Service de Parasitologie et Mycologie Médicale, Groupement Hospitalier Nord, Hospices Civils de Lyon,69004 Lyon,France - Université de Lyon, Université Lyon 1, CNRS, INSA, CPE-Lyon, ICBMS, UMR 5246,69100 Villeurbanne,France.
Service des Maladies Infectieuses et Tropicales, Hôpital de la Croix-Rousse, Hospices Civils de Lyon,69004 Lyon,France.
Parasite. 2022;29:31. doi: 10.1051/parasite/2022031. Epub 2022 May 31.
Malaria diagnosis based on microscopy is impaired by the gradual disappearance of experienced microscopists in non-endemic areas. Aside from the conventional diagnostic methods, fluorescence flow cytometry technology using Sysmex XN-31, an automated haematology analyser, has been registered to support malaria diagnosis. The aim of this prospective, monocentric, non-interventional study was to evaluate the diagnostic accuracy of the XN-31 for the initial diagnosis or follow-up of imported malaria cases compared to the reference malaria tests including microscopy, loop mediated isothermal amplification, and rapid diagnostic tests. Over a one-year period, 357 blood samples were analysed, including 248 negative and 109 positive malaria samples. Compared to microscopy, XN-31 showed sensitivity of 100% (95% CI: 97.13-100) and specificity of 98.39% (95% CI: 95.56-100) for the initial diagnosis of imported malaria cases. Moreover, it provided accurate species identification asfalciparumor non-falciparumand parasitaemia determination in a very short time compared to other methods. We also demonstrated that XN-31 was a reliable method for patient follow-up on days 3, 7, and 28. Malaria diagnosis can be improved in non-endemic areas by the use of dedicated haematology analysers coupled with standard microscopy or other methods in development, such as artificial intelligence for blood slide reading. Given that XN-31 provided an accurate diagnosis in 1 min, it may reduce the time interval before treatment and thus improve the outcome of patient who have malaria.
基于显微镜的疟疾诊断在非流行地区因经验丰富的显微镜专家逐渐减少而受到影响。除了传统的诊断方法外，使用Sysmex XN-31 自动化血液分析仪的荧光流式细胞术技术已被注册用于支持疟疾诊断。这项前瞻性、单中心、非干预性研究的目的是评估 XN-31 对输入性疟疾病例的初始诊断或随访的诊断准确性，与包括显微镜检查、环介导等温扩增和快速诊断测试在内的参考疟疾测试进行比较。在一年的时间里，分析了 357 个血液样本，包括 248 个阴性和 109 个阳性疟疾样本。与显微镜检查相比，XN-31 对输入性疟疾病例的初始诊断具有 100%的敏感性（95%CI：97.13-100）和 98.39%的特异性（95%CI：95.56-100）。此外，与其他方法相比，XN-31 能够在很短的时间内提供准确的物种鉴定（恶性疟原虫或非恶性疟原虫）和寄生虫血症的确定。我们还证明，XN-31 是一种可靠的方法，可用于患者在第 3、7 和 28 天的随访。通过使用专用血液分析仪结合标准显微镜检查或其他正在开发的方法（如用于血涂片阅读的人工智能），可以改善非流行地区的疟疾诊断。由于 XN-31 在 1 分钟内提供了准确的诊断，它可以减少开始治疗之前的时间间隔，从而改善患有疟疾的患者的预后。
