U.S. Public Health Service and Malaria Branch, Centers for Disease Control and Prevention, Atlanta, Georgia 30341, USA.
Am J Trop Med Hyg. 2010 Jan;82(1):151-5. doi: 10.4269/ajtmh.2010.09-0440.
Histidine-rich protein II (HRP2)-based malaria rapid diagnostic tests (RDTs) have shown high sensitivity and specificity for detecting Plasmodium falciparum malaria in a variety of study settings. However, RDTs are susceptible to heat and humidity and variation in individual performance, which may affect their use in field settings. We evaluated sensitivity and specificity of RDTs during routine use for malaria case management in peripheral health facilities. From December 2007 to October 2008, HRP2-based ParaHIT-f RDTs were introduced in 12 facilities without available microscopy in Rufiji District, Tanzania. Health workers received a single day of instruction on how to perform an RDT and thick blood smear. Job aids, Integrated Management of Childhood Illness guidelines, and national malaria treatment algorithms were reviewed. For quality assurance (QA), thick blood smears for reference microscopy were collected for 2 to 3 days per week from patients receiving RDTs; microscopy was not routinely performed at the health facilities. Slides were stained and read centrally within 72 hours of collection by a reference microscopist. When RDT and blood smear results were discordant, blood smears were read by additional reference microscopists blinded to earlier results. Facilities were supervised monthly by the district laboratory supervisor or a member of the study team. Ten thousand six hundred fifty (10,650) patients were tested with RDTs, and 51.5% (5,488/10,650) had a positive test result. Blood smear results were available for 3,914 patients, of whom 40.1% (1,577/3,914) were positive for P. falciparum malaria. Overall RDT sensitivity was 90.7% (range by facility 85.7-96.5%) and specificity was 73.5% (range 50.0-84.3%). Sensitivity increased with increasing parasite density. Successful implementation of RDTs was achieved in peripheral health facilities with adequate training and supervision. Quality assurance is essential to the adequate performance of any laboratory test. Centralized staining and reading of blood smears provided useful monitoring of RDT performance. However, this level of QA may not be sustainable nationwide.
富含组氨酸蛋白 2（HRP2）的疟疾快速诊断检测（RDT）已被证明在各种研究环境下对检测恶性疟原虫疟疾具有高敏感性和特异性。然而，RDT 易受温度和湿度以及个体性能变化的影响，这可能会影响它们在现场环境中的使用。我们评估了 RDT 在常规使用中用于管理周边卫生设施中的疟疾病例的敏感性和特异性。从 2007 年 12 月至 2008 年 10 月，坦桑尼亚 Rufiji 区的 12 个无显微镜设施引入了基于 HRP2 的 ParaHIT-f RDT。卫生工作者接受了为期一天的关于如何进行 RDT 和厚血涂片的培训。参考了综合儿童疾病管理指南和国家疟疾治疗算法。为了质量保证（QA），每周从接受 RDT 的患者中收集 2-3 天的参考显微镜厚血涂片；卫生设施没有常规进行显微镜检查。收集后 72 小时内，由参考显微镜专家在中心对载玻片进行染色和阅读。当 RDT 和血涂片结果不一致时，由其他参考显微镜专家对血涂片进行阅读，这些专家对先前的结果并不知情。每月由区实验室主管或研究团队的成员对各设施进行监督。用 RDT 对 10650 名患者进行了检测，其中 51.5%（5488/10650）的检测结果呈阳性。有 3914 名患者的血涂片结果可用，其中 40.1%（1577/3914）为恶性疟原虫疟疾阳性。总的 RDT 敏感性为 90.7%（各设施的范围为 85.7-96.5%），特异性为 73.5%（范围为 50.0-84.3%）。敏感性随寄生虫密度的增加而增加。在经过充分培训和监督的周边卫生设施中成功实施了 RDT。质量保证对于任何实验室测试的充分性能都是至关重要的。血涂片的集中染色和阅读为 RDT 性能提供了有用的监测。然而，这种级别的 QA 可能无法在全国范围内持续。
