Elecsys HBsAg确证试验在灰区及弱反应性标本检测中的应用  

Application of Elecsys HBsAg Confirmatory Analysis in the Detection of Cutoff and Weak Reactive Samples

作　　者：姚家奎[1] 丁德坤[2] 张素华[1] 吴婷婷 成红霞[1] 

机构地区：[1]江苏省苏北人民医院,江苏扬州225001 [2]江苏国际旅行卫生保健中心扬州分中心,江苏扬州225009 [3]扬州大学,江苏扬州225009

出　　处：《现代检验医学杂志》2013年第6期106-109,共4页Journal of Modern Laboratory Medicine

摘　　要：目的探讨ElecsysHBsAg确证试验在ELISA定性试验和ECLIA定量试验临界灰区及弱反应性标本检测中的临床应用价值。方法所有被检测血清标本均来自门诊和住院患者，对其中145例ELISA法检出的灰区及弱反应性标本分别进行E1ecsysHBsAg定量试验及确证试验，并对结果进行了比较分析。结果血清HBsAg经EUSA法检测OD／CUTOFF结果在0．85～O．99之间标本共35例，其中1例ElecsysHBsAg定量及确证试验阳性占2．9％（1／35）；OD／CUTOFF结果在1．0～1．99弱反应性标本共54例，ElecsysHBsAg定量试验有反应性14例，占25．9％（14／54），ElecsysHBsAg确证试验阳性18例占33．3％（18／54）；OD／CUTOFF结果在2．0～4．99共31例，有17例ElecsysHBsAg定量及确证试验阳性占54．8％（17／31）；OD／CUTOFF结果在5．O～7．99共25例，有21例ElecsysHBsAg定量及确证试验阳性占84．0％（21／25）。通过对EuSA法与ECLIA法、ELISA法与ElecsysHBsAg确证试验检测HBsAg结果比较差异具有统计学意义（P〈O．01）。结论ELISA法检测HBsAg灰区及较低含量的弱反应性标本、可疑或乙肝感染模式不常见的标本需再次用敏感性更高的ECLIA等方法复检以防假阴性或假阳性出现，有条件的实验室可用Elect；ysHBsAg确证试验进一步确认。Objective To study the clinical application of Elecsys HBsAg confirmatory analysis in the detection of cutoff and weak reactive samples during the detection of ELISA qualitative analysis and ECLIA quantitative analysis. Methods All ser- um samples were from hospital patients and outpatients, 145 serum samples detected by ELISA were cutoff and weak reac- tive,which were compared with the results of Elecsys HBsAg quantitative test and confirmatory test. Results 35 samples with the HBsAg OD/CUTOFF of 0.85~0. 99 were detected by ELISA. Among 35 samples, 1 was reactive by Elecsys HB- sAg quantitative analysis and confirmatory test and the reactive coincidence rate was 2.9 ~ （1/35）. 54 weak reactive samples with HBsAg OD/CUTOFF of 1.0~1.99 ,the reactive coincidence rate detected by Elecsys HBsAg quantitative analysis was 25.9 ~ （14/54）, while the reactive coincidence rate detected by HBsAg confirmatory test was 33.3 ~ （18/54）. 31 weak reac- tive samples with HBsAg OD/CUTOFF of 2.0-4. 99 ,the reactive coincidence rate detected by Elecsys HBsAg quantitative analysis and confirmatory analysis was 54. 8 % （17/31）. 25 weak reactive samples with HBsAg OD/CUTOFF of 5.0-7.99, the reactive coincidence rate detected by Elecsys HBsAg quantitative analysis and confirmatory analysis was 84.0% （21/ 25）. There were significant detection difference among ELISA, ECLIA and Elecsys HBsAg confirmatory analysis （P〈 0.01）. Conclusion HBsAg cutoff and weak reactive samples detected by ELISA, and samples of suspected hepatitis B infec- tion need to be further detected by ECLIA, which was more sensible. Further detection by ECLIA was to reduce the inci- dence of false negative false positive results. Suggest that conditional laboratory can further confirm the results by Elecsys HBsAg confirmatory analysis.

关 键 词：乙肝病毒 乙肝表面抗原 酶联免疫吸附试验 电化学发光免疫分析法 HBsAg定量试验 HBsAg 确证试验 

分 类 号：R446.61[医药卫生—诊断学]