title: Field and laboratory comparative evaluation of ten rapid malaria diagnostic tests.
abstract: The paper reports on a comparative evaluation of 10 rapid malaria tests available in South Africa in 1998: AccuCheck (AC, developmental), Cape Biotech (CB), ICT Malaria Pf (ICT1) and Pf/Pv (ICT2), Kat Medical (KAT), MakroMal (MM), OptiMAL (OP), ParaSight-F (PS), Quorum (Q), Determine-Malaria (DM). In a laboratory study, designed to test absolute detection limits, Plasmodium falciparum-infected blood was diluted with uninfected blood to known parasite concentrations ranging from 500 to 0.1 parasites per microlitre (P/microL). The 50% detection limits were: ICT1, 3.28; ICT2, 4.86; KAT, 6.36; MM, 9.37; CB, 11.42; DM, 12.40; Q, 16.98; PS, 20; AC, 31.15 and OP, 91.16 P/microL. A field study was carried out to test post-treatment specificity. Blood samples from malaria patients were tested with all products (except AC and DM) on the day of treatment and 3 and 7 days thereafter, against a gold standard of microscopy and polymerase chain reaction (PCR). OP and PS produced fewer false-positive results on day 7 (18 and 19%, respectively) than the other rapid tests (38-56%). However, microscopy, PCR, OP and PS disagreed largely as to which individuals remained positive. The tests were further compared with regard to general specificity, particularly cross-reactivity with rheumatoid factor, speed, simplicity, their ability to detect other species, storage requirements and general presentation.
authors.affiliation: Malaria Research Programme, Medical Research Council, 491 Ridge Road, P.O. Box 70380, Overport 4067, Durban, South Africa. craigm@mrc.ac.za
authors.forename: M H
authors.initials: MH
authors.lastname: Craig
authors.forename: B L
authors.initials: BL
authors.lastname: Bredenkamp
authors.forename: C H Vaughan
authors.initials: CH
authors.lastname: Williams
authors.forename: E J
authors.initials: EJ
authors.lastname: Rossouw
authors.forename: V J
authors.initials: VJ
authors.lastname: Kelly
authors.forename: I
authors.initials: I
authors.lastname: Kleinschmidt
authors.forename: A
authors.initials: A
authors.lastname: Martineau
authors.forename: G F J
authors.initials: GF
authors.lastname: Henry
mesh_terms: D000818:Animals; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards; D005260:Female; D006801:Humans; D016778:Malaria, Falciparum / Q000175:diagnosis*; D008297:Male; D010274:Parasitology / Q000592:standards*; D010963:Plasmodium falciparum / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012680:Sensitivity and Specificity; D013019:South Africa
chemical_list: D011933:Reagent Kits, Diagnostic