比较疟疾的快速诊断检验
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By LabMedica International staff writers Posted on 28 Jun 2018 |
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图片：Deki读片仪是一台结实的体外诊断设备，与通称为快速诊断检验的市售侧流免疫测定配套使用（图片蒙Fio公司惠赐）。
疟疾病例的诊疗包括早期的诊断和及时的有效治疗，它仍是疟疾控消战略的一个要素。虽然显微镜检是标准的疟疾诊断工具及金标准，但却不被频繁使用，因为资源贫乏地区的化验场地没有配备显微镜，还缺少技术娴熟的读片员。
现在提倡医疗机构使用快速诊断检验(RDT)来替代或者辅助显微镜检，因为医疗工作者只需接受较少培训、使用较少设备就能轻松使用，还可由非专业人员在远程操控。RDT能快速给出结果，便于患者的初次治疗和后续治疗。
一组来自多国的科学家与坦桑尼亚莫希市的乞力马扎罗基督教医科大学学院(http://kcmuco.ac.tz)合作，从1,423名过去24小时内报告发烧和/或其它疟疾症状、腋下体温≥ 37.5 °C的门诊病人中招募了1,293人。参与研究者的年龄中值为21岁，大多数参与者(71.4%; 923/1293)年龄从18岁到24岁。三分之二强(69.1%; 893/1293)是男性。
这项研究使用了韩国龙仁市标准诊断股份有限公司(www.alere.com)的SD Bioline疟疾抗原Pf/pan RDT诊断疟疾，它可检测PfHRP2（恶性疟原虫）与pLDH (pan)，同时还做了显微镜检。由经验丰富的高级显微镜检师检查染过色的涂片。加拿大安大略省多伦多市Fio公司的Deki读片仪(DR, http://fio.com)能提供自动化序列程序，引导操作人员执行RDT检验。该设备捕获一帧图像并识别出RDT的记号后，提示用户从设备中拿出RDT，再从患者身上抽血。
Deki读片仪解读疟疾快速诊断检验结果的灵敏度为94.1%，而目测的灵敏度为93.9%。疟疾快速诊断检验结果的特异性为71.8%，而人眼解读的特异性为72.0%。Deki读片仪和目测解读疟疾RDT结果的阳性预测值分别为75.8和75.4%，而阴性预测值分别为92.8和92.4%。DR和目测解读RDT的准确率分别为82.6和82.1%。
该研究的论文发表于2018年5月29日的《疟疾杂志》(Malaria Journal)。作者总结说，自动化DR与无经验医疗工作者的目测解读RDT的效果没有显著差异。然而，虽然该设备性能参数相近，但确实有用，因为它能一步一步引导用户处理RDT、数据传输以及上报。
标准诊断股份有限公司>>> www.alere.com
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