The rise of imported malaria cases and the high fatality rate in Europe make the search for new and easy diagnostic methods necessary. Rapid diagnosis tests (RDTs) are, in part, developed to cover the lack of diagnosis experience. Unfortunately, our data suggest that the accuracy of RDTs is insufficient and could increase the number of incorrect malaria diagnoses.In recent years, countries in which malaria is not endemic have reported high and increasing numbers of imported malaria cases, with fatalities up from 3.8 to 20% (2). Preventing fatal outcomes in malaria cases requires early recognition of infection, accurate laboratory diagnosis, and prompt therapy (2). Unfortunately, health-care personnel in countries where malaria is not endemic frequently lack experience in the microscopic diagnosis of malaria. In Italy, 80% of cases had less than a 1-week elapse between the onset of malaria symptoms and the microscopic diagnosis, but the average diagnosis took 8.5 days and the range was 1 to 28 days (3). This fact makes the search for new and easy diagnostic methods necessary. Rapid diagnosis tests (RDTs) for malaria might offer a valid alternative to microscopy (5).We studied 206 pre-and posttreatment samples from 169 patients in 1998 and 1999 by microscopic diagnosis and seminested multiplex PCR (4). These samples were also tested using three commercial RDT kits; 189 samples from 149 patients were tested with the ParaSight-F Kit (Becton Dickinson), 197 samples from 126 patients were tested with the OptiMal Kit (Flow Incorporated), and 54 samples from 41 patients were tested with the ICT Pf/Pv kit (Amrad). All patients (with ages of 16 months to 72 years) presented a history of fever and travel in the previous year to an area of malaria endemicity.RDTs were performed according to the manufacturers' instructions. All microscopy-positive samples were confirmed by PCR (4). Furthermore, PCR detected 6 samples with mixed infections (4 Plasmodium falciparum plus P. malariae and 2 P. falciparum plus P. ovale) from samples that were characterized as P. falciparum-only by microscopy and 24 more positive samples (12 P. falciparum, 4 P. ovale, 6 P. malariae, and 2 P. vivax). The three RDT methods showed a high rate of false positives and false negatives (Table 1). Moreover, 29.2% of positive non-P. falciparum samples rendered a positive P. falciparum result when the ParaSight-F test was used, which suggests a high number of cross-reactions, as this test according to the manufacturer detects only P. falciparum infections. In the same way, according to the manufacturers, the OptiMal and ICT Pf/Pv kits are able to detect P. falciparum specifically and the other Plasmodium spp. unspecifically. Our data, however, show that e Average time in which a sample is still positive by RDT (negative by microscopy and PCR) after treatment.
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