Department of Laboratory Medicine, Korea University, Seoul, Korea.
Trop Med Int Health. 2011 Nov;16(11):1427-31. doi: 10.1111/j.1365-3156.2011.02846.x. Epub 2011 Jul 12.
To evaluate 4 rapid malaria diagnostic kits (RDTs) in Korea: OptiMAL test, SD BIOLINE Malaria Ag P.f/Pan test, Humasis Malaria P.f/Pan antigen test and CareStart Malaria Pf/Pv Combo test.
Hundred malaria patients with Plasmodium vivax (P. vivax) and 100 healthy volunteers were recruited. The results from earlier four RDTs were compared with the reference standard, the Giemsa-stained traditional microscopic diagnosis.
Compared with the reference standard, the sensitivity and specificity for Plasmodium vivax were 92.7 and 100% for SD BIOLINE Malaria Ag P.f/Pan; and 94.6% and 100% for OptiMAL; 95.5% and 100% for both Humasis Malaria P.f/Pan antigen test and CareStart Malaria Pf/Pv Combo test.
The performances of all four malaria RDT kits were acceptable, although Humasis Malaria P.f/Pan antigen test and CareStart Malaria Pf/Pv Combo test gave superior performances with ROK isolates.
评估韩国的 4 种快速疟疾诊断试剂盒(RDTs):OptiMAL 测试、SD BIOLINE 疟疾 Ag P.f/Pan 测试、Humasis 疟疾 P.f/Pan 抗原测试和 CareStart 疟疾 Pf/Pv 联合测试。
招募了 100 名患有间日疟原虫(P. vivax)的疟疾患者和 100 名健康志愿者。将前四种 RDT 的结果与参考标准(吉姆萨染色传统显微镜诊断)进行比较。
与参考标准相比,SD BIOLINE 疟疾 Ag P.f/Pan 的灵敏度和特异性分别为 92.7%和 100%;OptiMAL 的灵敏度和特异性分别为 94.6%和 100%;Humasis 疟疾 P.f/Pan 抗原测试和 CareStart 疟疾 Pf/Pv 联合测试的灵敏度和特异性均为 95.5%和 100%。
尽管 Humasis 疟疾 P.f/Pan 抗原测试和 CareStart 疟疾 Pf/Pv 联合测试对韩国分离株的表现更优,但所有 4 种疟疾 RDT 试剂盒的性能均可接受。