title: Rapid diagnostic devices for malaria: field evaluation of a new prototype immunochromatographic assay for the detection of Plasmodium falciparum and non-falciparum Plasmodium.
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.
authors.affiliation: Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand. chansuda@namru2.med.navy.mil
authors.forename: Chansuda
authors.initials: C
authors.lastname: Wongsrichanalai
authors.forename: Iracema
authors.initials: I
authors.lastname: Arevalo
authors.forename: Anintita
authors.initials: A
authors.lastname: Laoboonchai
authors.forename: Kritsanai
authors.initials: K
authors.lastname: Yingyuen
authors.forename: R Scott
authors.initials: RS
authors.lastname: Miller
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Magill
authors.forename: J Russ
authors.initials: JR
authors.lastname: Forney
authors.forename: Robert A
authors.initials: RA
authors.lastname: Gasser
mesh_terms: D000328:Adult; D000818:Animals; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation* / Q000379:methods*; D016778:Malaria, Falciparum / Q000175:diagnosis* / Q000276:immunology*; D016780:Malaria, Vivax / Q000175:diagnosis / Q000276:immunology; D008297:Male; D018512:Parasitemia / Q000175:diagnosis / Q000276:immunology; D010963:Plasmodium falciparum / Q000276:immunology / Q000302:isolation & purification*; D010966:Plasmodium vivax / Q000276:immunology / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013785:Thailand
chemical_list: D011933:Reagent Kits, Diagnostic