四川地区供血浆者病毒指标筛查结果与确认试验的对比分析

Analysis of the results between screening and confirmation test in virus indicators of samples originated from plasma donors in Sichuan

目的通过比较ELISA法筛查供血浆者血浆HBs Ag、抗-HCV、抗-HIV结果和确认试验结果,分析不同检测值标本的确认阳性符合率。方法采用进口ELISA试剂,HBs Ag采用中和试验法进行确认、抗-HCV和抗-HIV采用重组免疫印迹法对ELISA筛查阳性标本208份进行确认,确认试验结果为不确定的标本采用NAT法检测,将2者结果进行对比分析。结果国产和进口ELISA试剂检测HBs Ag、抗-HCV、抗-HIV的确认阳性符合率分别为92.86%、94.74%和85.71%,3者比较差异无统计学意义(P>0.05)。结论对国产ELISA检测试剂用于供血浆者HBs Ag、抗-HCV、抗-HIV 3项检测的效果进行了科学评价,为假阳性供血浆者管理及ELISA检测试剂的选择提供了试验依据。

Objective To analyze the positive coincidence rate between ELISA and confirmation test in HBs Ag,antiHCV and anti-HIV by comparing the test results of samples originated from plasma donors with different test values. Methods208 positive samples screened by ELISA test using domestic ELISA kits were retested using imported ELISA kits. HBs Ag was confirmed by neutralization test; anti-HCV and anti-HIV were confirmed by recombinant immunoblot assay. The samples with uncertain confirmatory test results were tested by NAT method. The results of ELISA and confirmation test were compared and analyzed simultaneously. Results There were no statistically significant differences in the positive coincidence rates of HBs Ag,anti-HCV and anti-HIV between domestic and imported ELISA kits( P >0. 05). The positive coincidence rates of HBs Ag,anti-HCV and anti-HIV between ELISA and confirmation test were 92. 86%,94. 74% and 85. 71%,respectively.Conclusion Scientific evaluation was conducted on the domestic ELISA kit used in the test of HBs Ag,anti-HCV and antiHIV samples originated from plasma donors. Experimental evidence provided a basis for better management of plasma donors with false positive results and better selection of the kits used in ELISA testing.