title: Short report: Failure of the OptiMAL rapid malaria test as a tool for the detection of asymptomatic malaria in an area of Thailand endemic for Plasmodium falciparum and P. vivax.
abstract: We evaluated the efficacy of the OptiMAL assay in a cross-sectional malaria survey in western Thailand from April to August 2001. Expert microscopy of Giemsa-stained thick and thin blood films was used as the gold standard. Positive control lines were evident in 99% (1,128 of 1,137) of the assays tested. However, 34% (384 of 1,128) of assays produced an aberrant result (a positive P. falciparum-specific line and a negative panmalarial line). False-positive panmalarial and Plasmodium falciparum-specific lines occurred in 25.9% (270 of 1,042) and 60.3% (628 of 1,042) of microscopy-negative samples, respectively. Due to the preponderance of false-positive test results, it was necessary to develop subjective criteria for test positivity based on line intensity. For determination of assay performance during this study, we therefore considered all test lines that were scored as intermediate or strong as positive and lines that were faint as negative. Using these criteria, we determined that the sensitivity of the OptiMAL assay for P. falciparum was 25% with > 500 parasites/microl and 10.5% with > 100 parasites/microl, while for P. vivax, the sensitivity at the same parasite rates was 100% and 41.7%, respectively. Further studies are required to determine whether the problems we identified are limited to this particular lot of OptiMAL assays.
authors.affiliation: Department of Entomology, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand. russell.coleman@det.amedd.army.mil
authors.forename: Russell E
authors.initials: RE
authors.lastname: Coleman
authors.forename: Nongnuj
authors.initials: N
authors.lastname: Maneechai
authors.forename: Alongkot
authors.initials: A
authors.lastname: Ponlawat
authors.forename: Chalermpon
authors.initials: C
authors.lastname: Kumpitak
authors.forename: Nattawan
authors.initials: N
authors.lastname: Rachapaew
authors.forename: Robert S
authors.initials: RS
authors.lastname: Miller
authors.forename: Jetsumon
authors.initials: J
authors.lastname: Sattabongkot
mesh_terms: D000818:Animals; D019353:Endemic Diseases; D006801:Humans; D007770:L-Lactate Dehydrogenase / Q000032:analysis*; D016778:Malaria, Falciparum / Q000175:diagnosis / Q000453:epidemiology* / Q000469:parasitology; D016780:Malaria, Vivax / Q000175:diagnosis / Q000453:epidemiology* / Q000469:parasitology; D008853:Microscopy; D018512:Parasitemia / Q000175:diagnosis / Q000453:epidemiology / Q000469:parasitology; D010963:Plasmodium falciparum / Q000201:enzymology / Q000302:isolation & purification; D010966:Plasmodium vivax / Q000201:enzymology / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013785:Thailand / Q000453:epidemiology; D013997:Time Factors
chemical_list: D011933:Reagent Kits, Diagnostic; D007770:L-Lactate Dehydrogenase