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十种用于检测……的商用快速诊断检测试剂盒敏感性的比较评估

Comparative Assessment of the Sensitivity of Ten Commercial Rapid Diagnostic Test Kits for the Detection of .

作者信息

Gendrot Mathieu, Madamet Marylin, Fonta Isabelle, Benoit Nicolas, Amalvict Rémy, Mosnier Joel, Pradines Bruno

机构信息

Unité Parasitologie et Entomologie, Département de Microbiologie et Maladies Infectieuses, Institut de Recherche Biomédicale des Armées, 13005 Marseille, France.

Aix Marseille University, IRD, AP-HMM, SSA, VITROME, 13005 Marseille, France.

出版信息

Diagnostics (Basel). 2022 Sep 16;12(9):2240. doi: 10.3390/diagnostics12092240.

Abstract

Malaria is one of the most common tropical diseases encountered by members of the French military who are deployed in operations under constrained conditions in malaria-endemic areas. Blood smear microscopy-the gold standard for malaria diagnosis-is often not available in such settings, where the detection of malaria relies on rapid diagnostic tests (RDTs). Ten RDTs (from Biosynex, Carestart, Humasis, SD Bioline, and CTK Biotech), based on the detection of the histidine-rich protein 2 (HRP2) or lactate dehydrogenase (pLDH, PfLDH, or PvLDH), were assessed against 159 samples collected from imported malaria cases, including 79 , 37 , 22 , and 21 parasites. Samples had been previously characterised using microscopy and real-time PCR. The overall sensitivities for the test ranged from 69.8% (111/159) to 95% (151/159). There was no significant difference for the specific detection of (96.2% to 98.7%, = 0.845). No significant difference was found between sensitivities to by pan LDH or pvLDH (81.1% (30/37) to 94.6% (35/37) ( = 0.845)). Some of the RDTs missed most of and , with sensitivities for all RDTs ranging respectively from 4.5% (1/22) to 81.8% (18/22) and 14.3% (3/21) to 95.2% (20/21). Carestart Malaria Pf/Pan (pLDH) Ag G0121, a pLDH-based RDT (PfLDH and pLDH), showed the highest sensitivities to (98.7%, 78/79), (94.6%, 35/37), (81.8%, 18/22), and (95.2%, 20/21) and meets the requirements for military deployments in malaria-endemic areas.

摘要

疟疾是法国军人在疟疾流行地区执行受限条件下的行动任务时最常遇到的热带疾病之一。血液涂片显微镜检查是疟疾诊断的金标准,但在这些地区往往无法进行,疟疾检测依赖于快速诊断检测(RDT)。基于检测富含组氨酸蛋白2(HRP2)或乳酸脱氢酶(pLDH、PfLDH或PvLDH),对来自10种RDT(来自Biosynex、Carestart、Humasis、SD Bioline和CTK Biotech)针对159份输入性疟疾病例样本进行了评估,其中包括79例、37例、22例和21例疟原虫。样本此前已通过显微镜检查和实时PCR进行了鉴定。该检测的总体灵敏度范围为69.8%(111/159)至95%(151/159)。在的特异性检测方面没有显著差异(96.2%至98.7%,P = 0.845)。泛LDH或pvLDH对的灵敏度之间没有发现显著差异(81.1%(30/37)至94.6%((35/37),P = 0.845)。一些RDT遗漏了大部分和,所有RDT对的灵敏度分别为4.5%(1/22)至81.8%(18/22),对的灵敏度为14.3%(3/21)至95.2%(20/21)。基于pLDH的RDT Carestart Malaria Pf/Pan(pLDH)Ag G0121(PfLDH和pLDH)对、、和显示出最高灵敏度(分别为98.7%,78/79;94.6%,35/37;81.8%,18/22;95.2%,20/21),符合疟疾流行地区军事部署的要求。

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