Berger P, Sturgeon C
Head, Endocrinology Department, Institute for Biomedical Aging Research, Austrian Academy of Sciences, Rennweg 10, A6020 Innsbruck, Austria +43 512 583919 24 ; +43 512 583919 8 ;
Expert Opin Med Diagn. 2008 Dec;2(12):1347-64. doi: 10.1517/17530050802558907.
Clinical management of pregnancy, pregnancy-related disorders and trophoblastic tumors is dependent on immunoassay measurements of the complex analyte human chorionic gonadotropin (hCG). Differences in hCG results using different methods affect clinical interpretation with potentially adverse consequences for patient care. Objectives/method: To provide an overview of factors contributing to method-related differences in hCG measurements and how to overcome these drawbacks.
RESULTS/CONCLUSION: Six recently established highly purified and molar unit calibrated World Health Organization Reference Reagents for important hCG variants provide means for in-depth characterization of diagnostic immunoassays for hCG. For different clinical applications in pregnancy and cancer, appropriate epitopes and specificities of pairs of monoclonal antibodies against hCG in immunoassays have been clearly defined. This led to the conclusion that in routine clinical situations assays are preferred that measure all relevant hCG variants. The adoption of new nomenclature unambiguously describing what is being measured and the anticipated introduction of a new highly pure international standard for hCG represent significant progress towards improved analytical reliability and comparability of diagnostic hCG results.
妊娠、妊娠相关疾病及滋养层细胞瘤的临床管理依赖于对复合分析物人绒毛膜促性腺激素（hCG）的免疫测定。使用不同方法得出的hCG结果差异会影响临床解读，对患者护理可能产生不良后果。目的/方法：概述导致hCG测量中方法相关差异的因素以及如何克服这些缺点。
结果/结论：六种最近建立的针对重要hCG变体的高度纯化且经摩尔单位校准的世界卫生组织参考试剂，为深入表征hCG诊断免疫测定提供了手段。对于妊娠和癌症中的不同临床应用，免疫测定中针对hCG的单克隆抗体对的适当表位和特异性已得到明确界定。由此得出结论，在常规临床情况下，优选能检测所有相关hCG变体的检测方法。采用明确描述所测物质的新命名法以及预期引入新的高纯度hCG国际标准，代表着在提高诊断hCG结果的分析可靠性和可比性方面取得了重大进展。
