Towards harmonization of microscopy methods for malaria clinical research studies
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Malaria Journal Open Access
REVIEW
Towards harmonization of microscopy methods for malaria clinical research studies Mehul Dhorda1,2,3* , El Hadji Ba4, J. Kevin Baird2,5, John Barnwell6, David Bell7, Jane Y. Carter8, Arjen Dondorp2,3, Lenny Ekawati5, Michelle Gatton9, Iveth González10, Philippe J. Guérin2,11, Sandra Incardona12, Ken Lilley13, Didier Menard14, François Nosten3,15, Peter Obare16^, Bernhards Ogutu16, Piero L. Olliaro2, Ric N. Price2,3,11,17, Stéphane Proux3,15, Andrew R. Ramsay18, John C. Reeder19, Kamolrat Silamut3 and Cheikh Sokhna4 on behalf of Research Malaria Microscopy Working Group
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. Keywords: Malaria, Microscopy, Harmonization, Clinical research, Diagnostic, Standard Background Microscopy continues to play an important role in malaria diagnosis and in research studies. While the advent of rapid diagnostic tests have reduced its importance as a primary diagnostic test in routine practice in some countries, microscopy remains an essential tool to support clinical research, severe malaria case management and monitoring of anti-malarial treatment efficacy [1]. In the specific context of drug efficacy trials, assessments of in-use and new drugs depend on high-quality microscopy to differentiate Plasmodium species and
stages, and estimate parasite density [2]. Microscopy is likely to remain relevant in drug efficacy monitoring as initial signs of resistance to anti-malarial drugs are commonly seen first through a reduction in parasite clearance rate [3, 4]. A particular case is that of resistance to artemisinins, since the only currently available method for its detection in vivo is the measurement of parasite clearance rates, a procedure that requires repeated accurate, precise, and standardized estimations of parasite density in peripheral blood. Furthermore, malaria vaccine trials commonly use malaria parasite detection by microscopy
*Correspondence: [email protected] ^ Peter Obare—Deceased 1 WorldWide Antimalarial Resistance Network, 60th Anniversar
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