摘要
目的:建立β-人绒毛膜促性腺激素(β-HCG)快速高灵敏化学发光POC检测法(POC-CLIA)并进行评价。方法:采用碱性磷酸酶(Alp)-AMPPD发光体系,以磁微粒(Mps)为固相载体构建POC-CLIA,并评估其灵敏度、精密度、准确度、线性范围、特异性、稳定性、钩状效应和临床应用。结果:β-HCG最低检测限为0.71 mU/ml,线性检测范围为0.710~1.092×10^(4) mU/ml,且在1.7×10^(5) mU/ml内无钩状效应影响。批内和批间变异系数均<10%,可在37℃稳定保存10 d。准确度偏差在±10%之内,结果可靠。干扰物质与β-HCG均无交叉反应。对100例临床血清标本进行检测,与临床标准方法检测结果高度相关(R^(2)=0.997 0)。单个样品检测时间<15 min,且测试通量可达到200 T/h。结论:该方法具有较高应用价值,可广泛用于基层社区,助力基层医疗中妊娠及相关疾病筛查。
Objective:To develop and evaluate a rapid and sensitive point-of-care chemiluminescent assay(POC-CLIA)forβ-human chorionic gonadotropin(β-HCG).Methods:POC-CLIA was constructed based on alkaline phosphatase(Alp)-AMPPD lumi-nescence system and magnetic particles(Mps)carrier.Performance of POC-CLIA,including sensitivity,precision,accuracy,linear dilution,specificity,stability,hook effect and clinical application were evaluated.Results:Detection limit ofβ-HCG was 0.71 mU/ml,linear detection range was 0.710~1.092×10^(4) mU/ml,and was no hook effect up to 1.7×10^(5) mU/ml.Intra and inter batch coefficients of variation were less than 10%,and could be stored stably at 37℃for 10 days.Accuracy deviation was within±10%,so results were reliable.There was no cross-reactivity between interfering substances and anti-β-HCG antibdies.For detectingβ-HCG in 100 clinical serum samples,results were highly correlated with those that were tested by clinical standard methods(R^(2)=0.9970).Turnaround time for single sample was less than 15 min and throughput could reach 200 T/h.Conclusion:This method is adequate that can be widely used in grassroots communities to help large-scale screening of pregnancy and related diseases.
作者
谢海宇
秦静
张艳妮
刘俊杰
何小维
王羽
XIE Haiyu;QIN Jing;ZHANG Yanni;LIU Junjie;HE Xiaowei;WANG Yu(South China University of Tech-nology,Guangzhou 510461,China;Guangzhou Wondfo Biotech Co.,LTD.,Guangzhou 510670,China;Bio-land Laboratory,Guangzhou Regenerative Medicine and Health Guangdong Laboratory,Guangzhou 510005,China)
出处
《中国免疫学杂志》
CAS
CSCD
北大核心
2024年第3期615-620,共6页
Chinese Journal of Immunology
基金
国家自然科学基金(82202582)
广东省即时检测(POCT)企业重点实验室(2021年度)项目(2021B1212050016)
广东省重点领域研发计划项目(2020B1111160004)。
关键词
人绒毛膜促性腺激素
化学发光免疫
即时检测
基层健康筛查
Human chorionic gonadotropin
Chemiluminescence immunoassay
Point-of-care testing
Community health screening
