CA-125 glycovariant assays enhance diagnostic sensitivity in the detection of epithelial ovarian cancer.

IF 3.7 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Stefanos Moukas, Katri Kuningas, Marjut Helle, Leena Kokko, Rainer Kimmig, Sabine Kasimir-Bauer, Paul Buderath, Kaisa Huhtinen
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Abstract

Objectives: Ovarian cancer is the deadliest gynaecologic malignancy. Due to the lack of reliable biomarkers for the detection of the early disease, most patients are diagnosed at an advanced stage resulting in poor survival. We therefore aimed at establishing novel CA-125 glycovariant assays to improve the diagnostic sensitivity and specificity of ovarian cancer.

Methods: Blood samples of 184 patients with epithelial ovarian cancers (EOC), 127 benign ovarian tumors, and 115 healthy controls were measured using GLYVAR™ Ovarian I and II assays (Uniogen) and the conventional CA-125 protein assay (CanAg CA-125 EIA, Fujirebio).

Results: The two glycovariant assays differentiated benign and malignant ovarian masses with 88.0 % sensitivity at 99 % specificity, whereas CA-125 showed 72.8 % sensitivity. The improved performance was most evident in patients with borderline or moderately elevated CA-125 concentration at diagnosis, which is a challenging group for differential diagnostics. The CA-125 glycovariant assays showed 2.5 times higher sensitivity (33.3 % with CA-125 vs. 83.3 % with the CA-125 glycovariants) at 94 % specificity. CA-125 glycovariants corrected 82.4 % of false positive results given by CA-125 concentrations with the commonly used cutoff 35 U/mL. Importantly, the CA-125 glycovariant assays detected 63.6 % of early-stage serous carcinomas from benign and healthy controls with very high 99 % specificity, while CA-125 had a sensitivity of only 45.5 %, representing a 40 % increase.

Conclusions: This is the first study describing the clinical performance of GLYVAR Ovarian I and II assays in ovarian cancer diagnostics. The results indicate that the CA-125 glycovariant assays have remarkable potential to improve ovarian cancer diagnostics.

CA-125糖变分析提高了上皮性卵巢癌的诊断敏感性。
目的:卵巢癌是最致命的妇科恶性肿瘤。由于缺乏可靠的生物标志物来检测早期疾病,大多数患者被诊断为晚期,导致生存率低。因此,我们旨在建立新的CA-125糖变检测方法,以提高卵巢癌的诊断敏感性和特异性。方法:对184例上皮性卵巢癌(EOC)患者、127例良性卵巢肿瘤患者和115名健康对照患者的血液样本进行检测,采用GLYVAR™ovarian I和II检测(Uniogen)和常规CA-125蛋白检测(CanAg CA-125 EIA, Fujirebio)。结果:两种糖变法鉴别卵巢良恶性肿块的敏感性为88.0 %,特异性为99 %,而CA-125的敏感性为72.8 %。在诊断时CA-125浓度处于临界或中度升高的患者中,性能的改善最为明显,这是鉴别诊断的一个具有挑战性的群体。CA-125糖变体检测显示灵敏度高2.5倍(CA-125为33.3% %,CA-125糖变体为83.3 %),特异性为94% %。CA-125糖变异体纠正了CA-125浓度给出的82.4 %的假阳性结果,通常使用的截止值为35 U/mL。重要的是,CA-125糖变法检测良性和健康对照中63.6 %的早期浆液性癌,特异性高达99 %,而CA-125的敏感性仅为45.5% %,增加了40 %。结论:这是第一个描述GLYVAR卵巢I和II检测在卵巢癌诊断中的临床表现的研究。结果表明,CA-125糖变分析有显著的潜力,以提高卵巢癌的诊断。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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