2种方法检测血清中抗-HCV灰区结果分析

Analysis of the gray area results of two methods for detection of anti-HCV in serum

目的:对比分析酶联免疫吸附试验(ELISA)及化学发光微粒子免疫分析(CMIA)检测血清中丙肝抗体(抗?HCV)灰区结果,减少漏诊误诊。方法:运用CMIA和ELISA对系列稀释的质控血清进行检测,绘制浓度响应曲线,评估2种方法的灵敏度。分别用CMIA和ELISA检测A、B 2组灰区样本,分析2种方法筛查的灰区样本结果。此外,对B组样本检测HCV-RNA,并作分析。结果:CMIA法较ELISA法有更高的灵敏度(t=2.36,P<0.05);以ELISA法为对照组CMIA法为试验组检测A组灰区样本,2组阴阳性符合率为56.00%(42/75),2种方法差异有统计学意义(χ~2=14.67,P<0.01)。以CMIA法为对照组ELISA法为试验组检测B组灰区样本,2组总符合率为33.33%(10/33),差异有统计学意义(χ~2=17.39,P<0.01)。A组中ELISA法48.28%(28/58)的样本CMIA结果为无反应性;B组中CMIA法88.00%(22/25)的样本ELISA结果为无反应性,且其中27.27%(6/22)核酸检测为阳性。结论:CMIA的灰区设置为1.00~4.99,而ELISA的灰区设置为0.80~4.00,并对灰区范围的样本进行进一步复测,以有效减少假阳性率和漏诊率。

Objective：To compare CMIA method and ELISA method in the detection of anti HCV antibodies of the samples in gray area. And investigate the differences in practical application. Method：To repeat measurements on serial dilutions of control serum with CMIA and ELISA, draw the concentration response curve to assess the sensitivity of the two methods. Respectively to detect A and B groups of the gray- area samples with CMIA and ELISA, and analyze the two methods of screening grey area sample results. Furthermore, to analyze the B groups ＇results of HCV-RNA. Results：The CMIA is more sensitive than the ELISA（t=2.36,P〈0.05）; CMIA method for the control group by ELISA detection of the experimental group in group A, the accordance rate was 56.00% （42/75）, both methods have significant differences （2= 17.39, P〈0.01）;in group B, the accordance rate was 33.33%（10/33）, both methods have significant differences （2=14.67,P〈0.01）;48.28%（28/58） of theELISA weak reactions turn negtive with CMIA, and in the other way around, the rate was 80.00%（22/25）. 6 of this 22 samples were detected with PCR, and the results were postive. Conclusion：The gray area of CMIA is set to 1.00- 4.99,and the gray area of ELISA is set to 0.80-4.00. To further check and retest the samples of gray area can largely decrease the misdiagnosis and missed diagnosis rate.