Evaluation of a rapid diagnostic test specific for Plasmodium vivax

Evaluation of a rapid diagnostic test specific for Plasmodium vivax
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DOI:
10.1111/j.1365-3156.2008.02163.x
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发表时间:
2008-12-01
影响因子:
3.3
通讯作者:
Lim, Chae Seung
Lim, Chae Seung
中科院分区:
医学4区
文献类型:
--
作者:
Kim, Sun Hyung;Nam, Myung-Hyun;Lim, Chae Seung

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间日疟原虫是韩国唯一的人类疟疾。检测间日疟原虫的快速敏感诊断试验(RDT)适用于评估无国外旅行史的疑似疟疾患者。在282名志愿者中比较了RDTs、间日疟原虫特异性SD疟疾抗原P.v(SD diagnostic,Kyonggi,ROK)和文献充分的OptiMAL(DiaMed,Cressier,Switzerland)之间的间日疟原虫和恶性疟原虫疟疾感染对Giemsa染色血涂片的特异性和敏感性,由经验丰富的显微镜医师读取。共有137名志愿者被诊断为间日疟原虫,45例(从海外返回的旅行者)被诊断为恶性疟原虫,100名健康志愿者被诊断为疟疾阴性。相应地,SD疟疾抗原P.v检测在137名疟疾患者中的128名(93.4%)和100名健康志愿者中的0名(0%)中鉴定出间日疟原虫感染。3名被鉴定为恶性疟原虫的患者也通过SD疟疾抗原P.v检测被解释为间日疟原虫;然而,这些患者后来通过聚合酶链反应被证实为间日疟原虫和恶性疟原虫的混合感染。OptiMAL仅将三种混合感染解释为恶性疟原虫,并检测到130/137(94.9%)例间日疟原虫患者。随着寄生虫血症水平的下降,SD疟疾抗原P.v试验的灵敏度从100%(> 5000个寄生虫/μ l)下降到81.3%(1-100个寄生虫/μ l)。对于间日疟原虫是主要疟疾寄生虫的地区,当没有足够的物质和人力资源(例如受过培训的显微镜检查员)用于疟疾诊断时,SD间日疟原虫特异性快速诊断测试可能有助于筛查疑似疟疾患者。
Plasmodium vivax is the only human malaria indigenous to the Republic of Korea (ROK). A rapid and sensitive diagnostic test (RDT) that detects P. vivax is appropriate for evaluating suspected malaria patients with no travel history abroad. The RDTs, SD Malaria Antigen P.v (SD diagnostic, Kyonggi, ROK) specific for P. vivax and the well documented OptiMAL (DiaMed, Cressier, Switzerland) were compared among 282 volunteers for specificity and sensitivity of P. vivax and Plasmodium falciparum malaria infections against Giemsa-stained blood smears read by an experienced microscopist. A total of 137 volunteers were diagnosed with P. vivax, 45 cases (returned travellers from overseas) were diagnosed with P. falciparum and 100 healthy volunteers were diagnosed as negative for malaria. Correspondingly, the SD Malaria Antigen P.v test identified P. vivax infections in 128/137 malaria patients (93.4%) and 0/100 (0%) healthy volunteers. Three patients identified with P. falciparum also were interpreted as P. vivax by the SD Malaria Antigen P.v test; however, these patients were later confirmed as mixed infections of P. vivax and P. falciparum by polymerase chain reaction. OptiMAL interpreted the three mixed infections only as P. falciparum and detected 130/137 (94.9%) patients with P. vivax. The sensitivity of the SD Malaria Antigen P.v test decreased from 100% (> 5000 parasite/mu l) to 81.3% (1-100 parasites/mu l) as parasitaemia levels declined. For the regions where P. vivax is the primary malaria parasite, the SD P. vivax-specific rapid diagnostic test may be useful for screening suspected malaria patients when sufficient material and human resources (e.g. trained microscopists) are unavailable for malaria diagnosis.