疟疾病例复核确认过程中检测结果不一致常见问题分析

doi:10.12140/j.issn.1000-7423.2019.04.017

中国寄生虫学与寄生虫病杂志 ›› 2019, Vol. 37 ›› Issue (4): 464-471.doi: 10.12140/j.issn.1000-7423.2019.04.017

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^*()

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

收稿日期:2019-01-02 出版日期:2019-08-30 发布日期:2019-09-05
通讯作者: 周水森
作者简介:
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.
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^*()

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:2019-01-02 Online:2019-08-30 Published:2019-09-05
Contact: Shui-sen ZHOU
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/Abstract

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。

关键词: 显微镜检查, PCR, 疟疾快速诊断试剂盒, 病例确诊, 敏感性

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.

Key words: Microscopic examination, Polymerase chain reaction, Malaria rapid diagnostic test, Case confirmation, Sensitivity

中图分类号:

R531.3

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.

Mei LI, Zhi-gui XIA, Shui-sen ZHOU. Analysis of inconsistence of Plasmodium detection in some malaria cases[J]. Chinese Journal of Parasitology and Parasitic Diseases, 2019, 37(4): 464-471.

图/表 3

图1

表1

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参考文献 56

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分类	治疗至RDT阴性时的天数/d
	50%的患者显示阴性		95%的患者显示阴性
	预测平均值	95%CI	预测平均值	95%CI
RDT类型
HRP2-RDT产品	15	5~32	36	21~61
HRP2+ pLDH-RDT 产品	7	2~20	24	11~43
pLDH-RDT产品	2	1~7	10	3~24
治疗方式
ACT	8	3~21	27	13~43
非ACT	4	2~14	19	8~34
年龄
成年人	4	1~15	19	6~36
儿童	11	3~25	31	14~49

序号	镜检	PCR	RDT	首要原因^a	解决方案	结果判断
1	+	+	-	②	/	阳性,虫种以PCR为准
2	+	-	+	低原虫血症时：⑧; 高原虫血症时：⑨	原虫血症较低时,镜检结果拍照待复核,选择更敏感的PCR扩增体系再测,或属引物扩增500 bp以上DNA序列并测序;原虫血症较高时,属引物扩增500 bp以上DNA序列并测序	阳性,虫种以镜检或测序结果为准
3	+	-	-	低原虫血症时：⑧; 高原虫血症时：⑨	原虫血症较低时,镜检结果拍照待复核,选择更敏感PCR扩增体系再测,或属引物扩增500 bp以上DNA序列并测序;原虫血症较高时,属引物扩增500 bp以上DNA序列并测序	阳性,虫种以PCR或测序结果为准
4	-	+	+	①	结合临床和服药史,或未/不服用抗疟药物追踪观察至少3~6 d	阳性,虫种以PCR结果为准
5	-	+	-	①②	结合临床和服药史,或未/不服用抗疟药物追踪观察3~6 d	阳性,虫种以PCR结果为准
6	-	-	+	①⑦	选择更敏感PCR扩增体系再测,或结合临床和服药史,或未/不服用抗疟药物前提下追踪观察至少8 d	再测阳性,以PCR结果为准;再测阴性,以临床或后续追踪结果为准

疟疾病例复核确认过程中检测结果不一致常见问题分析

Analysis of inconsistence of Plasmodium detection in some malaria cases

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