General and specific limitations of RDT tests

In the case of malarial RDTs, the WHO requires a panel detection score of 75% at a parasitaemia of 200 parasites/μl in order for the product to warrant endorsement. [16] However, the threshold for pyrogenic onset has been shown to vary from 10 to 200,000 parasites/μl, with 22% of patients developing their first acute fever at a parasite load below 200/μl. [75] Thus, even for the select assortment of commercial malaria RDTs demonstrating compliance with WHO standards, sufficiently low limits of detection have not been demonstrated for the early and accurate diagnosis of nascent infections, or of asymptomatic carriers.