疟疾快速诊断测试（RDT）是无需仪器的测试，可在20分钟内提供结果，并且可由社区卫生工作者使用。RDT检测由疟原虫寄生虫产生的抗原，例如恶性疟原虫组氨酸富集蛋白2（PfHPR2）和乳酸疟原虫脱氢酶（pLDH）。RDT诊断简单性恶性疟原虫感染的准确性与常规显微镜相同或更高（但不如专家显微镜）。间日疟原虫的敏感性为75–100％；对于卵形疟原虫和疟原虫诊断性能差。RDT的设计局限性包括：在低寄生虫密度下灵敏度低，对前区效应的敏感性（检测PfHRP2的RDT），在pfhrp2基因缺失的情况下由于PfHRP2缺乏而导致的假阴性结果（检测PfHRP2的RDT），疟原虫抗原和检测抗体，其他感染导致的假阳性结果以及对热和湿气的敏感性。最终用户的错误与安全性，操作程序（读数延迟，样品和缓冲液体积不正确）和解释有关（无法识别无效的测试结果，忽略测试线模糊）。在RDT结果阴性的情况下，不进行抗疟药治疗的情况很少见，并且已注意到抗生素处方过度的趋势。在RDT套件的标签，使用说明（正确性和可读性）和内容中存在许多缺陷。世界卫生组织及其合作伙伴通过对RDT进行比较测试，对生产场所进行检查，很多测试和培训工具，但不存在针对最终用户性能的正式外部质量评估程序。消除疟疾需要具有较低检测限的RDT，为此正在开发核酸扩增测试。

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Malaria rapid diagnostic tests in endemic settings

Malaria rapid diagnostic tests (RDTs) are instrument-free tests that provide results within 20 min and can be used by community health workers. RDTs detect antigens produced by the Plasmodium parasite such as Plasmodium falciparum histidine-rich protein-2 (PfHPR2) and Plasmodium lactate dehydrogenase (pLDH). The accuracy of RDTs for the diagnosis of uncomplicated P. falciparum infection is equal or superior to routine microscopy (but inferior to expert microscopy). Sensitivity for Plasmodium vivax is 75–100%; for Plasmodium ovale and Plasmodium malariae, diagnostic performance is poor. Design limitations of RDTs include poor sensitivity at low parasite densities, susceptibility to the prozone effect (PfHRP2-detecting RDTs), false-negative results due to PfHRP2 deficiency in the case of pfhrp2 gene deletions (PfHRP2-detecting RDTs), cross-reactions between Plasmodium antigens and detection antibodies, false-positive results by other infections and susceptibility to heat and humidity. End-user’s errors relate to safety, procedure (delayed reading, incorrect sample and buffer volumes) and interpretation (not recognizing invalid test results, disregarding faint test lines). Withholding antimalarial treatment in the case of negative RDT results tends to be infrequent and tendencies towards over-prescription of antibiotics have been noted. Numerous shortcomings in RDT kits’ labelling, instructions for use (correctness and readability) and contents have been observed. The World Health Organization and partners actively address quality assurance of RDTs by comparative testing of RDTs, inspections of manufacturing sites, lot testing and training tools but no formal external quality assessment programme of end-user performance exists. Elimination of malaria requires RDTs with lower detection limits, for which nucleic acid amplification tests are under development.