Evaluation of the Immunoquick+4 malaria rapid diagnostic test in a non-endemic setting.
The aim of this retrospective study was to evaluate the Immunoquick+4 (BioSynex, Strasbourg, France), a three-band malaria rapid diagnostic test (MRDT) targeting histidine-rich protein-2 (HRP-2) and pan Plasmodium-specific parasite lactate dehydrogenase, in a non-endemic reference setting. Stored whole-blood samples (n = 613) from international travellers suspected of malaria were used, with microscopy corrected by polymerase chain reaction (PCR) as the reference method. Samples infected by P. falciparum (n = 323), P. vivax (n = 97), P. ovale (n = 73) and P. malariae (n = 25) were selected, as well as 95 malaria-negative samples. The overall sensitivities of the Immunoquick+4 for the diagnosis of P. falciparum, P. vivax, P. malariae and P. ovale were 88.9, 75.3, 56.0 and 19.2%, respectively. Sensitivity was significantly related to parasite density for P. falciparum (93.6% versus 71.4% at parasite densities >100/microl and <or=100/microl, respectively) and P. vivax (86.8% versus 48.3% at parasite densities >500/microl and <or=500/microl, respectively). The Immunoquick+4 showed good reproducibility and reliability for both test results and line intensities. The Immunoquick+4 performed well for the detection of P. falciparum and P. vivax.
Medical Microbiology, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands. D.vanDijk@student.maastrichtuniversity.nl
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D000953:Antigens, Protozoan / Q000097:blood; D016009:Chi-Square Distribution; D019353:Endemic Diseases; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D007770:L-Lactate Dehydrogenase / Q000097:blood; D008288:Malaria / Q000097:blood / Q000175:diagnosis* / Q000469:parasitology; D010961:Plasmodium / Q000302:isolation & purification; D016133:Polymerase Chain Reaction; D015800:Protozoan Proteins / Q000097:blood; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D013048:Specimen Handling; D014195:Travel
D000953:Antigens, Protozoan; C514457:HRP-2 antigen, Plasmodium falciparum; D015800:Protozoan Proteins; D011933:Reagent Kits, Diagnostic; D007770:L-Lactate Dehydrogenase