Development and evaluation of a rapid and sensitive POC chemiluminescent assay for β-human chorionic gonadotropin
10.3969/j.issn.1000-484X.2024.03.029
- VernacularTitle: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
- Author:
Haiyu XIE
1
;
Jing QIN
;
Yanni ZHANG
;
Junjie LIU
;
Xiaowei HE
;
Yu WANG
Author Information
1. 华南理工大学食品科学与工程学院,广州 510641
- Keywords:
Human chorionic gonadotropin;
Chemiluminescence immunoassay;
Point-of-care testing;
Community health screening
- From:
Chinese Journal of Immunology
2024;40(3):615-620
- CountryChina
- Language:Chinese
-
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.
