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创新光学诊断设备在人体土源性线虫病和血吸虫病诊断中的研究进展:从研发到商业化。

A review on innovative optical devices for the diagnosis of human soil-transmitted helminthiasis and schistosomiasis: from research and development to commercialization.

机构信息

Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.

Centre de Recherches Medicales des Lambaréné, CERMEL, Lambaréné, Gabon.

出版信息

Parasitology. 2023 Feb;150(2):137-149. doi: 10.1017/S0031182022001664. Epub 2022 Dec 9.

DOI:10.1017/S0031182022001664
PMID:36683384
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10090604/
Abstract

Diagnosis of soil-transmitted helminth (STH) and schistosome infections relies largely on conventional microscopy which has limited sensitivity, requires highly trained personnel and is error-prone. Rapid advances in miniaturization of optical systems, sensors and processors have enhanced research and development of digital and automated microscopes suitable for the detection of these diseases in resource-limited settings. While some studies have reported proof-of-principle results, others have evaluated the performance of working prototypes in field settings. The extensive commercialization of these innovative devices has, however, not yet been achieved. This review provides an overview of recent publications (2010–2022) on innovative field applicable optical devices which can be used for the diagnosis of STH and schistosome infections. Using an adapted technology readiness level (TRL) scale taking into account the WHO target product profile (TPP) for these diseases, the developmental stages of the devices were ranked to determine the readiness for practical applications in field settings. From the reviewed 18 articles, 19 innovative optical devices were identified and ranked. Almost all of the devices (85%) were ranked with a TRL score below 8 indicating that, most of the devices are not ready for commercialization and field use. The potential limitations of these innovative devices were discussed. We believe that the outcome of this review can guide the end-to-end development of automated digital microscopes aligned with the WHO TPP for the diagnosis of STH and schistosome infections in resource-limited settings.

摘要

土壤传播性蠕虫(STH)和血吸虫感染的诊断主要依赖于传统显微镜,其灵敏度有限,需要高度训练有素的人员,且容易出错。光学系统、传感器和处理器的小型化的快速发展,增强了数字和自动化显微镜的研究和开发,这些显微镜适用于在资源有限的环境中检测这些疾病。虽然一些研究已经报告了原理验证的结果,但其他研究已经在现场环境中评估了工作原型的性能。然而,这些创新设备尚未广泛商业化。这篇综述概述了 2010 年至 2022 年期间有关可用于诊断 STH 和血吸虫感染的创新现场应用光学设备的最新出版物。使用考虑到这些疾病的世界卫生组织目标产品概况(TPP)的经改编的技术就绪水平(TRL)量表,对设备的开发阶段进行了排名,以确定其在现场环境中实际应用的准备程度。从综述的 18 篇文章中,确定并对 19 种创新光学设备进行了排名。几乎所有设备(85%)的 TRL 评分都低于 8,表明大多数设备尚未准备好商业化和现场使用。讨论了这些创新设备的潜在局限性。我们相信,该综述的结果可以指导与世界卫生组织 TPP 相一致的自动化数字显微镜的端到端开发,用于在资源有限的环境中诊断 STH 和血吸虫感染。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2daf/10268162/687b99a598fc/S0031182022001664_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2daf/10268162/8601aa6fd330/S0031182022001664_figAb.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2daf/10268162/687b99a598fc/S0031182022001664_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2daf/10268162/8601aa6fd330/S0031182022001664_figAb.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2daf/10268162/687b99a598fc/S0031182022001664_fig1.jpg

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