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发明公开
CN106053800A 一种结核病血清学诊断试剂盒 无效 - 驳回

一种结核病血清学诊断试剂盒
摘要：
本发明提供了一种结核病血清学诊断试剂盒，该试剂盒中至少包括包被液、洗涤液、封闭液和终止液，还包含以下组分：重组蛋白rRv0220，其氨基酸序列如SEQ ID NO.1所示；重组蛋白rRv2958c，其氨基酸序列如SEQ ID NO.2所示。本发明所提供的两种重组蛋白均具有良好的免疫反应性，能与其诱导的小鼠产生的抗体发生特异结合。两种重组蛋白均能与结核病患者血清发生特异结合，经间接ELISA法检测，与胶体金法(38‑16KDa)比较，rRv0220的特异性、敏感性和总符合率分别为98.6％，98.3％和98.4％；rRv2985c的特异性、敏感性和总符合率分别为100％，96.5％和98.4％，说明两种重组蛋白具有高度的敏感性与特异性，能够作为结核病血清学诊断的优选抗原。
摘要（英）：

The invention provides a tuberculosis serological diagnostic kit, at least comprising a coating solution, a washing solution, a sealing solution and a stop solution and also comprising the following components: recombinant protein rRv0220, having an amino acid sequence shown as in SEQ ID NO. 1; recombinant protein rRv2958c, having an amino acid sequence shown as in SEQ ID NO. 2. Both the two recombinant proteins provided herein have good immunoreactivity and can specifically bind with mouse-produced antibodies induced by the proteins. Both the two recombinant proteins can specifically bind with serum of a tuberculosis patient; indirect ELISA detection shows that when compared with colloidal gold process (38-16 KDa), rRv0220 has specificity, sensitivity and total accordance respectively of 98.6%, 98.3% and 98.4%, and rRv2985c has specificity, sensitivity and total accordance respectively of 100%, 96.5% and 98.4%, and it is indicated that the two recombinant proteins have high sensitivity and specificity and can function as preferred antigens for tuberculosis serological diagnosis.

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