Objective To evaluate the clinical performance of the HSCL5000 high-sensitive chemiluminescence immunoassay system in hormone detection,and to further compare the results with ci16200 and Centaur XP detection systems.Methods Under the same experimental conditions,the high-and low-value specimens of each hormone were detected repeatedly by different detection systems 4 times for 5 consecutive days,and the detection imprecision of each detection system was calculated and compared;Different detection systems were used to detect the hormones samples covering the detection range as far as possible,and the results consistency of different detection systems was evaluated;The high-value traceable standard products and the gradient diluted samples of each hormone were detected repeatedly by HSCL5000 test system,and the correlation between the test mean and the theoretical value was calculated;Repeated detection of the high and low value of each hormone traceable standard were performed by HSCL5000 detection system,and the bias between the mean value of the detection results and the target values was calculated.Results The imprecision of HSCL5000 detection system for each hormone was within the allowable range of capability verification,and the imprecision of follicle stimulating hormone(FSH),testosterone(T)and prolactin(PRL)was better than that of Centaur XP,while the imprecision of human chorionic gonadotropin(hCG)and progesterone(P)low value specimens was better than ci16200;Both hCG and P results in HSCL5000 and ci16200 detection systems and estradiol(E2),FSH,LH,T,PRL results in HSCL5000 and Centaur XP detection systems showed a good consistency(r＞0.975);HSCL5000 test system had a good correlation between the mean value and the theoretical value of each hormone standard(r＞0.975);The bias between the mean value and the target value of the HSCL5000 test system for the standard product was within±0.15.Conclusion HSCL5000 hypersensitive chemiluminescence immunoassay system is able to pass the clinical performance verification in hormone detection,and the detection results show a good consistency with ci16200 and Centaur XP detection system,which indicates good application values in the real-world clinical practice.
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