Uguen C, Rabodonirina M, De Pina J J, Vigier J P, Martet G, Maret M, Peyron F
Service de Parasitologie et de Pathologie exotique, Universitaire de la Croix rousse, Lyon, France.
Bull World Health Organ. 1995;73(5):643-9.
The ParaSight(R)-F test is a qualitative diagnostic test of Plasmodium falciparum, which is based on the detection by a monoclonal antibody of a species-specific soluble antigen (histidine-rich protein (HRP-II)) in whole blood and which can be performed without special equipment. A visual reading is given by a polyclonal antibody coupled with dye-loaded liposomes; when positive, a pink line appears. The test has been compared with microscopic examination of thin blood smears and with Quantitative Buffy Coat malaria test (QBC(R) in a single-blind study. A total of 358 patients who had returned to France from malarial areas and consulted their doctor with symptoms or for a routine examination were enrolled in the study; 33 of them were found to have a falciparum malaria infection by the diagnostic test. On the day of consultation, the specificity of the ParaSight(R)-F test was 99% and its sensitivity 94%. The follow-up of infected patients after treatment showed that the test became negative later than the other reference tests. There was no correlation between antigen persistence and the intensity of the ParaSight(R)-F signal or circulating parasitaemia. No cross-reaction was noted for seven malaria cases due to other Plasmodium species. The test was performed quickly (10 tests in 20 minutes), was easy to read, and required minimal space. For cases of imported malaria, the test's specificity and low threshold for detection could make it a valuable adjunct test. However, in its present form, it cannot replace microscopic techniques which are species-specific and quantitative. In endemic areas, the test seems to be very promising by its results and ease of use according to published field studies.
帕拉西特 - F检测是一种针对恶性疟原虫的定性诊断检测方法，它基于单克隆抗体对全血中一种物种特异性可溶性抗原（富含组氨酸蛋白（HRP - II））的检测，且无需特殊设备即可进行。通过与负载染料的脂质体偶联的多克隆抗体进行视觉判读；呈阳性时会出现一条粉红色线。在一项单盲研究中，该检测已与薄血涂片显微镜检查及定量血沉棕黄层疟疾检测（QBC）进行了比较。共有358名从疟疾地区返回法国并因出现症状或进行常规检查而咨询医生的患者参与了该研究；其中33人经诊断检测发现感染了恶性疟疾。在咨询当天，帕拉西特 - F检测的特异性为99%，敏感性为94%。对感染患者治疗后的随访表明，该检测转阴时间比其他参考检测晚。抗原持续存在与帕拉西特 - F信号强度或循环疟原虫血症之间无相关性。对于7例由其他疟原虫物种引起的疟疾病例，未观察到交叉反应。该检测操作快速（20分钟内可进行10次检测），易于判读，且所需空间极小。对于输入性疟疾病例，该检测的特异性和低检测阈值使其可能成为一项有价值的辅助检测方法。然而，就目前形式而言，它无法替代具有物种特异性和定量功能的显微镜技术。根据已发表的现场研究结果，在疟疾流行地区，该检测因其结果和易用性似乎非常有前景。
