β-人绒毛膜促性腺激素快速高灵敏化学发光POC检测方法的建立及评价
Development and evaluation of a rapid and sensitive POC chemiluminescent assay for β-human chorionic gonadotropin
谢海宇 1秦静 2张艳妮 1刘俊杰 1何小维 1王羽3
作者信息
- 1. 华南理工大学食品科学与工程学院,广州 510641
- 2. 广州万孚生物技术股份有限公司,广州 510670
- 3. 生物岛实验室(广州再生医学与健康广东省实验室),广州 510005
- 折叠
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0.710～1.092×104 mU/ml,且在1.7×105 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(R2=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.
Abstract
Objective:To develop and evaluate a rapid and sensitive point-of-care chemiluminescent assay(POC-CLIA)for β-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 of β-HCG was 0.71 mU/ml,linear detection range was 0.710～1.092×104 mU/ml,and was no hook effect up to 1.7×105 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 detecting β-HCG in 100 clinical serum samples,results were highly correlated with those that were tested by clinical standard methods(R2=0.997 0).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.
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Key words
Human chorionic gonadotropin/Chemiluminescence immunoassay/Point-of-care testing/Community health screening引用本文复制引用
基金项目
国家自然科学基金(82202582)
广东省即时检测(POCT)企业重点实验室项目(2021)(2021B1212050016)
广东省重点领域研发计划(2020B1111160004)
出版年
2024
国家科技期刊平台
NSTL
万方数据