Institute of Animal Hygiene and Veterinary Public Health, Leipzig University, Leipzig, Germany.
Institute of Post Graduate Medical Education and Research, Kolkata, India.
Infection. 2024 Aug;52(4):1315-1324. doi: 10.1007/s15010-024-02179-z. Epub 2024 Feb 14.
Leishmaniasis, caused by the parasite of the genus Leishmania, is a neglected tropical disease which is endemic in more than 60 countries. In South-East Asia, Brazil, and East Africa, it mainly occurs as kala-azar (visceral leishmaniasis, VL), and subsequently as post kala-azar dermal leishmaniasis (PKDL) in a smaller portion of cases. As stated per WHO roadmap, accessibility to accurate diagnostic methods is an essential step to achieve elimination. This study aimed to test the accuracy of a portable minoo device, a small battery-driven, multi-use fluorimeter operating with isothermal technology for molecular diagnosis of VL and PKDL.
Fluorescence data measured by the device within 20 min are reported back to the mobile application (or app) via Bluetooth and onward via the internet to a backend. This allows anonymous analysis and storage of the test data. The test result is immediately returned to the app displaying it to the user.
The limit of detection was 11.2 genome copies (95% CI) as determined by screening a tenfold dilution range of whole Leishmania donovani genomes using isothermal recombinase polymerase amplification (RPA). Pathogens considered for differential diagnosis were tested and no cross-reactivity was observed. For its diagnostic performance, DNA extracted from 170 VL and PKDL cases, comprising peripheral blood samples (VL, n = 96) and skin biopsies (PKDL, n = 74) from India (n = 108) and Bangladesh (n = 62), was screened. Clinical sensitivity and specificity were 88% and 91%, respectively.
Minoo devices can offer a convenient, cheaper alternative to other molecular diagnostics. Its easy handling makes it ideal for use in low-resource settings to identify parasite burden.
由利什曼原虫属寄生虫引起的利什曼病是一种被忽视的热带病，流行于 60 多个国家。在东南亚、巴西和东非，它主要表现为黑热病（内脏利什曼病，VL），随后在较小部分病例中表现为黑热病后皮肤利什曼病（PKDL）。正如世界卫生组织路线图所述，获得准确的诊断方法是实现消除的重要步骤。本研究旨在测试 minoo 设备的准确性，该设备是一种小型电池驱动的、多用途荧光计，采用等温技术进行 VL 和 PKDL 的分子诊断。
该设备在 20 分钟内测量的荧光数据通过蓝牙传输到移动应用程序（或应用程序），然后通过互联网传输到后端。这允许对测试数据进行匿名分析和存储。测试结果立即返回应用程序，显示给用户。
通过使用等温重组聚合酶扩增（RPA）筛选十倍稀释范围的整个利什曼原虫基因组，确定检测限为 11.2 个基因组拷贝（95%置信区间）。对用于鉴别诊断的病原体进行了测试，未观察到交叉反应。对于其诊断性能，从印度（n=108）和孟加拉国（n=62）的 170 例 VL 和 PKDL 病例中提取 DNA 进行了筛选，包括外周血样本（VL，n=96）和皮肤活检样本（PKDL，n=74）。临床灵敏度和特异性分别为 88%和 91%。
Minoo 设备可以提供一种方便、更便宜的替代其他分子诊断方法。其易于操作，非常适合在资源匮乏的环境中用于识别寄生虫负担。
