基于胶体金免疫层析技术的乙肝和梅毒快速初筛效果评价及影响因素分析  

Evaluation and influencing factor analysis of the detection effect of hepatitis B virus surface antigen and treponema pallidum using rapid screening immunochromatography technology

作　　者：孙海英 范恩勇 焦玉东 许守广 沈楚铭 SUN Haiying;FAN Enyong;JIAO Yudong;XU Shouguang;SHEN Chuming(Yangzhou Blood Center,Yangzhou Blood Transfusion Research Institute,Yangzhou 225007,China)

机构地区：[1]扬州市中心血站扬州市输血研究所,江苏扬州225007

出　　处：《中国输血杂志》2023年第10期931-934,共4页Chinese Journal of Blood Transfusion

基　　金：江苏省卫生健康委员会指导性课题(Z2022060);扬州市重点研发项目(社会发展)(YZ2022085)。

摘　　要：目的 在献血者献血前利用胶体金免疫层析法HBsAg和抗-TP试剂快速初筛效果进行评价,并对影响因素进行探讨。方法 对2020年1月—2023年6月扬州地区献血人群献血前HBsAg、抗-TP项目初筛和献血后血液检测情况进行回顾性分析,并对2023年1月—2023年6月献血后血液检测ELISA法HBsAg、抗-TP反应性标本再次利用胶体金免疫层析法初筛试剂进行复检,对结果进行比对分析。结果 在200 414名献血前的初筛人群中,共筛查HBsAg、抗-TP不合格标本781份,占0.39%;共有191717名献血者成功献血,献血后ELISA法HBsAg、抗-TP血液检测不合格标本986份(0.51%);对62份ELISA法HBsAg和61份抗-TP反应性标本用初筛试剂再次进行复检,其中HBsAg复检反应性24份(38.71%),抗-TP复检反应性26份(42.62%),14份HBsAg和6份抗-TP灰区标本复检均无反应性,9份HBsAg检测S/CO>25.0和10份抗-TP检测S/CO>15.0的标本经胶体金试剂复检反应性率均为100%。反应性标本反应强度(S/CO值)与初筛反应性判读时间呈负相关。结论 在献血人群中开展胶体金免疫层析技术的乙肝和梅毒快速初筛项目,可有效提高血液质量和采集后血液合格率,通过有针对性地加强初筛工作人员的培训,可进一步提高初筛检测的质量,降低漏检率,节约成本,从而减少经血传播疾病感染的风险和保障献血者身体健康。Objective To evaluate the effectiveness of rapid initial screening using HBsAg and syphilis reagents of immunochromatography technology before blood donation,and explore the influencing factors.Methods The pre-donation screening of HBsAg and anti-TP and post-donation blood test results of blood donors in Yangzhou region from January 2020 to June 2023 were retrospectively analyzed.The HBsAg and anti-TP reactive samples by ELISA from January to June 2023 were,retested using colloidal gold immunochromatographic reagents,and the results were compared and analyzed.Results A total of 200414 blood donors were screened,among which 781 were HBsAg and anti-TP positive,accounting for 0.39%.A total of 191717 blood donors successfully donated blood,and 986 were HBsAg and anti-TP positive by ELISA,accounting for 0.51%.62 HBsAg and 61 anti-TP reactive samples were retested using the initial screening reagent,with 24 HBsAg reactive samples and 26 anti-TP reactive samples,accounting for 38.71%and 42.62%respectively.14 HBsAg and 6 anti-TP gray area samples were retested,but no reactivity was found.The reactivity rates of 9 samples with HBsAg detection S/CO values greater than 25.0 and 10 samples with anti-TP detection S/CO values greater than 15.0 were all 100%.There was a negative correlation between the reaction intensity(S/CO value)of reactive samples and interpretation time of initial screening reaction.Conclusion The rapid primary screening of hepatitis B and syphilis with immunochromatography technology among blood donors can effectively improve the quality of blood and the qualification rate of blood after collection.Through targeted training of primary screening staff,the quality of primary screening can be further improved,the rate of missed detection can be reduced,and costs can be saved,thus reducing the risk of transfusion transmitted infection and ensuring the health of blood donors.

关 键 词：免疫层析技术 乙型肝炎病毒表面抗原 梅毒螺旋体抗体 快速初筛 

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