Abstract
BackgroundMalaria rapid diagnostic tests (RDTs) are increasingly used as a tool for the diagnosis of malaria, both in endemic and in non-endemic settings. The present study reports the results of an external quality assessment (EQA) session on RDTs in a non-endemic setting.MethodsAfter validation of antigen stability during shipment at room temperature, three clinical samples and a questionnaire were sent to clinical laboratories in Belgium and the Grand Duchy of Luxembourg using malaria RDTs. Participants were asked to report the results of the RDTs as observations (visibility of the RDT control and test lines) and interpretations (report as formulated to the clinician). In addition, participants were invited to fill in a questionnaire on the place of RDTs in the diagnostic strategy of malaria.ResultsA total of 128/133 (96.2%) of clinical laboratories using RDTs participated. Six three-band and one four-band RDT brands were used. Analytical errors were rare and included (i) not recognizing invalid RDT results (1.6%) and (ii) missing the diagnosis of Plasmodium falciparum (0.8%). Minor errors were related to RDT test result interpretation and included (i) reporting "RDT positive" without species identification in the case of P. falciparum and non-falciparum species (16.9% and 6.5% respectively) and (ii) adding incorrect comments to the report (3.2%). Some of these errors were related to incorrect RDT package insert instructions such as (i) not reporting the possibility of mixed species infection in the case of P. falciparum and Plasmodium vivax (35.5% and 18.5% respectively) and (ii) the interpretation of P. vivax instead of non-falciparum species at the presence of a pan-species antigen line (4.0%). According to the questionnaire, 48.8% of participants processed ≤20 requests for malaria diagnosis in 2009. During opening hours, 93.6% of 125 participants used RDTs as an adjunct to microscopy but outside opening hours, nearly one third of 113 participants relied on RDTs as the primary (4.4%) or the single tool (25.7%) for malaria diagnosis.ConclusionIn this non-endemic setting, errors in RDT performance were mainly related to RDT test line interpretations, partly due to incorrect package insert instructions. The reliance on RDTs as the primary or the single tool for the diagnosis of malaria outside opening hours is of concern and should be avoided.
Highlights
Malaria rapid diagnostic tests (RDTs) are increasingly used as a tool for the diagnosis of malaria, both in endemic and in non-endemic settings
Participants, samples and questionnaire The present external quality assessment (EQA) session was organized among clinical laboratories in Belgium and the Grand Duchy of Luxembourg which had declared to be interested in EQA sessions on malaria rapid diagnostic tests when subscribing to the EQA session “Blood Parasites” or “Microbiology” organized by the Institute of Public Health, Brussels, Belgium
The present study reports the findings of an EQA session on malaria RDTs in a non-endemic setting
Summary
Malaria rapid diagnostic tests (RDTs) are increasingly used as a tool for the diagnosis of malaria, both in endemic and in non-endemic settings. In non-endemic settings, where microscopic expertise is lacking due to low incidence, RDTs have been reported to perform accurately and even better as compared to microscopy [2,3]. Despite their robust design and their ease of use, RDTs are not fail-proof and quality problems have been identified at the level of production, transport and storage as well as at the level of the end-user’s performance [4,5,6,7,8,9,10]. In light of these reasons, the present EQA was organized
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
