Arch Gynecol Obstet. 2012 Feb;285(2):553-5. doi: 10.1007/s00404-011-2108-2. Epub 2011 Oct 13.
Non-invasive first trimester screening for fetal aneuploidy is based on the consideration of fetal nuchal translucency, biochemical serum markers 'pregnancy associated plasma protein A' (PAPP-A), and 'free beta-humane chorionic gonadotropin' (fβ-hCG). The blood sera of 168 pregnant women in 11 + 0 to 13 + 6 weeks of gestation were examined by both the COBAS (Roche Holding GmbH, Germany) and KRYPTOR (Brahms GmbH, Germany) immunoassay systems in two quality controlled laboratories. The concentration values were converted into multiple of median (MoM) values and compared through a two-tailed t test. The concentration values of PAPP-A differed significantly from each other (p < 0.0001). COBAS produced on average 0.09 MoM higher values in comparison to KRYPTOR (CI 95% = 0.06-0.11 MoM). In contrast, the concentration values of fβ-hCG did not differ significantly (p value = 0.20). The values produced by COBAS were on average only 0.02 MoM higher in comparison to KRYPTOR (CI 95% = -0.01 to 0.05 MoM). Which of the two systems generates the more precise results should be evaluated in a large-scale prospective study with the pregnancy outcomes.
用于胎儿非整倍体无创性早孕期筛查的方法是基于胎儿颈项透明层（NT）、生化血清标志物妊娠相关血浆蛋白 A（PAPP-A）和游离人绒毛膜促性腺激素-β亚基（fβ-hCG）的考虑。在两个质量控制实验室中，使用 COBAS（罗氏诊断公司，德国）和 KRYPTOR（BRAHMS 公司，德国）免疫测定系统对 168 名 11+0 至 13+6 孕周的孕妇的血样进行了检测。浓度值被转换为中位数倍数（MoM）值，并通过双尾 t 检验进行比较。PAPP-A 的浓度值差异有统计学意义（p < 0.0001）。与 KRYPTOR 相比，COBAS 平均产生高 0.09 MoM 的值（95%CI = 0.06-0.11 MoM）。相比之下，fβ-hCG 的浓度值差异无统计学意义（p 值= 0.20）。COBAS 与 KRYPTOR 相比，其浓度值仅平均高 0.02 MoM（95%CI = -0.01 至 0.05 MoM）。应该在一项大型前瞻性研究中，根据妊娠结局评估这两种系统中哪一种产生更精确的结果。
