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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 the results of enzyme-linked immunosorbent assay (ELISA) and chemiluminescence microparticle immunoassay (CMIA) in detection of gray matter of anti-HCV in serum and reduce the misdiagnosis of misdiagnosis. Methods: Serial dilutions of quality control serum were detected by CMIA and ELISA, and the concentration response curve was drawn to evaluate the sensitivity of the two methods. The gray zone samples of A and B 2 groups were detected by CMIA and ELISA, respectively, and the gray zone samples of the two methods were analyzed. In addition, samples of group B were tested for HCV-RNA and analyzed. Results: The CMIA method was more sensitive than the ELISA method (t = 2.36, P <0.05). The CMIA method of the control group was used as the control group to test the gray zone samples of group A, the positive and negative rates of the two groups were 56.00% 42/75). There was a significant difference between the two methods (χ ~ 2 = 14.67, P <0.01). The CMIA method was used as the control group to test the gray zone samples of group B, the total coincidence rate was 33.33% (10/33) in group B, the difference was statistically significant (χ ~ 2 = 17.39, P <0.01). In group A, 48.28% (28/58) of the ELISA samples showed no response to CMIA, 88.00% (22/25) of CMIA showed no response in group B, and 27.27% (6/22 The nucleic acid test is positive. CONCLUSION: The gray zone of CMIA is set at 1.00-4.99, while the gray zone of ELISA is set at 0.80-4.00. Further tests are performed on the samples in the gray zone to effectively reduce the false positive rate and missed diagnosis rate.