Wolff Fleur, Gervy Christine, Gulbis Béatrice, Cotton Frédéric
a Department of Clinical Chemistry , LHUB-ULB, Erasme Hospital, Université Libre de Bruxelles , Brussels , Belgium.
Scand J Clin Lab Invest. 2017 Dec;77(8):689-693. doi: 10.1080/00365513.2017.1393693. Epub 2017 Oct 25.
Differences in human chorionic gonadotrophin (hCG) results provided by the commercial immunoassays reflect the heterogeneity of antibodies and the use of suboptimal standards. As a consequence, the principal forms of hCG and metabolites are differentially detected and the hCG tests are not suited for the same clinical applications. Conflicting results are available in the literature regarding which hCG variants are recognized by the Roche Elecsys hCG + β test. The aim of our study was to compare the hCG concentrations provided by the Siemens Immulite 2000 test and the Roche test as well as to assess the concordance between both assays.
In this purpose, 152 samples obtained from women and 44 samples from men were analysed by both tests during the follow-up of pregnancy termination, gestational trophoblastic disease and malignancies. The intermediate precision of the Roche test was also investigated on a pool with a low hCG concentration.
The hCG concentrations measured with the Roche test were slightly lower compared with the Siemens assay; mean biases of -34.2% and -8% were respectively obtained for hCG values ≤100 UI/L and higher than 100 UI/L. The overall agreement between both assays was 96.1% for women and 97.7% for men. By using an upper reference limit of 3.2 UI/L for women and 1.6 UI/L for men, the Roche test demonstrated a respective concordance of 98.7% and 100%. This test also yielded an excellent precision with a coefficient of variation of 2.8% at a mean hCG concentration of 7 UI/L.
商业免疫测定法所提供的人绒毛膜促性腺激素（hCG）检测结果存在差异，这反映了抗体的异质性以及次优标准的使用。因此，hCG的主要形式和代谢产物被不同程度地检测出来，并且hCG检测不适用于相同的临床应用。关于罗氏电化学发光免疫分析法（Roche Elecsys hCG + β test）能识别哪些hCG变体，文献中存在相互矛盾的结果。我们研究的目的是比较西门子免疫发光分析仪2000（Siemens Immulite 2000）检测法和罗氏检测法所提供的hCG浓度，并评估两种检测方法之间的一致性。
为此，在终止妊娠、妊娠滋养细胞疾病和恶性肿瘤的随访过程中，对152份女性样本和44份男性样本进行了两种检测。还在一个低hCG浓度的混合样本上研究了罗氏检测法的中间精密度。
与西门子检测法相比，罗氏检测法测得的hCG浓度略低；对于hCG值≤100 IU/L和高于100 IU/L的情况，平均偏差分别为-34.2%和-8%。两种检测方法对女性的总体一致性为96.1%，对男性为97.7%。通过使用女性3.2 IU/L和男性1.6 IU/L的参考上限，罗氏检测法的一致性分别为98.7%和100%。在平均hCG浓度为7 IU/L时，该检测法的变异系数为2.8%，精密度极佳。
