Nucleic amplification and microfluidic chip assay test for anti-HCV in blood samples around cutoff value by ELISA
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摘要: 目的 对于用ELISA法检测HCV-Ab结果在临界值周围的可疑标本,用核酸扩增及微流芯片法进一步检测,以探讨不同方法丙型肝炎病毒(HCV)的检出率及其感染的危险性。 方法 收集住院患者中经2种不同的HCV-Ab ELISA法试剂①或试剂②检测结果S/CO≥0.4至<1.0的血清标本24份,其金标试纸条法检测均为阴性,分别用核酸扩增及微流芯片法和化学发光免疫分析(CLIA)测HCV-Ab法进行检测。 结果 24份用ELISA法检测S/CO值处于临界值的标本,经核酸扩增及微流芯片法检测阳性16份(阳性率66.67%),CLIA测HCV-Ab法检测阳性16份(阳性率66.67%),HCV-Ab ELISA法试剂①阳性6份(阳性率25.00%),试剂②阳性10份(阳性率41.67%)。核酸扩增及微流芯片分析法与ELISA法试剂①检测结果进行比较,阳性率差异有统计学意义(P<0.01),与ELISA法试剂②检测结果进行比较,阳性率差异有统计学意义(P<0.05)。 结论 核酸扩增及微流芯片分析法对HCV的检出率高于ELISA法和金标试纸条法,因此,对ELISA法检测HCV-Ab结果在临界值周围的可疑标本,可能存在感染性,应对这些可疑标本做进一步的检测,可选择性的应用核酸扩增及微流芯片分析法和化学发光免疫分析(CLIA)法等方法联合进行检测,以提高检测结果的准确性,以防误检和漏检。
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关键词:
- 丙型肝炎病毒 /
- 核酸扩增和微流芯片分析方法 /
- CLIA法 /
- 酶联免疫吸附试验(ELISA) /
- 金标试纸条法
Abstract: Objective To investigate the efficacy of nucleic amplification and microfluidichip assay in the detection of hepatitis C virus(HCV) and judging theinfectivity of HCV in samples around Cutoff Value by ELISA. Methods Total 24 blood samples with Signal-to-Cut-Off Ratios(S/CO) values between 0.4 and 1.0 by anti-HCV ELISA and being negative by colloidal gold were collected and re-tested by using nucleic acid amplification and microfluidic chip assay and HCV CLIA. Results Among the 24 samples,16 were positive(66.67%) by nucleic acid amplification and microarray,16 were positive(66.67%) by CLIA,6 were positive(25.00%) by ELASA reagent①,and 10 were positive(41.67%) by ELISA reagent②.Nucleic acid amplification and microarray analysis were compared with the results of ELISA reagent① or reagent②,the difference in the positive rate was significant(P<0.01 and P<0.05,respectively). Conclusion Nucleicacid amplification and microfluidic chip analysis method on the detection rate of HCV is higher than that of ELISA method and colloidal gold method,therefore,the blood samples around Cutoff Value by anti-HCV ELISA assay might be with infectivity of HCV,and these samples could be tested by nucleic amplification and microfluidic chip assay or CLIA,in order to improve the detection results and prevent false detections.
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