献血者血液筛查HBsAg单试剂阳性结果分析  

Analysis on HBsAg reactive samples in blood donor screening, tested by one ELISA assay

作　　者：李素萍[1] 胡晓玉[1] 王婷婷 王恺 袁亮[1] 吕晴 张云[1] 王婷 程卫芳[1] LI Suping;HU Xiaoyu;WANG Tingting;WANG Kai;YUAN Liang;LV Qin;ZHANG Yun;WANG Ting;CHENG Weifang(Anhui Blood Center,Hefei 230031,China)

机构地区：[1]安徽省血液中心,安徽合肥230031

出　　处：《中国输血杂志》2020年第9期946-949,共4页Chinese Journal of Blood Transfusion

基　　金：合肥市卫健委2019年应用医学研究项目(hwj2019zd018)。

摘　　要：目的通过对献血者血液筛查HBsAg单试剂阳性标本核酸检测后电化学发光免疫分析法(ECLIA)补充乙肝五项,综合分析ELISA法HBsAg单试剂阳性献血者HBV DNA阳性/阴性标本ECLIA再次检测提高血液安全保障献血者权益的必要性。方法 2019年9月—2020年5月献血者血液标本91 847份,2种不同厂家ELISA HBsAg试剂检测,留取75份HBsAg单试剂阳性标本核酸检测后再用ECLIA补充血清学试验,定量检测HBsAg、抗-HBs、HBeAg、抗-HBe、抗-HBc。结果 75份HBsAg单试剂阳性标本核酸检测HBV DNA+ 15份,核酸定性筛查阳性率20%(15/75)。ECLIA检出HBsAg定量值(0.05-1) IU/mL标本9份,与ELISA阳性符合率12%(9/75)。15份HBsAg单试剂阳性HBV DNA+标本抗-HBc阳性率高达93.3%(14/15),抗-HBs定量均<10 U/L;60份HBsAg单试剂阳性HBV DNA-标本中抗-HBc阳性率达45%(27/60),检测出7种血清学模式,仅抗-HBs阳性,占33.33%(20/60),抗-HBs定量>100 IU/L 11份。结论 ELISA法检测HBsAg单试剂阳性标本补充ECLIA乙肝五项提高血液安全同时保障献血者权益。Objective To conduct supplemental ECLIA test for HBsAg reactive samples tested by one ELISA assay following NAT, in order to assist in determining the advisability of implementing ECLIA for HBV-NAT+/-samples implicated in HBsAg reactive samples tested by one assay.Methods 91 847 blood samples from September 2019 to May 2020 in our blood center were collected and screened by two ELISA HBsAg assays from different manufacturers. And 75 HBsAg reactive samples by one assay were subjected to supplemental serology test, ECLIA,.for quantative detection of HBsAg, anti-HBs, anti-HBe, HBeAg and anti-HBc. following nucleic acid testing(NAT).Results The HBV-NAT-yield rate implicated in HBsAg-ELISA-reactive samples tested with one assay was 20%(15/75). 9 samples, detected by ECLIA, presented viral load between 0.05 and 1 IU/mL, with the concordance rate of ECLIA and ELISA for HBsAg in 12%(9/75). 93.3%(14/15) of the 15 ELISA+/NAT+ samples had positive anti-HBc, and none had anti-HBs more than 10 IU/L;45%(27/60) of the 60 ELISA+/NAT-samples had positive anti-HBc, with 7 serological models detected out, and 33.33%(20/60)of them had anti-HBs as the sole positive marker, with anti-HBs>100 IU/L in 11 samples. Conclusion Supplemental testing as ECLIA to HBsAg reactvie samples tested with one ELISA assay could improve blood safety and protect the rights of blood donors.

关 键 词：献血者 血液筛查 乙肝表面抗原 电化学发光免疫分析法 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学]