Evaluation of a rapid dipstick test, Malar-Check™, for the diagnosis of Plasmodium falciparum malaria in Brazil

Abstract

The present study was carried out to evaluate the Malar-Check™ Pf test, an immunochromatographic assay that detects Plasmodium falciparum Histidine Rich Protein II, does not require equipment, and is easy and rapid to perform. In dilution assays performed to test sensitivity against known parasite density, Malar-Check™ were compared with thick blood smear (TBS), the gold standard for diagnosis. Palo Alto isolate or P. falciparum blood from patients with different parasitemias was used. The average cut-off points for each technique in three independent experiments were 12 and 71 parasites/mm3 (TBS and Malar-Check™, respectively). In the field assays, samples were collected from patients with fever who visited endemic regions. Compared to TBS, Malar-Check™ yielded true-positive results in 38 patients, false-positive results in 3, true-negative results in 23, and false-negative result in 1. Malar-Check™ performed with samples from falciparum-infected patients after treatment showed persistence of antigen up to 30 days. Malar-Check™ should aid the diagnosis of P. falciparum in remote areas and improve routine diagnosis even when microscopy is available. Previous P. falciparum infection, which can determine a false-positive test in cured individuals, should be considered. The prompt results obtained with the Malar-Check™ for early diagnosis could avoid disease evolution to severe cases.