Rapid diagnostic devices for malaria: field evaluation of a new prototype immunochromatographic assay for the detection of Plasmodium falciparum and non-falciparum Plasmodium.
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.
Wongsrichanalai
Chansuda
C
Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand. chansuda@namru2.med.navy.mil
Arevalo
Iracema
I
Laoboonchai
Anintita
A
Yingyuen
Kritsanai
K
Miller
R Scott
RS
Magill
Alan J
AJ
Forney
J Russ
JR
Gasser
Robert A
RA
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
D011933:Reagent Kits, Diagnostic