温州地区献血者梅毒螺旋体抗体检测及召回分析

Detection and recall analysis of treponema pallidum antibody in blood donors in Wenzhou area

目的通过温州地区无偿献血者梅毒螺旋体抗体检测,对酶联免疫吸附试验(enzyme-linked immunosorbent assay,ELISA)单试剂反应性献血者开展召回自检及召回检测,评估召回方案的可行性。方法2021年1月至2023年5月成功参与无偿献血的献血者275652名,经抗梅毒螺旋体(treponema pallidum,TP)ELISA双试剂检测,对不同试剂检测反应性率、S/CO值等指标进行比较,同时选取ELISA检测单试剂反应性,且距上次献血屏蔽间隔6个月以上自愿参与召回的献血者24名,以面谈的方式进行召回告知,进行针对性的健康征询、一般检查和初筛检测合格后,采集血样进行召回自检和召回检测。结果抗TP ELISA试验共检测275652名,检出反应性数627例,反应性率为0.23%,其中双试剂反应性率为0.12%,单试剂反应性率为0.11%;双试剂反应性S/CO≥5.00占比73.6%(240/326),单试剂反应性S/CO<5.00占比92.4%(278/301);进入召回流程24名,成功召回20名,3名召回自检不合格,1人召回检测不合格,召回成功率83.3%(20/24)。结论采供血机构抗TP ELISA检测单试剂假反应性问题突出,通过建立的召回方案对召回意愿强烈的献血者进行召回自检和召回检测,既能保证献血者安全和血液质量,又能提升采供血服务体系建设水平。

Objective Through the detection of treponema pallida antibody in the unpaid blood donors in Wenzhou area,the recall self-test and recall test were carried out on the blood donors who were reactive to enzyme-linked immunosorbent assay(ELISA)test,and the feasibility of the recall plan was evaluated.Methods From January 2021 to May 2023,275652 blood donors who successfully participated in unpaid blood donation were tested by anti-treponema pallidum(TP)ELISA,the reactivity rate and S/CO value of different reagents were compared,and the reactivity of single reagent was detected by ELISA.In addition,24 blood donors who volunteered to participate in the recall more than six months after the last blood donation screening were informed of the recall by way of interview,targeted health consultation,general examination and preliminary screening test were passed,and blood samples were collected for recall self-test and recall test.Results A total of 275652 people were tested by anti-TP ELISA,and 627 cases were found to be reactive,with a reactivity rate of 0.23%,including a double reagent reactivity rate of 0.12%and a single reagent reactivity rate of 0.11%.The ratio of S/CO≥5.00 with double reagent was 73.6%(240/326),and the ratio of S/CO<5.00 with single reagent was 92.4%(278/301).24 people entered the recall process,20 people were successfully recalled,3 people failed to pass the self-test and 1 person failed to pass the test.The recall success rate was 83.3%(20/24).Conclusion The problem of false reactivity of anti-TP ELISA test single reagent in blood collection and supply institutions is prominent.Through the established recall scheme,the self-test and recall test of blood donors with strong recall intention can not only ensure the safety of blood donors,but also improve the construction of blood collection and supply service system.