Test characteristics of the SD FK80 Plasmodium falciparum/Plasmodium vivax malaria rapid diagnostic test in a non-endemic setting.
BACKGROUND
The SD FK80 P.f/P.v Malaria Antigen Rapid Test (Standard Diagnostics, Korea) (FK80) is a three-band malaria rapid diagnostic test detecting Plasmodium falciparum histidine-rich protein-2 (HRP-2) and Plasmodium vivax-specific lactate dehydrogenase (Pv-pLDH). The present study assessed its performance in a non-endemic setting.


METHODS
Stored blood samples (n = 416) from international travellers suspected of malaria were used, with microscopy corrected by PCR as the reference method. Samples infected by Plasmodium falciparum (n = 178), Plasmodium vivax (n = 99), Plasmodium ovale (n = 75) and Plasmodium malariae (n = 24) were included, as well as 40 malaria negative samples.


RESULTS
Overall sensitivities for the diagnosis of P. falciparum and P. vivax were 91.6% (95% confidence interval (CI): 86.2% - 95.0%) and 75.8% (65.9% - 83.6%). For P. falciparum, sensitivity at parasite densities >or= 100/microl was 94.6% (88.8% - 97.6%); for P. vivax, sensitivity at parasite densities >or= 500/microl was 86.8% (75.4% - 93.4%). Four P. falciparum samples showed a Pv-pLDH line, three of them had parasite densities exceeding 50.000/microl. Two P. vivax samples, one P. ovale and one P. malariae sample showed a HRP-2 line. For the HRP-2 and Pv-pLDH lines, respectively 81.4% (136/167) and 55.8% (43/77) of the true positive results were read as medium or strong line intensities. The FK80 showed good reproducibility and reliability for test results and line intensities (kappa values for both exceeding 0.80).


CONCLUSIONS
The FK80 test performed satisfactorily in diagnosing P. falciparum and P. vivax infections in a non-endemic setting.
Gillet
Philippe
P
Department of Clinical Medicine, Institute of Tropical Medicine, Nationalestraat 155, B 2000 Antwerp, Belgium. pgillet@itg.be
van Dijk
David P J
DP
Bottieau
Emmanuel
E
Cnops
Lieselotte
L
Van Esbroeck
Marjan
M
Jacobs
Jan
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D000953:Antigens, Protozoan / Q000302:isolation & purification; D002648:Child; D002675:Child, Preschool; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007223:Infant; D007770:L-Lactate Dehydrogenase; D016778:Malaria, Falciparum / Q000175:diagnosis* / Q000453:epidemiology / Q000469:parasitology; D016780:Malaria, Vivax / Q000175:diagnosis* / Q000453:epidemiology / Q000469:parasitology; D008297:Male; D008853:Microscopy / Q000379:methods; D008875:Middle Aged; D010963:Plasmodium falciparum / Q000276:immunology / Q000302:isolation & purification*; D010966:Plasmodium vivax / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods; D011506:Proteins; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D014195:Travel; D055815:Young Adult; D000099053:Histidine-Rich Glycoprotein
D000953:Antigens, Protozoan; D011506:Proteins; D011933:Reagent Kits, Diagnostic; D000099053:Histidine-Rich Glycoprotein; D007770:L-Lactate Dehydrogenase