Guan Xiaoyong, Sun Yifan, Zhang Hongyu, Liang Ka, Long Kang, Li Jin, Tang Shifu, Liu Chunming
Clin Lab. 2016 Sep 1;62(9):1815-1820. doi: 10.7754/Clin.Lab.2016.160225.
Human chorionic gonadotropin-beta (β-hCG) is an important index used to monitor embryonic development following embryo transfer. Architect i2000sr and Cobas e601 are widely used automated immunoassay systems used to measure serum β-hCG concentrations; however, the correlations between serum β-hCG levels measured with these two immunoassays and the accuracy of the immunoassays have not been fully evaluated.
Serum β-hCG levels were measured in 133 serum samples using the Architect i2000sr and Cobas e601 automated immunoassay systems. Passing-Bablok regression analysis was used to compare the correlation in serum β-hCG levels obtained using the two immunoassays. A Bland-Altman plot analysis was used to identify mean ratios and 95% CIs of the mean ratios of the β-hCG results between the two immunoassays. In this graphical method the mean ratios between the two techniques were plotted against the averages of the two techniques.
The total coefficients of variations (CVs) of serum β-hCG ranged from 3.12 - 4.66% for Cobas e601 and 3.18 - 4.99% for Architect i2000sr. The measured value of serum β-hCG detected by the two immunoassays was statistically significant (p < 0.001). The Passing-Bablok regression analysis showed good correlation between the serum β-hCG values measured using the two systems. At a low concentration of serum β-hCG (< 10000 IU/L, n = 52), the correlation coefficient r was 0.9628. At a high concentration of serum β-hCG (> 10000 IU/L, n = 81), the correlation coefficient r was 0.8076. The Bland-Altman plot analysis showed that the measured value of serum β-hCG detected by Architect i2000sr was about 1.25 times higher than that of Cobas e601. The mean ratio was 1.12 at a low concentration of serum β-hCG, and it was 1.33 at a high concentration.
Architect i2000sr and Cobas e601 have good concordance for determining serum β-hCG. However, the β-hCG values measured with Architect i2000sr were 25% higher than those obtained using Cobas e601.
人绒毛膜促性腺激素β（β-hCG）是胚胎移植后监测胚胎发育的重要指标。Architect i2000sr和Cobas e601是广泛用于测量血清β-hCG浓度的自动化免疫分析系统；然而，这两种免疫分析方法所测血清β-hCG水平之间的相关性以及免疫分析的准确性尚未得到充分评估。
使用Architect i2000sr和Cobas e601自动化免疫分析系统对133份血清样本进行血清β-hCG水平检测。采用Passing-Bablok回归分析比较两种免疫分析方法所测血清β-hCG水平的相关性。使用Bland-Altman图分析确定两种免疫分析方法β-hCG结果的平均比值及95%可信区间。在这种图形方法中，将两种技术之间的平均比值与两种技术的平均值进行绘图。
Cobas e601血清β-hCG的总变异系数（CV）范围为3.12 - 4.66%，Architect i2000sr为3.18 - 4.99%。两种免疫分析方法所测血清β-hCG值具有统计学意义（p < 0.001）。Passing-Bablok回归分析表明，两种系统所测血清β-hCG值之间具有良好的相关性。在血清β-hCG低浓度（< 10000 IU/L，n = 52）时，相关系数r为0.9628。在血清β-hCG高浓度（> 10000 IU/L，n = 81）时，相关系数r为0.8076。Bland-Altman图分析表明，Architect i2000sr所测血清β-hCG值比Cobas e601高约1.25倍。在血清β-hCG低浓度时平均比值为1.12，高浓度时为1.33。
Architect i2000sr和Cobas e601在测定血清β-hCG方面具有良好的一致性。然而，Architect i2000sr所测β-hCG值比使用Cobas e601所测值高25%。
