新型磁分离直接化学发光方法的建立及其临床应用

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Abstract Objective To establish a new direct chemiluminescence method for magnetic separation and explore the clinical application.Methods A new direct chemiluminescence method for magnetic separation was developed using isoluminol derivatives with high sensitivity as luminescent markers,immunomagnetic nanoparticles coated with goat anti-fluorescein isothiocyanate (FITC) polyclonal antibody with high specificity as separation reagents,NaOH and H2O2 as luminescent substrates.To evaluate the clinical application performance of this method,taking serum thyroid stimulating hormone (TSH) as an example,104 patients with hyperthyroidism who were newly diagnosed in Weihai Municipal Hospital from August 2019 to August 2020 were selected as hyperthyroidism group;121 patients with hypothyroidism were selected as hypothyroidism group;134 serum samples of healthy adults at the same period were taken as control group.The samples were detected by the method established in this study and ADVIA Centaur XP at the same time.The two results were compared to evaluate the clinical compliance.The sensitivity,precision and dilution recovery were evaluated by repeated detection of high,medium and low concentrations of standard solution.Results A new direct chemiluminescence method for magnetic separation was established.The sensitivity of the method was 0.01 μIU/mL.The intra and inter coefficient of variation (CV) was less than 5%,and the dilution recovery was more than 80%.The new direct chemiluminescence method for magnetic separation established in this study was compared with the direct chemiluminescence method of ADVIA Centaur XP for the TSH detection results,and the correlation coefficient was 0.9874.Conclusion A new magnetic separation direct chemiluminescence method has been successfully established,which has high sensitivity,high precision and good clinical compatibility,and has good clinical application value.

Key words： Thyroid stimulating hormone Trace active substances New direct chemiluminescence method for magnetic separation Quantitative detection

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	Articles by authors
	SONG Yu
	LIU Peng
	LI Wu
	YUAN Jin-yun
	CONG Hai-yan
	JU Yi
	YAO Ji-cheng
	WANG Ming-yi

Cite this article:

SONG Yu,LIU Peng,LI Wu, et al. Establishment of a new direct chemiluminescence method for magnetic separation and its clinical application[J]. 中国当代医药, 2020, 27(35): 8-11转15.

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https://www.dangdaiyiyao.com/EN/ OR https://www.dangdaiyiyao.com/EN/Y2020/V27/I35/8

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