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Background  An ultrasensitive malaria rapid diagnostic test (RDT) was recently developed for the improved detection of low-density  Plasmodium falciparum  infections. This study aimed to compare the diagnostic performance of the  Pf HRP2-based Abbott Malaria Ag  P. falciparum  ultrasensitive RDT (uRDT) to that of the conventional SD-Bioline Malaria Ag  P. falciparum  RDT (cRDT) when performed under field conditions.    Methods  Finger-prick blood samples were collected from adults and children in two cross-sectional surveys in May of 2017 in southern Mozambique. Using real-time quantitative PCR (RT-qPCR) as the reference method, the age-specific diagnostic performance indicators of the cRDT and uRDT were compared. The presence of histidine-rich protein 2 (HRP2) and  Plasmodium  lactate dehydrogenase (pLDH) antigens was evaluated in a subset from dried blood spots by a quantitative antigen assay.  pfhrp2  and  pfhrp3  gene deletions were assessed in samples positive by RT-qPCR and negative by both RDTs.    Results  Among the 4,396 participants with complete test results, the sensitivity of uRDTs (68.2; 95% CI 60.8 to 74.9) was marginally better than that of cRDTs (61.5; 95% CI 53.9 to 68.6) (p-value = 0.004), while the specificities were similar (uRDT: 99.0 [95% CI 98.6 to 99.2], cRDT: 99.2 [95% CI 98.9 to 99.4], p-value = 0.02). While the performance of both RDTs was lowest in ≥ 15-year-olds, driven by the higher prevalence of low parasite density infections in this group, the sensitivity of uRDTs was significantly higher in this age group (54.9, 95% CI 40.3 to 68.9) compared to the sensitivity of cRDTs (39.2, 95% CI 25.8 to 53.9) (p-value = 0.008). Both RDTs detected  P. falciparum  infections at similar geometric mean parasite densities (112.9  parasites/μL for uRDTs and 145.5 parasites/μL for cRDTs). The presence of HRP2 antigen was similar among false positive (FP) samples of both tests (80.5% among uRDT-FPs and 84.4% among cRDT-FPs). Only one false negative sample was detected with a partial  pfhrp2  deletion.    Conclusion  This study showed that the uRDTs developed by Abbott do not substantially outperform SD-Bioline  Pf  malaria RDTs in the community and are still not comparable to molecular methods to detect  P. falciparum  infections in this study setting.

Field performance of ultrasensitive and conventional malaria rapid diagnostic tests in southern Mozambique