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

Towards harmonization of microscopy methods for malaria clinical research studies

Mehul Dhorda  1   2   3 , El Hadji Ba  4 , J Kevin Baird  5   6 , John Barnwell  7 , David Bell  8 , Jane Y Carter  9 , Arjen Dondorp  5   10 , Lenny Ekawati  6 , Michelle Gatton  11 , Iveth González  12 , Philippe J Guérin  5   13 , Sandra Incardona  14 , Ken Lilley  15 , Didier Menard  16 , François Nosten  10   17 , Peter Obare  18 , Bernhards Ogutu  18 , Piero L Olliaro  5 , Ric N Price  5   10   13   19 , Stéphane Proux  10   17 , Andrew R Ramsay  20 , John C Reeder  21 , Kamolrat Silamut  10 , Cheikh Sokhna  4 ; Research Malaria Microscopy Working Group
Affiliations
Review

Towards harmonization of microscopy methods for malaria clinical research studies

Mehul Dhorda et al. Malar J. .

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: Clinical research; Diagnostic; Harmonization; Malaria; Microscopy; Standard.

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Conflict of interest statement

All authors declare they have no competing interests.

Figures

Fig. 1
Fig. 1
Recommended procedural adjustments to reduce variability in the detection, identification and quantification of malaria parasites by microscopy. The size of the thick film in printed versions of the template above must be verified before use
See this image and copyright information in PMC

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