Utility of commonly used commercial human chorionic gonadotropin immunoassays in the diagnosis and management of trophoblastic diseases.
Utility of commonly used commercial human chorionic gonadotropin immunoassays in the diagnosis and management of trophoblastic diseases.
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DOI：
10.1093/clinchem/47.2.308
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发表时间：
2001-02
影响因子：
9.3
通讯作者：
L. Cole;S. Shahabi;S. Butler;H. Mitchell;E. Newlands;H. Behrman;H. Verrill
中科院分区：
文献类型：
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作者：
L. Cole;S. Shahabi;S. Butler;H. Mitchell;E. Newlands;H. Behrman;H. Verrill
背景滋养细胞疾病患者产生普通和不规则形式的人绒毛膜促性腺激素（hCG;例如，缺口hCG、缺失β亚基C-末端片段的hCG、高糖基化hCG和游离β亚基），其通过自动免疫计量hCG（或hCG β）测定以不同程度识别。这导致低或假阴性结果和误诊的持续性疾病。还检测到hCG免疫反应性假阳性，导致滋养层疾病的不必要治疗。在这里，我们比较了七种常用的hCG检测方法。方法采用5种不规则型hCG的标准品，对59例确诊的滋养细胞疾病患者血清和12例既往hCG假阳性的妇女血清进行检测（主要在Abbott AxSYM测定中）由商业实验室在Beckman Access hCG β、Abbott AxSYM hCG β、Chiron ACS：180 hCG β、巴克斯特Stratus hCG试验、DPC Immulite hCG试验、Serono MAIA克隆hCG β试验和hCG β RIA。结果5种不规则hCG标准品中，只有RIA和DPC能准确检出。在确诊滋养细胞疾病的患者中，只有Beckman、DPC和Abbott检测的结果与RIA相似（59例患者中分别有49、49和54例的值在RIA的25%范围内）。对于先前发现产生假阳性hCG结果的样本，在Beckman（1/5）、Serono（2/9）和巴克斯特（1/5）测定中，DPC和Chiron试验（5份样本，中位数10 IU/L）以及hCG β RIA（3/9;所有测定的中位数<5 IU/L）中未检测到假阳性结果。这些样本在Abbott AxSYM检测试剂盒早期产生假阳性结果，在重新评估时继续产生高值（中位数，81 IU/L）。结论：在六种常用的hCG免疫测定法中，只有DPC检测到β hCG的五种不规则形式，与RIA一致，并避免了测试样品中的假阳性结果。这种检测方法，以及类似设计的检测方法，在这里没有测试，似乎适合在滋养细胞疾病的诊断和管理的hCG测试。
BACKGROUND Patients with trophoblastic diseases produce ordinary and irregular forms of human chorionic gonadotropin (hCG; e.g., nicked hCG, hCG missing the beta-subunit C-terminal segment, hyperglycosylated hCG, and free beta subunit) that are recognized to differing extents by automated immunometric hCG (or hCG beta) assays. This has led to low or false-negative results and misdiagnosis of persistent disease. False-positive hCG immunoreactivity has also been detected, leading to needless therapy for trophoblastic diseases. Here we compare seven commonly used hCG assays. METHODS Standards for five irregular forms hCG produced in trophoblastic diseases, serum samples from 59 patients with confirmed trophoblastic diseases, and serum samples from 12 women with previous false-positive hCG results (primarily in the Abbott AxSYM assay) were blindly tested by commercial laboratories in the Beckman Access hCG beta, the Abbott AxSYM hCG beta, the Chiron ACS:180 hCG beta, the Baxter Stratus hCG test, the DPC Immulite hCG test, the Serono MAIAclone hCG beta tests, and in the hCG beta RIA. RESULTS Only the RIA and the DPC appropriately detected the five irregular hCG standards. Only the Beckman, DPC, and Abbott assays gave results similar to the RIA in the patients with confirmed trophoblastic diseases (values within 25% of RIA in 49, 49, and 54 of 59 patients, respectively). For samples that were previously found to produce false-positive hCG results, no false-positive results were detected with the DPC and Chiron tests (5 samples, median 10 IU/L) in the Beckman (1 of 5), Serono (2 of 9), and Baxter assays (1 of 5), and the hCG beta RIA (3 of 9; median for all assays, <5 IU/L). These samples, which produced false-positive results earlier in the Abbott AxSYM assay, continued to produce high values upon reassessment (median, 81 IU/L). CONCLUSIONS Of six frequently used hCG immunometric assays, only the DPC detected the five irregular forms of beta hCG, agreed with the RIA, and avoided false-positive results in the samples tested. This assay, and similarly designed assays not tested here, seem appropriate for hCG testing in the diagnosis and management of trophoblastic diseases.