摘要
目的通过调查国内不同地区临床实验室血人绒毛膜促性腺激素(hCG)参考区间的应用现状,为规范hCG参考区间的设置和应用提供依据。方法于2022年5月至6月期间,采用问卷星平台网络问卷方式,向国内不同省市的医疗机构临床实验室发放调查问卷进行研究。调查的内容包括:实验室相关信息,hCG检测仪器品牌型号、试剂品牌,参考区间设置是否区分性别、绝经前后、妊娠周期,参考区间来源、是否经过验证和征求临床意见以及检验报告中是否注明检测系统等。收集问卷数据结果进行统计分析。结果共回收有效问卷102份。其中三级医院91份,二级医院11份,包括综合医院69份,妇幼保健院13份,其他专科医院、中医院及中西医结合医院14份。82.4%的实验室使用一套检测系统,17.6%的实验室则使用了不同品牌或相同品牌不同型号的2套检测系统,所有实验室均使用仪器配套检测试剂。64家(62.8%)实验室仅设置单一的参考区间,未设置绝经后、妊娠周期相关及男性参考区间。23家(22.6%)实验室提供了绝经后参考区间,29家(28.4%)实验室提供了男性参考区间,41家(40.2%)实验室提供了基于妊娠周期的参考区间。共有14家(13.7%)实验室同时提供基于性别、妊娠周期和绝经前后的参考区间。绝经前非妊娠女性hCG参考区间占比前三的是:<5 IU/L(43.1%)、<5.3 IU/L(13.7%)和<3 IU/L(9.8%)。87.3%的参考区间来自厂商说明书,52.9%的实验室对参考区间进行了验证,50%的实验室在检验报告中说明了检测系统。使用相同检测系统的实验室,引用的厂商说明书参考区间的也存在显著差异。结论多数临床实验室未根据性别、绝经前后、妊娠周期设置hCG参考区间,不同实验室hCG参考区间差异大,有必要进行规范。
Objective To investigate the application status of the reference interval of human chorionic gonadotropin(hCG)in clinical laboratories across different regions nationwide,and provide a basis for standardizing its setting and application.Methods By using the online questionnaire method on the Questionnaire Star platform,we distributed the questionnaires to clinical laboratories of medical institutions in different provinces and cities across the country for the research from May to June 2022.The contents of the survey included:laboratory⁃related information,brand and model of hCG testing instruments,reagent manufactures,whether the reference interval setting stratified by gender,pre⁃and post⁃menopause,pregnancy cycle,and the source of reference interval,the validation and clinical consultation were sought,and whether the testing system was specified in report.The results of questionnaire data were collected for statistical analysis.Results A total of 102 valid questionnaires were recovered.Among them,91 were from tertiary hospitals and 11 were from secondary hospitals,including 69 general hospitals,13 maternal and child health care hospitals,and 14 other specialized hospitals,traditional Chinese medicine hospitals,and integrated traditional Chinese and Western medicine hospitals.A total of 82.4%of the laboratories used one set of testing systems,while 17.6%used two sets of testing systems of different brands or the same brand with different modes.All laboratories used instrument⁃matched reagents.64(62.8%)laboratories set only a single reference interval,without separate reference intervals for postmenopausal women,pregnancy cycle⁃related stages,and male reference intervals.A total of 23(22.6%)laboratories provided postmenopausal reference interval,29(28.4%)provided male reference interval,and 41(40.2%)provided reference interval based on the gestational cycle.Overall,14(13.7%)laboratories provided the reference interval stratified by gender,pregnancy cycle,and menopausal status.The three most common hCG reference intervals for pre⁃menopausal non⁃pregnant women were:<5 IU/L(43.1%),<5.3 IU/L(13.7%),and<3 IU/L(9.8%).87.3%of the reference intervals were sourced from the manufacturer’s instructions.52.9%of the laboratories verified the reference interval.50%of the laboratories reportted the testing system in the report.Even among the laboratories using the same testing system,significant differences existed in the reference intervals provided from the manufacturer’s documentation.Conclusion Most domestic clinical laboratories have not set the hCG reference interval stratified by gender,pre⁃and post⁃menopause,and pregnancy cycle,resulting significant inter⁃laboratories varition for the hCG reference intervals that necessitates standardization.
作者
朱旭
侯立安
张颖
刘荔
夏良裕
邱玲
ZHU Xu;HOU Li’an;ZHANG Ying;LIU LI;XIA Liangyu;QIU Ling(Department of Clinical Laboratory,Peking Union Medical College Hospital,Peking Union Medical College&Chinese Academy of Medical Science,Beijing 100730,China)
出处
《临床检验杂志》
2026年第2期138-142,共5页
Chinese Journal of Clinical Laboratory Science
基金
中央高水平医院临床科研专项(2022⁃PUMCH⁃B⁃073)。
关键词
人绒毛膜促性腺激素
参考区间
问卷调查
human chorionic gonadotropin
reference interval
questionnaire survey
