Engell Anna Elise, Carlsson Elin Rebecka, Jørgensen Finn Stener, Sørensen Steen
Department of Clinical Biochemistry, Copenhagen University Hospital Hvidovre, Denmark.
Fetal Medicine Unit, Department of Obstetrics and Gynaecology, Copenhagen University Hospital Hvidovre, Denmark.
Pract Lab Med. 2017 Jul 11;9:18-23. doi: 10.1016/j.plabm.2017.07.001. eCollection 2017 Dec.
The biochemical serum markers free β-human chorionic gonadotropin (hCGβ) and pregnancy associated plasma protein A (PAPP-A), used in screening for trisomy 21 (T21), trisomy 18 (T18), and trisomy 13 (T13) during the first trimester, can be measured on different laboratory instruments e.g. Kryptor (Brahms) and Cobas (Roche). We compared the performance of these two analytical instruments when used for first trimester combined testing.
Serum samples from 944 singleton pregnant women attending for first trimester combined testing were routinely assayed for hCGβ and PAPP-A on Kryptor, and re-analyzed on Cobas. In addition, serum samples from 70 pregnant women carrying a fetus affected by T21, T18 or T13, were re-assayed on Cobas.
For the screening population, the hCGβ and PAPP-A results in multiples of the median (MoM) from Kryptor and Cobas were significantly lower on Cobas when compared to Kryptor. The number of pregnant women with a risk above 1:300 for T21 was 48 for both Cobas and Kryptor, although a few patients only had a high risk with one of the methods. Overall, the screen positive rate was 5.1% for both instruments. In the trisomy groups the calculated risks for T21, T18, and T13 agreed well between Cobas and Kryptor.
The screen positive rate for T21 (5.1%) did not differ between the two analytical platforms in our screening population, although PAPP-A measurements form Cobas were significantly lower than those from Kryptor. The calculated risks for the pregnancies affected by trisomies using hCGβ MoM and PAPP-A MoM from Kryptor agreed well with those from Cobas.
用于孕早期21三体（T21）、18三体（T18）和13三体（T13）筛查的生化血清标志物游离β-人绒毛膜促性腺激素（hCGβ）和妊娠相关血浆蛋白A（PAPP-A），可在不同的实验室仪器上进行检测，例如Kryptor（勃林格）和Cobas（罗氏）。我们比较了这两种分析仪器用于孕早期联合检测时的性能。
对944例前来进行孕早期联合检测的单胎孕妇的血清样本，常规在Kryptor上检测hCGβ和PAPP-A，并在Cobas上重新分析。此外，对70例怀有T21、T18或T13胎儿的孕妇的血清样本，在Cobas上重新检测。
对于筛查人群，与Kryptor相比，Cobas上hCGβ和PAPP-A的中位数倍数（MoM）结果显著更低。Cobas和Kryptor检测出T21风险高于1:300的孕妇人数均为48例，不过少数患者仅在其中一种检测方法中显示高风险。总体而言，两种仪器的筛查阳性率均为5.1%。在三体组中，Cobas和Kryptor计算出的T21、T18和T13风险结果吻合良好。
在我们的筛查人群中，两种分析平台的T21筛查阳性率（5.1%）无差异，尽管Cobas检测的PAPP-A值显著低于Kryptor检测的。使用Kryptor的hCGβ MoM和PAPP-A MoM计算出的三体妊娠风险与Cobas计算出的结果吻合良好。
