献血者HTLV的初筛检测及确证试验的初步研究  

Screening and confirmatory test of HTLV in blood donors,apreliminary study

作　　者：欧山海 谢金镇 庄淑程 林永财 裴斌 宋秀宇 OU Shanhai;XIE Jinzhen;ZHUANG Shucheng;Lin Yongcai;PEI Bin;SONG Xiuyu(Xiamen Blood Center,Xiamen 361004,China)

机构地区：[1]厦门市中心血站,福建厦门361004

出　　处：《中国输血杂志》2021年第2期158-161,共4页Chinese Journal of Blood Transfusion

基　　金：福建省卫生计生中青年骨干人才培养项目(2016-ZQN-93);厦门市医疗卫生科技计划项目(3502Z20194100)。

摘　　要：目的对献血者中人类嗜T淋巴细胞病毒的初筛检测及确证试验进行初步研究。方法对福建省9地市血站2016~2018年无偿献血者标本进行抗-HTLV-1/2筛查,抗-HTLV-1/2阳性者留取血浆标本统一送至厦门市中心血站进行确证试验,分析不同初筛检测试剂及不同确证试验方法对检测结果的影响。结果共收集了抗-HTLV-1/2初筛阳性741例,经蛋白印迹试验确证阳性252例、不确定15例、阴性474例,总体确证阳性率为34.0%(252/741)。在不同地区,国产A试剂的确证阳性率存在明显差别(宁德最高73.9%(88/119),漳州最低仅4.0%(4/99);在同一地区(福州市),不同的抗-HTLV-1/2初筛检测试剂的确证阳性率比较,国产A试剂为33.3%(13/39),进口B试剂为57.1%(56/98),差异具有统计学意义(c^(2)=26.93,P<0.01);S/CO值>5时,国产A试剂确证阳性率76.5%(13/17)明显低于进口B试剂100%(56/56)(c^(2)=9.77,P<0.01);共有652例抗-HTLV-1/2初筛阳性标本同时进行了蛋白免疫印迹与核酸检测2种确证试验,其中638例结果相符、14例结果不一致,总体符合率97.85%。结论不同的HTLV抗体初筛试剂的确证阳性率存在差异;蛋白免疫印迹与核酸检测2种确证试验的总体符合率较高,但也存在一定的互补性。Objective To study the screening and confirmatory test of human T-lymphotropic virus(HTLV) in blood donors. Methods Anti HTLV-1/2 screening was conducted on voluntary blood donors from 9 cities in Fujian province betweenJan. 12016 toDec. 312018.Plasma samples ofanti-HTLV-1/2 reactive donors werecollected and sent to Xiamen Blood Center for confirmatory test. The influence of different screening reagents and confirmatory test methods on the test results were analyzed.Results A total of 741 anti-HTLV-1/2 reactivesamples were collected, among which 252 were positiveby Western Blot, 15 undetermined,and 474 negative, withthe overall positive rate at 34.0%(252/741).The yielding rate of domestic reagent A was significantly differentbyregions, withthe highest in Ningde(73.9%,88/119) and the lowest in Zhangzhou(4.0%,4/99).The confirmedpositive rates of anti-HTLV-1/2 screening reagent A(domestic) and B(imported)were 33.3%(13/39) and 57.1%(56/98),respectively, and the difference was statistically significant(P<0.01).When S/CO >5, the reagent Ayielding rate was 76.5%(13/17), significantly lower than that of imported reagent Bas 100%(56/56)(P<0.01). A total of 652 anti-HTLV-1/2 reactive samples were confirmed by Western Blot and nucleic acid test in parallel, among which 638 results were concordant, 14 were not, with the overall concordance rate at 97.85%.Conclusion Comparable differences in the yielding rate of twoanti-HTLV screening reagents were observed.There was over allhighconcordance,but also complementarity,between Western Blot and nucleic acid test.

关 键 词：人类嗜T淋巴细胞病毒 确证试验 血液筛查 

分 类 号：R446.11[医药卫生—诊断学]