迈向疟疾临床研究中显微镜方法的统一。

Towards harmonization of microscopy methods for malaria clinical research studies.

机构信息

WorldWide Antimalarial Resistance Network, 60th Anniversary Chalermprakhiat Building 3rd Floor, 420/6 Ratchawithi Road, Ratchathewi, Bangkok, 10400, Thailand.

Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.

出版信息

Malar J. 2020 Sep 4;19(1):324. doi: 10.1186/s12936-020-03352-z.

Abstract

Microscopy performed on stained films of peripheral blood for detection, identification and quantification of malaria parasites is an essential reference standard for clinical trials of drugs, vaccines and diagnostic tests for malaria. The value of data from such research is greatly enhanced if this reference standard is consistent across time and geography. Adherence to common standards and practices is a prerequisite to achieve this. The rationale for proposed research standards and procedures for the preparation, staining and microscopic examination of blood films for malaria parasites is presented here with the aim of improving the consistency and reliability of malaria microscopy performed in such studies. These standards constitute the core of a quality management system for clinical research studies employing microscopy as a reference standard. They can be used as the basis for the design of training and proficiency testing programmes as well as for procedures and quality assurance of malaria microscopy in clinical research.

摘要

对末梢血涂片进行染色以检测、鉴定和定量疟原虫,这是对疟疾药物、疫苗和诊断检测进行临床试验的重要参考标准。如果这种参考标准在时间和地域上保持一致,那么此类研究的数据价值将大大提高。要实现这一点,就必须遵守共同的标准和做法。本文提出了用于制备、染色和镜检血液中疟原虫的建议研究标准和程序,目的是提高此类研究中进行的疟疾显微镜检查的一致性和可靠性。这些标准构成了采用显微镜作为参考标准的临床研究质量管理系统的核心。它们可作为培训和能力验证计划的设计基础,以及临床研究中疟疾显微镜检查的程序和质量保证的基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d62f/7471592/43aeb6fd2bc4/12936_2020_3352_Fig1_HTML.jpg

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