Photo-based External Quality Assessment of Malaria rapid diagnostic tests in a non-endemic setting.

Abstract

IntroductionIn non-endemic settings, expertise in malaria microscopy is limited and rapid diagnostic tests (RDTs) are an adjunct to malaria diagnosis.AimWe performed an External Quality Assessment (EQA) on reading and interpretation of malaria RDTs in a non-endemic setting.MethodsParticipants were medical laboratories in Belgium and the Grand Duchy of Luxembourg using malaria RDTs; they received (i) 10 high-resolution photographs presenting test line combinations of RDTs with interpretations listed in a multiple choice format and (ii) a questionnaire about their practices of malaria diagnosis.ResultsAmong 135 subscribing laboratories, 134 (99.3%) used 139 RDT products (11 different products from 8 brands). After exclusion of the results of one laboratory, analysis was done for 133 laboratories using 137 RDT products. Scores of 10/10, 9/10 and 8/10 were achieved for 58.4%, 13.1% and 8.0% of 137 RDT products respectively. For three-band P. falciparum–pan-Plasmodium RDTs (113 (82.5%) products, 6 brands), most frequent errors were (1) disregarding faint test lines (18.6%), (2) reporting invalid instead of P. falciparum (16.8%) and (3) reporting “Plasmodium spp., no further differentiation possible” without mentioning the presence or absence of P. falciparum (11.5%). For four-band RDTs (21 (15.3%) products, 1 brand), errors were (4) disregarding faint P. vivax test lines (47.6%) and (5) reporting “Plasmodium spp., no further differentiation possible” without mentioning the presence of P. falciparum and P. vivax (28.6%). Instructions for use (IFU) of only 4 out of 10 RDT products mentioned to interpret faint-intensity test lines as positive (conducive to errors 1 and 4) and IFU of 2 products displayed incorrect information (conducive to errors 2 and 5). Outside of office hours, 36.1% of participants relied on RDTs as the initial diagnostic test; 13.9% did not perform microscopic confirmation.ConclusionReading and interpretation of malaria RDTs was satisfactory, but errors were embedded in the instructions for use of the products. Relying on RDTs alone for malaria diagnosis (about one third of participants) is not a recommended practice.