丙型肝炎病毒分片段抗体检测蛋白质芯片的制备及临床评价

为了制备丙型肝炎病毒分片段抗体检测蛋白质芯片，并对其临床应用价值进行评价,将基因工程表达的丙型肝炎病毒分片段抗原，点至经特殊处理的玻片上，制成蛋白质芯片.收集来自三家临床单位用于临床验证的905份血清标本.分别用丙肝病毒分片段抗体检测蛋白质芯片、ELISA丙肝病毒抗体检测试剂进行检测.部分样本同时采用进口RIBA抗体检测试剂进行了检测，分别比较蛋白质芯片法与ELISA法以及RIBA试剂的符合率.结果表明：a.905份血清标本，ELISA法检出阳性294份，阴性611份.阳性标本用蛋白质芯片法检测，融合抗原292份显示阳性结果、2份阴性结果，根据蛋白质芯片的核心抗原，以及NS3, NS4,NS5分片段抗原综合判断确定阳性样本288份阳性，阴性样本2份，4份样本结果不确定.ELISA法检出的611份阴性标本用两种蛋白质芯片法检测，检出阴性均为611份.两种蛋白质芯片法与ELISA法的阳性符合率分别为99.3%和98.9%,与ELISA法的阴性符合率均为100%.用RIBA 试剂检测6份ELISA法为阳性，蛋白质芯片法为非阳性的样本，结果均为非阳性.b.290份经 RIBA试剂确认的阳性标本104份，单片段阳性标本66份，阴性标本120份，用蛋白质芯片法检测，检出阳性标本103份，单片段阳性标本61份，阴性标本126份，二者具有很高的符合率（P＞0.01）.丙型肝炎病毒分片段抗体检测蛋白质芯片，检测灵敏度和特异性高于ELISA法，对血清样本的确认程度与进口的RIBA试剂高度一致，具有操作简便，费用低廉的特点，是一种新型、高效的体外诊断试剂.

Preparation and Clinical Evaluation of Protein-chip for Different HCV Antibody Detection

To prepare and evaluate the clinical application of pr otein-chip for different HCV antibody detection, 905 serum samples were collected from three different hospitals. The samples were detected by ELISA method and protein-chip method respectively. Inconsistent samples were proved by imported HCV RIBA diagnostic kit. The results showed that (1)In all 905 serum samples, 294 positive samples and 611 negative samples were detected by ELISA method. Among the 294 positive samples, 292 positive samples and 2 negative samples were detected by chimeric antigen on the protein-chip and 288 positive samples, 2 negative samples, 4 indefinite samples were detected by the 4 segments of HCV antigens on the protein-chip. Among the 611 negative samples, 611 samples show negative result detected by chimeric antigen on the protein-chip and the 4 segments of HCV antigens on the protein-chip.The coordinate ratio of positive results are 99 3% and 98 9% respectively compared with ELISA method. The coordinate ratio of negative result are the same 100%. The 6 samples that were positive detemined by ELISA method and non-positive by protein-chip method were detected with RIBA reagent. All the 6 samples show non-positive result. (2)290 samples were detected with RIBA reagent. Among the 290 samples, 104 samples showed positive result, 66 samples showed positive result to single antigen segment, and 120 samples showed negative result. The 290 samples were also detected by protein-chip method. Among the 290 samples, 103 samples showed positive result, 61 samples showed positive result to single antigen segment, and 126 samples showed negative result. The result shows high coordinate ratio between the two methods (P>0 05). It can be concluded that protein-chip reagent for detection of different HCV antibodies has higher sensitivity and specific than ELISA method and has the same accuracy as imported RIBA reagent. It will be a convenient and low costs reagent for diagnosis of HCV.