Rapid diagnostic devices for malaria: field evaluation of a new prototype immunochromatographic assay for the detection of Plasmodium falciparum and non-falciparum Plasmodium

Am J Trop Med Hyg. 2003 Jul;69(1):26-30.

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.

Publication types

  • Evaluation Study
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Animals
  • Female
  • Humans
  • Immunoassay / instrumentation*
  • Immunoassay / methods*
  • Malaria, Falciparum / diagnosis*
  • Malaria, Falciparum / immunology*
  • Malaria, Vivax / diagnosis
  • Malaria, Vivax / immunology
  • Male
  • Parasitemia / diagnosis
  • Parasitemia / immunology
  • Plasmodium falciparum / immunology
  • Plasmodium falciparum / isolation & purification*
  • Plasmodium vivax / immunology
  • Plasmodium vivax / isolation & purification
  • Reagent Kits, Diagnostic*
  • Sensitivity and Specificity
  • Thailand

Substances

  • Reagent Kits, Diagnostic