title: Study and evaluation of Wondfo rapid diagnostic kit based on nano-gold immunochromatography assay for diagnosis of Plasmodium falciparum.
abstract: Malaria has been recognized as a human disease for thousands of years and remains one of the most common diseases affecting humans worldwide. Therefore, a method for rapidly detecting Plasmodium falciparum is necessary and useful. We have developed Wondfo rapid diagnostic kit based on nano-gold immunochromatography assay for the detection of P. falciparum in patient specimen. In the present study, we demonstrated the sensitivity and specificity of the rapid diagnostic kit in which nano-gold labeling techniques and the monoclonal antibodies against histidine-rich protein-2 of P. falciparum were used to establish two-antibody sandwich immunochromatographic assay for detecting P. falciparum. By using microscopic examination of blood smears as control, the sensitivity, specificity, and feasibility of Wondfo rapid diagnostic kit was determined in the prompt and accurate diagnosis of malaria. In this study, 1,558 blood samples were collected from outpatient clinics in China and detected by both Wondfo kit and microscopic examination. The Wondfo kit did not show cross-reaction with microfilaria, Toxoplasma gondii, and other parasites in the blood. The patient samples positive for rheumatoid factor, HIV, tuberculosis, and syphilis did not show false positivity when testing with Wondfo kit. The detection sensitivity and specificity of Wondfo rapid diagnostic kit were 95.49% and 99.53%, respectively. These results indicate that our rapid diagnostic assay may be useful for detecting P. falciparum in patient specimen.
authors.affiliation: School of Food and Bioengineering, South China University of Technology, Guangzhou, 510006 Guangdong, China.
authors.forename: Yunping
authors.initials: Y
authors.lastname: Peng
authors.forename: Junlin
authors.initials: J
authors.lastname: Wu
authors.forename: Jihua
authors.initials: J
authors.lastname: Wang
authors.forename: Wenmei
authors.initials: W
authors.lastname: Li
authors.forename: Shujuan
authors.initials: S
authors.lastname: Yu
mesh_terms: D000911:Antibodies, Monoclonal / Q000276:immunology / Q000378:metabolism; D002681:China; D002846:Chromatography, Affinity / Q000379:methods*; D006046:Gold; D006801:Humans; D016778:Malaria, Falciparum / Q000097:blood / Q000175:diagnosis* / Q000469:parasitology; D053768:Metal Nanoparticles / Q000737:chemistry; D010963:Plasmodium falciparum / Q000235:genetics / Q000302:isolation & purification*; D015995:Prevalence; D011506:Proteins / Q000302:isolation & purification / Q000378:metabolism; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D000099053:Histidine-Rich Glycoprotein
chemical_list: D000911:Antibodies, Monoclonal; D011506:Proteins; D011933:Reagent Kits, Diagnostic; D000099053:Histidine-Rich Glycoprotein; D006046:Gold