation of diagnostic performance of malaria rapid diagnostic tests in western Kenya[J]. Malar J, 2016, 15: 456.
[30] Kakkilaya S.Rapid diagnosis of malaria[J]. Lab Med, 2003, 34(8): 602-608.
[31] Mayxay M, Pukrittayakamee S, Chotivanich K, et al. Persistence of Plasmodium falciparum HRP-2 in successfully treated acute falciparum malaria[J]. Trans R Soc Trop Med Hyg, 2001, 95: 179-182.
[32] Kyabayinze DJ, Tibenderana JK, Odong GW, et al. Operational accuracy and comparative persistent antigenicity of HRP2 rapid diagnostic tests for Plasmodium falciparum malaria in a hyperendemic region of Uganda[J]. Malari J, 2008, 7: 221.
[33] Lee JH, Jang JW, Cho CH, et al. False-positive results for rapid diagnostic tests for malaria in patients with rheumatoid factor[J]. J Clinic Microbiol, 2014, 52(10): 3784-3787.
[34] Dalrymple U, Arambepola R, Gething PW, et al. How long do rapid diagnostic tests remain positive after anti-malarial treatment?[J]. Malar J, 2018, 17: 228.
[35] Jaureguiberry G, Hatin I, d’Auriol L, et al. PCR detection of Plasmodium falciparum by oligonucleotide probes[J]. Mol Cell Probes, 1990, 4: 409-414.
[36] Kamau E, Alemayehu S, Feghali KC, et al. Multiplex qPCR for detection and absolute quantification of malaria[J]. PLoS One, 2013, 8(8): e71539.
[37] Zhao YH, Zhao Y, Lv YM, et al. Comparison of methods for detecting asymptomatic malaria infections in the China-Myanmar border area[J]. Malar J, 2017, 16: 159.
[38] Boonma P, Christensen PR, Suwanarusk R, et al. Comparison of three molecular methods for the detection and speciation of Plasmodium vivax and Plasmodium falciparum[J]. Malar J, 2007, 6: 124.
[39] Hodgson SH, Douglas AD, Edwards NJ, et al. Increased sample volume and use of quantitative reverse-transcription PCR can improve prediction of liver-to-blood inoculum size in controlled human malaria infection studies[J]. Malar J, 2015, 14: 33.
[40] Abdullah NR, Furuta T, Taib R, et al. Development of a new diagnostic method for Plasmodium falciparum infection using a reverse transcriptase-polymerase chain reaction[J]. Am J Trop Med Hyg, 1999, 54(2): 162-163.
[41] 刘季, 宋贞柱, 谢润红, 等. 大鼠死后脑组织RNA降解与死亡时间推断的研究[J].中国法医学杂志, 2007, 2(4): 226-228, 232.
[42] 黄可. 引物和探针核苷酸错配对PCR灵敏度和特异性影响的研究[D]. 扬州: 扬州大学, 2017.
[43] 杨奇奇. DNA聚合酶与引物/模板的相互作用对PCR效率的影响[D]. 上海: 复旦大学, 2013.
[44] Berry A, Benoit-Vical F, Fabre R, et al. PCR-based methods to the diagnosis of imported malaria[J]. Parasite, 2008, 15: 484-488.
[45] Snounou G, Viriyakosol S, Jarra W, et al. Identification of the four human malaria parasite species in field samples by the polymerase chain reaction and detection of a high prevalence of mixed infections[J]. Mol Biochem Parasitol, 1993, 58(2): 283-292.
[46] Tun KM, Imwong M, Lwin KM, et al.Spread of artemisinin-resistant Plasmodium falciparum in Myanmar: a cross-sectional survey of the K13 molecular marker[J]. Lancet Infect Dis, 2015, 15: 415-421.
[47] Ariey F, Witkowski B, Amaratunga C, et al. A molecular marker of artemisinin-resistant Plasmodium falciparum malaria[J]. Nature, 2014, 505(7481): 50-55.
[48] Ashley EA, Dhorda M, Fairhurst RM, et al. Spread of artemisinin resistance in Plasmodium falciparum malaria[J]. N Engl J Med, 2014, 371: 411-423.
[49] 李美, 夏志贵, 汤林华. 卵形疟原虫wallikeri亚种及其基因检测体系的研究进展[J]. 中国寄生虫学与寄生虫病杂志, 2014, 32(1): 64-67.
[50] Grigg MJ, William T, CJ Drakeley CJ, et al. Factors that are associated with the risk of acquiring Plasmodium knowlesi malaria in Sabah, Malaysia: a case-control study protocol[J]. BMJ Open, 2014, 4: e006004.
[51] Kamau E, Alemayehu S, Feghali KC, et al. Sample-ready multiplex qPCR assay for detection of malaria[J]. Malar J, 2014, 13: 158.
[52] Shokoples SE, Ndao M, Kowalewska-Grochowska K, et al. Multiplexed real-time PCR assay for discrimination of Plasmodium species with improved sensitivity for mixed infections[J]. J Clinic Microbiol, 2009, 47(4): 975-980.
[53] Khairnar K, Martin D, Lau R, et al. Multiplex real-time quantitative PCR, microscopy and rapid diagnostic immuno-chromatographic tests for the detection of Plasmodium spp: performance, limit of detection analysis and quality assurance[J]. Malar J, 2009, 8: 284.
[54] Taylor BJ, Martin KA, Arango E, et al. Real-time PCR detection of Plasmodium directly from whole blood and filter paper samples[J]. Malar J, 2011, 10: 244.
[55] Qari SH, Goldman IF, Pieniazek NJ, et al. Blood and sporozoite stage-specific small subunit ribosomal RNA-encoding genes of the human malaria parasite Plasmodium vivax[J]. Gene, 1994, 150(1): 43-49.
[56] 诸欣平, 苏川, 吴忠道. 人体寄生虫学[M]. 北京: 人民卫生出版社, 2013.
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