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<p>Abstract</p> <p>Background</p> <p>Accurate diagnosis of malaria is an essential prerequisite for proper treatment and drug resistance monitoring. Microscopy is considered the gold standard for malaria diagnosis but has limitations. ELISA, PCR, and Real Time PCR are also used to diagnose malaria in reference laboratories, although their application at the field level is currently not feasible. Rapid diagnostic tests (RDTs) however, have been brought into field operation and widely adopted in recent days. This study evaluates <it>OnSite</it> (Pf/Pan) antigen test, a new RDT introduced by CTK Biotech Inc, USA for malaria diagnosis in a reference setting.</p> <p>Methods</p> <p>Blood samples were collected from febrile patients referred for malaria diagnosis by clinicians. Subjects were included in this study from two different Upazila Health Complexes (UHCs) situated in two malaria endemic districts of Bangladesh. Microscopy and nested PCR were considered the gold standard in this study. <it>OnSite</it> (Pf/Pan) RDT was performed on preserved whole blood samples.</p> <p>Results</p> <p>In total, 372 febrile subjects were included in this study. Of these subjects, 229 (61.6%) tested positive for <it>Plasmodium</it> infection detected by microscopy and nested PCR. <it>OnSite</it> (Pf/Pan) RDT was 94.2% sensitive (95% CI, 89.3-97.3) and 99.5% specific (95% CI, 97.4-00.0) for <it>Plasmodium falciparum</it> diagnosis and 97.3% sensitive (95% CI, 90.5-99.7) and 98.7% specific (95% CI, 96.6-99.6) for <it>Plasmodium vivax</it> diagnosis. Sensitivity varied with differential parasite count for both <it>P. falciparum</it> and <it>P. vivax</it>. The highest sensitivity was observed in febrile patients with parasitaemia that ranged from 501–1,000 parasites/μL regardless of the <it>Plasmodium</it> species.</p> <p>Conclusion</p> <p>The new <it>OnSite</it> (Pf/Pan) RDT is both sensitive and specific for symptomatic malaria diagnosis in standard laboratory conditions.</p>