摘要
目的通过对比开展＂1遍ELISA＋1遍NAT血液筛查＂新模式前后HBsAg、抗-HCV和抗-HIV的反应性比率,比较新旧2种筛查方法检测结果的符合率,探讨新模式的应用效果。方法 2013年1月1日～6月13日青岛市中心血站采用2遍ELISA 1遍NAT筛查了42 147例标本,6月14日～12月31日采用1遍ELISA 1遍NAT筛查了55 924例标本,比较采用新模式前后HBsAg、抗-HCV和抗-HIV的反应性比率,分析新模式中反应性标本在ELISA和NAT中的符合率。结果 1遍ELISA的HBsAg和抗-HCV反应性比率与2遍相比较,差异无显著统计学意义（P〉0.05）;而抗-HIV的反应性比率明显低于2遍ELISA模式,差异有统计学意义（P〈0.05）,抗-HIV的假阳性率为75%。采用1遍ELISA共检测出HBsAg、抗-HCV和抗-HIV ELISA反应性标本217例,3者的强反应性标本（OD=3.0）在2种检测方法的符合率分别为93.94%、95.24%、100%,在HBsAg ELISA弱反应性标本中,2方法的符合率随S/CO值的增大而增高（0%～90%）,灰区标本未检出核酸阳性,而抗-HCV和抗-HIV的弱反应性标本（OD〈3.0）的符合率均为0%。结论减掉1遍ELISA对HBsAg和抗-HCV的反应性比率没有明显的影响,而显著降低了抗-HIV的反应性比率,处于强阳性水平时,ELISA方法的检测结果与NAT符合率较高;ELISA弱反应性标本中2方法的符合率较低,减掉1遍ELISA对检测试剂和人员均提出了更高的要求。
Objective To compare, the reactivity ratio of HBsAg, anti-HCV and anti-HIV before and after reduction of the previous two parallel serological tests into one;and to calculate the coincidence rate between the methods of ELISA and NAT to explore the effect of applying the new model. Methods From January 1 2013 to June 13 2013 using NAT combined with two parallel serologic tests we screened 42 147 donations ;while from June 14th to December 3lst using NAT combined with one serologic test we screened 55 924 specimens in Qingdao blood center. We compared the reactivity ratio of HBsAg, anti-HCV and anti-HIV before and after the changing of screening models, and calculated the coincidence rate of reactive samples between the methods of ELISA and NAT in new mode. Results There was no Significant difference between two par- allel serologic tests and one serologic testing in reactivity ratio of HBsAg and anti HCV （ P 〉0. 05） and the reactivity ratio of anti-HIV were signifieandy lower than that of NAT combined With two parallel serologic tests （ P 〈 0. 05 ）. The false positive rate of anti2HIV was 75%. We detected atotal of 217 ELISA reactive specimens,the coincidence rate of ELISA and NAT in strong reactive samples （OD = 3.0） were 93.94% （HBV） ,95.24%, （ HCV ）, and 100% （ HIV ）, respectively. The coinci- dence rate （0% r-90% ） increased along with the value of S/CO in HBsAg ELISA weak reactive samples. NAT positive sam- pie was not found in ELI.SA gray zone samples. Coincidence rate of anti-HCV and anti-HIV in weak reactive samples （ OD 〈 3.0） was 0%. Conclusion Reducing the previous two＇ parallel serologic tests into one has no obvious influence on reactivity ratio of HBsAg and anti-HCV, but decreases the reactivity ratio of anti-HIV significantly. Coincidence rate Of ELISA and NAT is high in strong reactive samples,but lown Weakreactive sampleS. The reduction of one round ELISA test puts forward to higher requirements ofreagents and personnel.
出处
《中国输血杂志》
CAS
CSCD
北大核心
2014年第9期920-922,共3页
Chinese Journal of Blood Transfusion
基金
卫生部部署(管)医疗机构临床学科重点项目建设专项基金(201002005)
