RAPID DIAGNOSTIC DEVICES FOR MALARIA: FIELD EVALUATION OF A NEW PROTOTYPE IMMUNOCHROMATOGRAPHIC ASSAY FOR THE DETECTION OF PLASMODIUM FALCIPARUM AND NON-FALCIPARUM PLASMODIUM

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Abstract
The NOW® ICT Malaria P.f./P.v. for Whole Blood (Binax, Inc., Portland, ME) is a new malaria rapid diagnostic device that represents a technical advance over previous assays, such as ICT™ Malaria P.f./P.v. and ICT™ Malaria P.f.. We evaluated this device in March 2001 in symptomatic patients at malaria clinics in Maesod, Thailand. Microscopic examination of Giemsa-stained blood smears was the reference standard. In 246 patients, microscopy showed 32 (13.0%) infected with Plasmodium falciparum, 63 (25.6%) with P. vivax, 6 (2.4%) with mixed infections of P. falciparum and P. vivax, 5 (2.0%) with P. malariae, and 140 (56.9%) negative. Sensitivity for P. falciparum was 100% and specificity was 96.2% (200 of 208; 95% confidence interval [CI] = 92–98). For P. vivax, sensitivity was 87.3% (55 of 63; 95% CI = 77–93) and specificity was 97.7% (173 of 177; 95% CI = 95–99), but all the four false-positive results were microscopically positive for P. malariae; thus, specificity for non-falciparum Plasmodium was 100%. These results suggest improved performance over NOW® ICT predecessors.

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