Stability testing of dried Plasmodium falciparum positive quality control samples for malaria rapid diagnostic tests in Liberia and Benin.

BACKGROUND: Malaria rapid diagnostic tests (RDTs) are largely responsible for the gains made in the proportion of malaria cases confirmed with a parasitological test. However, quality assurance programs to support their use remain a challenge. A dried tube specimen (DTS) method was developed that showed potential for use as a stable source of quality control (QC) sample for RDTs and for use in external quality assessments or proficiency testing (PT). DTS was further assessed with focus on sample stability under field settings in Benin and Liberia. METHODS: DTS were prepared using Plasmodium falciparum 3D7 or W2 strains at concentrations of 1000, 500 or 0 parasites/µL and tested for baseline reactivity at the Centers for Disease Control and Prevention, Atlanta before shipping. In Benin and Liberia, DTS were stored under refrigeration in a reference laboratory (RL) or in health centres under ambient temperatures. Seven rounds of testing were performed at 4-week intervals during which DTS were tested on RDTs stored at the RL or at health centres. Observed DTS reactivity at the RL and health centres were compared to expected reactivity to determine DTS stability. DTS were also assembled into a PT panel and tested by health facility staff at the mid and end time-points of the study. Daily maximum and minimum storage temperatures for RDTs and DTS were recorded. RESULTS: In Benin, DTS, irrespective of storage conditions, produced the expected reactivity at all time points. However, evidence of degradation was observed at weeks 20 and 24 for DTS stored at ambient temperatures at the health centres and not those stored under refrigeration at the RL. In Liberia, sample degradation was observed starting at week 8 especially among DTS stored at the health facilities. The degradation was associated with prolonged storage of DTS under ambient temperature prior to study commencement and less than optimal storage temperatures at the RL. Use of DTS in a PT enabled identification of health worker errors in performing the tests. CONCLUSION: DTS is a feasible tool for use as QC material and for PT under field conditions. Long-term (> 5 months) storage of DTS requires refrigeration.

Capacity Development through the US President's Malaria Initiative-Supported Antimalarial Resistance Monitoring in Africa Network.

Antimalarial drug resistance is an evolving global health security threat to malaria control. Early detection of Plasmodium falciparum resistance through therapeutic efficacy studies and associated genetic analyses may facilitate timely implementation of intervention strategies. The US President's Malaria Initiative-supported Antimalarial Resistance Monitoring in Africa Network has assisted numerous laboratories in partner countries in acquiring the knowledge and capability to independently monitor for molecular markers of antimalarial drug resistance.

Laboratory capacity assessments in 25 African countries at high risk of yellow fever, August-December 2018.

INTRODUCTION: accurate and timely laboratory diagnosis of yellow fever (YF) is critical to the Eliminate Yellow Fever Epidemics (EYE) strategy. Gavi, the Vaccine Alliance recognized the need to support and build capacity in the national and regional laboratories in the Global YF Laboratory Network (GYFLN) as part of this strategy. METHODS: to better understand current capacity, gaps and needs of the GYFLN laboratories in Africa, assessments were carried out in national and regional reference laboratories in the 25 African countries at high risk for YF outbreaks that were eligible for new financial support from Gavi. RESULTS: the assessments found that the GYFLN in Africa has high capacity but 21% of specimens were not tested due to lack of testing kits or reagents and approximately 50% of presumptive YF cases were not confirmed at the regional reference laboratory due to problems with shipping. CONCLUSION: the laboratory assessments helped to document the baseline capacities of these laboratories prior to Gavi funding to support strengthening YF laboratories.