Malaria rapid diagnostic devices:: Performance characteristics of the ParaSight F device determined in a multisite field study
Malaria rapid diagnostic devices:: Performance characteristics of the ParaSight F device determined in a multisite field study
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DOI：
10.1128/jcm.39.8.2884-2890.2001
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发表时间：
2001-08-01
影响因子：
9.4
通讯作者：
Gasser, RA
中科院分区：
文献类型：
--
作者：
Forney, JR;Magill, AJ;Gasser, RA
几十年来，寄生虫的显微镜检测一直是疟疾诊断的参考标准。然而，在维持所需的技术技能和基础设施的困难，刺激了几个非微观疟疾快速诊断设备的基础上检测全血中的疟原虫抗原的发展。ParaSight F测试就是这样一种设备。它通过使用抗原捕获免疫层析条形式检测恶性疟原虫特异性富组氨酸蛋白2的存在。本研究在秘鲁的伊基托斯和泰国的Maesod的疟疾门诊进行。采用一式两份、设盲、专家显微镜检查作为评价器械性能的参考标准。在2，988名合格患者中，显微镜检查显示547名（18%）患有恶性疟原虫，658名（22%）患有间日疟原虫，2名（0.07%）患有三日疟原虫，1，750名（59%）对疟原虫呈阴性。在31名患者（1%）中确定了混合感染（恶性疟原虫和间日疟原虫）。ParaSight F对恶性疟原虫的总体灵敏度为95%。当按寄生虫血症的程度（每微升全血中无性寄生虫的数量）分层时，灵敏度分别为83%（>0至500个寄生虫/穆尔）、87%（501至1，000个/穆尔）、98%（1，001至5，000个/穆尔）和98%（> 5，000个/穆尔）。器械特异性为86%。
Microscopic detection of parasites has been the reference standard for malaria diagnosis for decades. However, difficulty in maintaining required technical skills and infrastructure has spurred the development of several nonmicroscopic malaria rapid diagnostic devices based on the detection of malaria parasite antigen in whole blood. The ParaSight F test is one such device. It detects the presence of Plasmodium falciparum-specific histidine-rich protein 2 by using an antigen-capture immunochromatographic strip format. The present study was conducted at outpatient malaria clinics in Iquitos, Peru, and Maesod, Thailand. Duplicate, blinded, expert microscopy was employed as the reference standard for evaluating device performance. Of 2,988 eligible patients, microscopy showed that 547 (18%) had P. falciparum, 658 (22%) had P. vivax, 2 (0.07%) had P. malariae, and 1,750 (59%) were negative for Plasmodium. Mixed infections (P. falciparum and P. vivax) were identified in 31 patients (1%). The overall sensitivity of ParaSight F for P. falciparum was 95%. When stratified by magnitude of parasitemia (no. of asexual parasites per microliter of whole blood), sensitivities were 83% (>0 to 500 parasites/mul), 87% (501 to 1,000/mul), 98% (1,001 to 5,000/mul), and 98% (>5,000/mul). Device specificity was 86%.