Journal Article

Towards harmonization of microscopy methods for malaria clinical research studies

Lilley, Ken, Proux, Stéphane, Ogutu, Bernhards, Olliaro, Piero L., Menard, Didier, González, Iveth, Silamut, Kamolrat, Price, Ric N., Sokhna, Cheikh, Obare, Peter, Dhorda, Mehul, Dondorp, Arjen, Carter, Jane Y., Reeder, John C., Kevin Baird, J., Ekawati, Lenny, Ba, El Hadji, Incardona, Sandra, Barnwell, John, Ramsay, Andrew R., Bell, David, Guérin, Philippe J., Gatton, Michelle, Nosten, François

2020

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Biomedical and Life Sciences / Biomedicine / Blood / Care and treatment / Clinical research / Clinical trials / Diagnosis / Diagnostic / Diagnostic Tests, Routine / Diagnostic Tests, Routine - methods / Diagnostic Tests, Routine - standards / Entomology / Estimates / Evaluation / Forecasts and trends / Geography / Harmonization / Human diseases / Human health and pathology / Humans / Identification / Infectious Diseases / Laboratory Proficiency Testing / Laboratory Proficiency Testing - methods / Laboratory Proficiency Testing - standards / Life Sciences / Malaria / Malaria - parasitology / Medical research / Medical societies / Microbiology / Microbiology and Parasitology / Microscopy / Microscopy - methods / Microscopy - standards / Parasites / Parasitology / Peripheral blood / Procedures / Public Health / Quality assurance / Quality Control / Quality standards / Reproducibility of Results / Research proposals / Review / Sensitivity and Specificity / Staining and Labeling / Staining and Labeling - methods / Staining and Labeling - standards / Test reliability / Training / Tropical diseases / Tropical Medicine / Vaccines / Vector-borne diseases / Workloads