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目的探讨电化学发光免疫分析法(chemiluminescence immunoassay,CLIA)及酶联免疫吸附试验(enzymelinked immunosorbent assay,ELISA)用于丙型肝炎病毒(hepatitis C virus,HCV)抗体检测的效果。方法收集2014年1月—2015年12月采用CLIA法和ELISA法检测HCV抗体结果可疑的血清标本,最终以重组免疫印迹法(recombinant immunoblot assay,RIBA)确诊丙型肝炎(丙肝)感染血清63例,比较CLIA法和ELISA法检测HCV抗体阳性的符合率,分析CLIA法中低值组(10.05)。经RIBA试验及CLIA法检测同时确诊的61例HCV抗体阳性标本中,低值组检测HCV抗体阳性率为24.59%(15/61),明显低于高值组的90.16%(55/61),差异有统计学意义(χ~2=53.626,P<0.05)。结论 CLIA法和ELISA法均可用于HCV抗体的检测,CLIA法阳性符合率相对较高,可作为HCV一种常规检测方法,但应对S/CO值较低者进一步使用RIBA检查确认,以降低漏检率。
Objective To investigate the effect of chemiluminescence immunoassay (CLIA) and enzyme linked immunosorbent assay (ELISA) on the detection of hepatitis C virus (HCV) antibody. Methods A total of 63 serum samples of patients with hepatitis C (HCV) infection were collected from January 2014 to December 2015 by CLIA assay and ELISA assay. Serum samples from patients with suspected hepatitis C virus (HCV) were detected by recombinant immunoblot assay (RIBA) . The coincidence rates of CLIA assay and ELISA assay were analyzed. The positive rate of CLIA assay in low value group (1 0.05). The positive rate of HCV antibody in low-value group was 24.59% (15/61), which was significantly lower than that in high-value group (90.16%, 55/61) in 61 HCV antibody-positive specimens diagnosed simultaneously by RIBA test and CLIA test. The difference was statistically significant (χ ~ 2 = 53.626, P <0.05). Conclusions Both CLIA and ELISA can be used for the detection of HCV antibodies. The positive coincidence rate of CLIA method is relatively high, which can be used as a routine detection method for HCV. However, further RIBA tests should be performed to confirm the lower S / CO values to reduce the leakage Rate.