【摘要】 目的比较国产全自动酶免分析系统与进口酶免分析系统及手工操作方法三者间检测性能方面的差异。方法 2016年于杭州市第一人民医院随机收集的乙型肝炎、丙型肝炎阴性血清标本各196份,乙型肝炎、丙型肝炎阳性血清标本各20份。1套珠海丽珠公司乙肝检测试剂盒和1套北京康彻斯坦公司抗HBV国家标准物质,1套北京万泰丙肝试剂盒和1套北京康彻斯坦公司抗HCV国家标准物质,分别于国产全自动酶免分析系统、雅培i2000SR和手工操作平行试验,测定吸光度值,计算3种方法的灵敏度、精密度、准确率、特异度,并利用SPSS 17.0统计软件对3种数据进行分析。结果雅培i2000SR系统灵敏度明显高于Addcare ELISA 600系统和手工法,Addcare ELISA 600系统灵敏度高于手工法,比较差异有统计学意义(P<0.05)。乙肝五项和丙肝抗体的标准物质手工操作、国产全自动酶免分析系统和雅培i2000SR系统的试验CV相互比较分别为14.5%>12.3%>2.1%、17.0%>12.5%>3.5%、10.8%>8.4%>3.0%、24.4%>19.6%>4.4%、20.0%>19.4%>2.0%、12.7%>11.1%>3.2%,手工操作法的CV大于国产全自动酶免分析系统的CV大于雅培i2000SR系统的CV,比较差异有统计学意义(P<0.05),3种方法对抗HBV和抗HCV试剂盒阳性、阴性参考品检测符合率为100.0%。3种方法对176份阴性标本的特异度均为100.0%。结论国产全自动酶免分析系统和雅培i2000SR系统与手工操作相比,重复性更好,且三者的诊断符合率、特异度均一致,国产全自动酶免分析系统可以替代手工操作用于临床常规标本检测。更多还原

【Abstract】 Objective To compare the differences in the detection of performance among the automatic enzyme-free analysis system and the imported enzyme-free analysis system and the manual method. Methods A total of 196 hepatitis B/C negative serum samples,20 hepatitis B positive serum samples,20 hepatitis C positive serum samples randomly collected in Hangzhou First People ’s Hospital in 2016. To compare the sensitivity,precision,accuracy and specificity of the three methods,we use 1 set of Zhuhai Lizhu company hepatitis B detection kit and a set of Beijing Kang Chester antiHBV national standard material,a set of Beijing million Thai hepatitis C kit and a set of Beijing Kang Chester anti-HCV national standard substances,respectively. Data were analyzed by SPSS 17. 0 software. Results Abbott i2000 SR system sensitivity was significantly higher than Addcare ELISA 600 system and manual method,Addcare ELISA 600 system sensitivity higher than manual method,the difference was statistically significant( P < 0. 05). The test CVs of the standard materials of the hepatitis B and the hepatitis C antibody were 14. 5% > 12. 3% > 2. 1%,17. 0% > 12. 5% > 3. 5%,10. 8% > 8. 4% > 3. 0%,24. 4% > 19. 6% > 4. 4%,20. 0% > 19. 4% > 2. 0%,12. 7% > 11. 1% > 3. 2%,respectively. The CV of the manual method is greater than that of the domestic automatic enzyme-free analysis system. The CV of the system is greater than that of the Abbott. The CV of the i2000 SR system was statistically significant( P < 0. 05).The coincidence rate of the three methods was 100. 0% for HBV and anti-HCV kit positive and negative reference. The specificity of the three methods was 100. 0% for 176 negative specimens. Conclusion The automatic enzyme-free analysis system and the Abbott i2000 SR system are more reproducible than manual operation,and the coincidence rate and specificity of the three are consistent. The domestic automatic enzyme-free analysis system can replace the manual operation Clinical routine specimen testing.更多还原