Kavanaugh Michael J, Azzam Steven E, Rockabrand David M
Navy Medicine Leadership and Professional Development Center, 8955 Wood Road, Building 1, Rm 1709, Bethesda, MD 20889, USA.
Department of Internal Medicine, Walter Reed National Military Medical Center, Bethesda, MD 20814, USA.
Diagnostics (Basel). 2021 Apr 25;11(5):768. doi: 10.3390/diagnostics11050768.
Malaria rapid diagnostic tests (RDTs) have had an enormous global impact which contributed to the World Health Organization paradigm shift from empiric treatment to obtaining a parasitological diagnosis prior to treatment. Microscopy, the classic standard, requires significant expertise, equipment, electricity, and reagents. Alternatively, RDT's lower complexity allows utilization in austere environments while achieving similar sensitivities and specificities. Worldwide, there are over 200 different RDT brands that utilize three antigens: Plasmodium histidine-rich protein 2 (), Plasmodium lactate dehydrogenase (pLDH), and Plasmodium aldolase (pALDO). is produced exclusively by and is very sensitive, but an alternative antigen or antigen combination is required for regions like Asia with significant prevalence. RDT sensitivity also decreases with low parasitemia (<100 parasites/uL), genetic variability, and prozone effect. Thus, proper RDT selection and understanding of test limitations are essential. The Center for Disease Control recommends confirming RDT results by microscopy, but this is challenging, due to the utilization of clinical laboratory standards, like the College of American Pathologists (CAP) and the Clinical Lab Improvement Act (CLIA), and limited recourses. Our focus is to provide quality assurance and quality control strategies for resource-constrained environments and provide education on RDT limitations.
疟疾快速诊断检测（RDTs）在全球产生了巨大影响，推动世界卫生组织从经验性治疗转向在治疗前进行寄生虫学诊断的模式转变。传统的金标准显微镜检查需要专业知识、设备、电力和试剂。相比之下，RDTs复杂度较低，可在资源匮乏的环境中使用，同时具有相似的灵敏度和特异性。全球有200多种不同品牌的RDTs，它们使用三种抗原：疟原虫富含组氨酸蛋白2（）、疟原虫乳酸脱氢酶（pLDH）和疟原虫醛缩酶（pALDO）。 仅由 产生，且非常敏感，但在 流行率较高的亚洲等地区，需要替代抗原或抗原组合。RDT的灵敏度也会因低寄生虫血症（<100个寄生虫/微升）、基因变异性和前带效应而降低。因此，正确选择RDT并了解检测局限性至关重要。疾病控制中心建议通过显微镜检查来确认RDT结果，但由于采用了美国病理学家协会（CAP）和《临床实验室改进法案》（CLIA）等临床实验室标准，且资源有限，这具有挑战性。我们的重点是为资源受限的环境提供质量保证和质量控制策略，并就RDT的局限性开展教育。
原文中部分括号内容缺失具体信息，翻译时保留了括号形式。
