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用于诊断人类并殖吸虫病的内部斑点印迹酶联免疫吸附测定试剂盒的多实验室盲法评估。

Blinded multi-laboratory evaluation of an in-house dot-blot ELISA kit for diagnosis of human parastrongyliasis.

作者信息

Eamsobhana Praphathip, Yoolek Adisak, Kreethapon Nibhon

机构信息

Department of Parasitology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Southeast Asian J Trop Med Public Health. 2003 Mar;34(1):1-6.

PMID:12971507
Abstract

An in-house membrane dot-blot enzyme-linked immunosorbent assay kit, for the detection of specific antibody to a 31 kDa protein of Parastrongylus cantonensis was evaluated in a blinded multi-laboratory study. The kit was provided to technologists, who were trained in its use, from nine regional laboratories of Thailand. With an identical set of 20 coded serum samples and reference positive and negative controls, the kit was found to have a diagnostic sensitivity of 100% and a diagnostic specificity of 100% in all the laboratories. There was no obvious variation in quality among five lots of the antigen-coated nitrocellulose strips evaluated. The shelf life of the kit was > or = 6 months when the test components were stored at 4 degrees C and 18 months at -20 degrees C. The enzyme-linked immunoassay dot technique is easy to perform and does not require sophisticated electrical equipment; the result is available within 3 hours. If appropriate technical training is included, the application of this dot-blot ELISA kit in clinical laboratories throughout Thailand should be possible.

摘要

在一项多实验室盲法研究中,对一种用于检测广州管圆线虫31 kDa蛋白特异性抗体的内部膜斑点酶联免疫吸附测定试剂盒进行了评估。该试剂盒提供给来自泰国9个地区实验室的技术人员,这些技术人员均接受过使用培训。使用一组相同的20份编码血清样本以及参考阳性和阴性对照,发现在所有实验室中该试剂盒的诊断敏感性为100%,诊断特异性为100%。在所评估的五批抗原包被硝酸纤维素条之间,质量没有明显差异。当测试组件储存在4℃时,试剂盒的保质期≥6个月;储存在-20℃时,保质期为18个月。酶联免疫测定斑点技术操作简便,不需要复杂的电气设备;3小时内即可获得结果。如果包含适当的技术培训,这种斑点酶联免疫吸附测定试剂盒在泰国各地临床实验室的应用应该是可行的。

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