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评估OptiMAL检测法用于间日疟原虫和恶性疟原虫疟疾快速诊断的效果。

Evaluation of the OptiMAL test for rapid diagnosis of Plasmodium vivax and Plasmodium falciparum malaria.

作者信息

Palmer C J, Lindo J F, Klaskala W I, Quesada J A, Kaminsky R, Baum M K, Ager A L

机构信息

Center for Disease Prevention, University of Miami School of Medicine, Florida 33136, USA.

出版信息

J Clin Microbiol. 1998 Jan;36(1):203-6. doi: 10.1128/JCM.36.1.203-206.1998.

Abstract

The development of rapid and specific diagnostic tests to identify individuals infected with malaria is of paramount importance in efforts to control the severe public health impact of this disease. This study evaluated the ability of a newly developed rapid malaria diagnostic test, OptiMAL (Flow Inc., Portland, Oreg.), to detect Plasmodium vivax and Plasmodium falciparum malaria during an outbreak in Honduras. OptiMAL is a rapid (10-min) malaria detection test which utilizes a dipstick coated with monoclonal antibodies against the intracellular metabolic enzyme parasite lactate dehydrogenase (pLDH). Differentiation of malaria parasites is based on antigenic differences between the pLDH isoforms. Since pLDH is produced only by live Plasmodium parasites, this test has the ability to differentiate live from dead organisms. Results from the OptiMAL test were compared to those obtained by reading 100 fields of traditional Giemsa-stained thick-smear blood films. Whole-blood samples were obtained from 202 patients suspected of having malaria. A total of 96 samples (48%) were positive by blood films, while 91 (45%) were positive by the OptiMAL test. The blood films indicated that 82% (79 of 96) of the patients were positive for P. vivax and 18% (17 of 96) were infected with P. falciparum. The OptiMAL test showed that 81% (74 of 91) were positive for P. vivax and 19% (17 of 91) were positive for P. falciparum. These results demonstrated that the OptiMAL test had sensitivities of 94 and 88% and specificities of 100 and 99%, respectively, when compared to traditional blood films for the detection of P. vivax and P. falciparum malaria. Blood samples not identified by OptiMAL as malaria positive normally contained parasites at concentrations of less than 100/microl of blood. Samples found to contain P. falciparum were further tested by two other commercially available rapid malaria diagnostic tests, ParaSight-F (Becton Dickinson, Cockeysville, Md.) and ICT Malaria P.f. (ICT Diagnostics, Sydney, Australia), both of which detect only P. falciparum. Only 11 of the 17 (65%) P. falciparum-positive blood samples were identified by the ICT and ParaSight-F tests. Thus, OptiMAL correctly identified P. falciparum malaria parasites in patient blood samples more often than did the other two commercially available diagnostic tests and showed an excellent correlation with traditional blood films in the identification of both P. vivax malaria and P. falciparum malaria. We conclude that the OptiMAL test is an effective tool for the rapid diagnosis of malaria.

摘要

开发快速、特异的诊断检测方法以识别感染疟疾的个体,对于控制这种疾病对公众健康造成的严重影响至关重要。本研究评估了一种新开发的快速疟疾诊断检测方法OptiMAL(Flow Inc.,俄勒冈州波特兰市)在洪都拉斯一次疟疾暴发期间检测间日疟原虫和恶性疟原虫的能力。OptiMAL是一种快速(10分钟)疟疾检测方法,它利用一种涂有针对细胞内代谢酶寄生虫乳酸脱氢酶(pLDH)的单克隆抗体的试纸条。疟原虫的鉴别基于pLDH同工型之间的抗原差异。由于pLDH仅由活的疟原虫产生,该检测方法有能力区分活的和死的生物体。将OptiMAL检测结果与通过读取100个传统吉姆萨染色厚血膜视野获得的结果进行比较。从202名疑似患有疟疾的患者中采集全血样本。血膜检测共96份样本(48%)呈阳性,而OptiMAL检测有91份(45%)呈阳性。血膜显示,82%(96份中的79份)的患者间日疟原虫呈阳性,18%(96份中的17份)感染了恶性疟原虫。OptiMAL检测显示,81%(91份中的74份)间日疟原虫呈阳性,19%(91份中的17份)恶性疟原虫呈阳性。这些结果表明,与传统血膜检测间日疟原虫和恶性疟原虫相比,OptiMAL检测的灵敏度分别为94%和88%,特异性分别为100%和99%。OptiMAL未鉴定为疟疾阳性的血样通常每微升血液中寄生虫浓度低于100个。发现含有恶性疟原虫的样本通过另外两种市售快速疟疾诊断检测方法进一步检测,即ParaSight-F(Becton Dickinson,马里兰州科基斯维尔)和ICT Malaria P.f.(ICT Diagnostics,澳大利亚悉尼),这两种方法仅检测恶性疟原虫。在17份恶性疟原虫阳性血样中,只有11份(65%)被ICT和ParaSight-F检测方法鉴定出来。因此,OptiMAL在患者血样中正确鉴定恶性疟原虫的次数比其他两种市售诊断检测方法更多,并且在鉴定间日疟原虫和恶性疟原虫方面与传统血膜显示出极好的相关性。我们得出结论,OptiMAL检测是快速诊断疟疾的有效工具。

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