Department of Laboratory Medicine, Korea University College of Medicine, Seoul 08308, Korea.
Department of Diagnostic Immunology, Seegene Medical Foundation, Seoul 04805, Korea.
Korean J Parasitol. 2021 Feb;59(1):77-82. doi: 10.3347/kjp.2021.59.1.77. Epub 2021 Feb 19.
As malaria remains a major health problem worldwide, various diagnostic tests have been developed, including microscopy-based and rapid diagnostic tests. LabChip real-time PCR (LRP) is a small and portable device used to diagnose malaria using lab-on-a-chip technology. This study aimed to evaluate the diagnostic performance of LRP for detecting malaria parasites. Two hundred thirteen patients and 150 healthy individuals were enrolled from May 2009 to October 2015. A diagnostic detectability of LRP for malaria parasites was compared to that of conventional RT-PCR. Sensitivity of LRP for Plasmodium vivax, P. falciparum, P. malariae, and P. ovale was 95.5%, 96.0%, 100%, and 100%, respectively. Specificity of LRP for P. vivax, P. falciparum, P. malariae, and P. ovale was 100%, 99.3%, 100%, and 100%, respectively. Cohen's Kappa coefficients between LRP and CFX96 for detecting P. vivax, P. falciparum, P. malariae, and P. ovale were 0.96, 0.98, 1.00, and 1.00, respectively. Significant difference was not observed between the results of LRP and conventional RT-PCR and microscopic examination. A time required to amplify DNAs using LRP and conventional RT-PCR was 27 min and 86 min, respectively. LRP amplified DNAs 2 times more fast than conventional RT-PCR due to the faster heat transfer. Therefore, LRP could be employed as a useful tool for detecting malaria parasites in clinical laboratories.
由于疟疾仍然是全球主要的健康问题，已经开发了各种诊断测试，包括基于显微镜和快速诊断测试。LabChip 实时 PCR（LRP）是一种小型便携式设备，用于使用芯片上实验室技术诊断疟疾。本研究旨在评估 LRP 检测疟原虫的诊断性能。2009 年 5 月至 2015 年 10 月期间，共招募了 213 名患者和 150 名健康个体。比较了 LRP 对疟疾寄生虫的诊断检测能力与传统 RT-PCR 的检测能力。LRP 对间日疟原虫、恶性疟原虫、卵形疟原虫和三日疟原虫的敏感性分别为 95.5%、96.0%、100%和 100%。LRP 对间日疟原虫、恶性疟原虫、卵形疟原虫和三日疟原虫的特异性分别为 100%、99.3%、100%和 100%。LRP 与 CFX96 检测间日疟原虫、恶性疟原虫、卵形疟原虫和三日疟原虫的 Cohen's Kappa 系数分别为 0.96、0.98、1.00 和 1.00。LRP 与传统 RT-PCR 和显微镜检查的结果之间没有观察到显著差异。使用 LRP 和传统 RT-PCR 扩增 DNA 所需的时间分别为 27 分钟和 86 分钟。由于热传递更快，LRP 比传统 RT-PCR 快 2 倍地扩增 DNA。因此，LRP 可以作为临床实验室检测疟原虫的有用工具。
