Department of Virology and Parasitology/Research Center for Infectious Disease Sciences, Graduate School of Medicine, Osaka Metropolitan University, 1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan.
Institute of Tropical Medicine (NEKKEN), Nagasaki University, 1-12-4 Sakamoto, NagasakiNagasaki, 852-8523, Japan.
Malar J. 2022 Sep 1;21(1):252. doi: 10.1186/s12936-022-04259-7.
Simple and accurate diagnosis is a key component of malaria control programmes. Microscopy is the current gold standard, however it requires extensive training and the results largely rely on the skill of the microscopists. Malaria rapid diagnostic tests (RDT) can be performed with minimal training and offer timely diagnosis, but results are not quantitative. Moreover, some Plasmodium falciparum parasites have evolved and can no longer be detected by existing RDT. Developed by the Sysmex Corporation, the XN-31 prototype (XN-31p) is an automated haematology analyser capable of detecting Plasmodium-infected erythrocytes and providing species differentiation and stage specific parasite counts in venous blood samples without any preparation in approximately one minute. However, factors such as stable electricity supply in a temperature-controlled room, cost of the instrument and its initial set-up, and need for proprietary reagents limit the utility of the XN-31p across rural settings. To overcome some of these limitations, a hub and spoke diagnosis model was designed, in which peripheral health facilities were linked to a central hospital where detection of Plasmodium infections by the XN-31p would take place. To explore the feasibility of this concept, the applicability of capillary blood samples with the XN-31p was evaluated with respect to the effect of sample storage time and temperature on the stability of results.
Paired capillary and venous blood samples were collected from 169 malaria-suspected outpatients in Homa Bay County Referral Hospital, Kenya. Malaria infections were diagnosed with the XN-31p, microscopy, RDT, and PCR. Capillary blood samples were remeasured on the XN-31p after 24 h of storage at either room (15-25 °C) or chilled temperatures (2-8 °C).
Identical results in malaria diagnosis were observed between venous and capillary blood samples processed immediately after collection with the XN-31p. Relative to PCR, the sensitivity and specificity of the XN-31p with capillary blood samples were 0.857 and 1.000, respectively. Short-term storage of capillary blood samples at chilled temperatures had no adverse impact on parasitaemia and complete blood counts (CBC) measured by the XN-31p.
These results demonstrate the potential of the XN-31p to improve routine malaria diagnosis across remote settings using a hub and spoke model.
简单而准确的诊断是疟疾控制规划的关键组成部分。显微镜检查是目前的金标准,但它需要广泛的培训,并且结果在很大程度上依赖于显微镜检查师的技能。疟疾快速诊断检测(RDT)可以在最少的培训下进行,并提供及时的诊断,但结果不是定量的。此外,一些恶性疟原虫寄生虫已经进化,现有的 RDT 无法再检测到。XN-31 原型(XN-31p)由希森美康公司开发,是一种自动化血液分析仪,能够在无需任何准备的情况下,大约一分钟内检测到感染了疟原虫的红细胞,并提供静脉血样中物种分化和阶段特异性寄生虫计数,但在农村地区,由于稳定的电力供应、仪器成本及其初始设置以及对专有试剂的需求等因素,限制了 XN-31p 的应用。为了克服其中的一些限制,设计了一个中心辐射式诊断模型,其中将外围卫生设施与一家中心医院连接起来,在该中心医院,通过 XN-31p 检测疟原虫感染。为了探索该概念的可行性,评估了 XN-31p 对毛细血管血样的适用性,考察了样本储存时间和温度对结果稳定性的影响。
从肯尼亚霍马贝县转诊医院的 169 例疑似疟疾的门诊患者中采集配对的毛细血管和静脉血样。用 XN-31p、显微镜检查、RDT 和 PCR 诊断疟疾感染。采集的毛细血管血样在室温(15-25°C)或冷藏温度(2-8°C)下储存 24 小时后,用 XN-31p 重新测量。
XN-31p 处理后立即采集的静脉和毛细血管血样的疟疾诊断结果完全一致。与 PCR 相比,XN-31p 检测毛细血管血样的灵敏度和特异性分别为 0.857 和 1.000。在冷藏温度下短期储存毛细血管血样对 XN-31p 测量的寄生虫血症和全血细胞计数(CBC)没有不良影响。
这些结果表明,通过中心辐射式模型,XN-31p 有可能改善偏远地区的常规疟疾诊断。