Abstract

BackgroundThe use of rapid diagnostic tests (RDTs) to diagnose malaria is common in sub-Saharan African laboratories, remote primary health facilities and in the community. Currently, there is a lack of reliable methods to ascertain health worker competency to accurately use RDTs in the testing and diagnosis of malaria. Dried tube specimens (DTS) have been shown to be a consistent and useful method for quality control of malaria RDTs; however, its application in National Quality Management programmes has been limited.MethodsA Plasmodium falciparum strain was grown in culture and harvested to create DTS of varying parasite density (0, 100, 200, 500 and 1000 parasites/µL). Using the dried tube specimens as quality control material, a proficiency testing (PT) programme was carried out in 80 representative health centres in Togo. Health worker competency for performing malaria RDTs was assessed using five blinded DTS samples, and the DTS were tested in the same manner as a patient sample would be tested by multiple testers per health centre.ResultsAll the DTS with 100 parasites/µl and 50% of DTS with 200 parasites/µl were classified as non-reactive during the pre-PT quality control step. Therefore, data from these parasite densities were not analysed as part of the PT dataset. PT scores across all 80 facilities and 235 testers was 100% for 0 parasites/µl, 63% for 500 parasites/µl and 93% for 1000 parasites/µl. Overall, 59% of the 80 healthcare centres that participated in the PT programme received a score of 80% or higher on a set of 0, 500 and 1000 parasites/ µl DTS samples. Sixty percent of health workers at these centres recorded correct test results for all three samples.ConclusionsThe use of DTS for a malaria PT programme was the first of its kind ever conducted in Togo. The ease of use and stability of the DTS illustrates that this type of samples can be considered for the assessment of staff competency. The implementation of quality management systems, refresher training and expanded PT at remote testing facilities are essential elements to improve the quality of malaria diagnosis.

Highlights

  • The use of rapid diagnostic tests (RDTs) to diagnose malaria is common in sub-Saharan African laboratories, remote primary health facilities and in the community

  • Quality control (QC) at the central laboratory The results of the QC conducted at the malaria reference laboratory showed that all aliquots of Dried tube specimens (DTS) containing 0, 500 and 1000 parasites/μl produced expected results with the SD Bioline® Malaria Ag Pf RDT

  • All DTS with 100 parasites/μl and 50% of DTS with 200 parasites/μl were classified by National Quality Assessment Programme Management (NQAPM) team as non-reactive (Fig. 2)

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Summary

Introduction

The use of rapid diagnostic tests (RDTs) to diagnose malaria is common in sub-Saharan African laboratories, remote primary health facilities and in the community. The use of rapid diagnostic tests (RDT) contributes to achieving the World Health Organization (WHO) recommendations that all patients with suspected malaria have a confirmed diagnosis prior to anti-malarial treatment initiation. RDTs are the most widely used test to diagnose malaria in suspected cases, comprising 75% of all malaria tests performed [2] The use of this type of tests allows for rapid diagnosis, which, if acted upon can enable a reduction in time between the onset of symptoms and treatment, contributing to decreased transmission, morbidity, and mortality [1]. When microscopy is not available or inconsistent, RDTs are an effective tool for the management of malaria

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