Bérgamo Silvia, Trapé Jaume, González-García Laura, González-Fernández Carolina, Vergara Carme, de-la-Torre Noelia, Trujillo Glòria, Estivill Dolors, Álvarez-González Marco Antonio, Bosch Laia, Otero-Viñas Marta, Bergós Carmen, Catot Silvia, Ruiz-Hidalgo Domingo, Ros Sandra, Sant Francesc
Department of Laboratory Medicine, Althaia Xarxa Assistencial Universitària Manresa, Manresa, Catalonia, Spain; Tissue Repair and Regeneration Laboratory (TR2Lab), Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IrisCC), 08500 Vic, Barcelona, Spain; Doctoral School, University of Vic - Central University of Catalonia (UVic-UCC), Vic., Catalonia, Spain.
Department of Laboratory Medicine, Althaia Xarxa Assistencial Universitària Manresa, Manresa, Catalonia, Spain; Tissue Repair and Regeneration Laboratory (TR2Lab), Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IrisCC), 08500 Vic, Barcelona, Spain; Faculty of Medicine, University of Vic - Central University of Catalonia, Vic, Catalonia, Spain.
Clin Biochem. 2023 Oct;120:110645. doi: 10.1016/j.clinbiochem.2023.110645. Epub 2023 Sep 9.
Human epididymal protein 4 (HE4) may be a useful tool in the differential diagnosis of malignant ascites. The aim of this study was to evaluate the diagnostic utility of HE4 for detecting malignant ascites, taking into account the possible false positives identified with adenosine deaminase (ADA), C-reactive protein (CRP), % polynuclear cells (%PMN) and glomerular filtration rate (eGFR).
Concentrations of HE4, ADA, %PMN and CRP were determined in 114 samples of peritoneal fluid and creatinine in serum in order to calculate eGFR.
Concentrations of HE4 presented significant differences (P = 0.028) in benign [median (interquartile range)] [582(372)] pmol/L) and malignant ascites ([8241(367)] pmol/L. Sensitivity was 21.2% and specificity 100%. Significant differences were also observed for HE4 between tumors of gynecological origin ([3165(8769)] pmol/L) and others ([665(663)] pmol/L), with a sensitivity of 67% and a specificity of 100%. Classifying according to possible false positives (ADA > 45U/L, CRP > 50 mg/L, %PMN > 90 and eGFR < 30 mL/min/1.73 m) at maximum specificity, a sensitivity of 33.3% was obtained for HE4, with a cut-off point of 2660 pmol/L. Without possible false positives (ADA < 45U/L, CRP < 50 mg/L, %PMN < 90 and eGFR ≥ 30 mL/min/1.73 m), a sensitivity of 37.7% was obtained at 100% specificity for a cut-off point of 1041 pmol/L. Applying these criteria to the entire group, a sensitivity of 36.4% was obtained at maximum specificity.
HE4 allows the identification of malignant ascites with moderate sensitivity at maximum specificity. HE4 levels can differentiate between tumors of gynecological origin and others. Classification according to possible false positives increases sensitivity without losing specificity.
人附睾蛋白4（HE4）可能是鉴别诊断恶性腹水的有用工具。本研究的目的是评估HE4在检测恶性腹水中的诊断效用，同时考虑腺苷脱氨酶（ADA）、C反应蛋白（CRP）、多形核细胞百分比（%PMN）和肾小球滤过率（eGFR）可能出现的假阳性情况。
测定了114份腹水样本中HE4、ADA、%PMN和CRP的浓度以及血清中的肌酐浓度，以计算eGFR。
HE4浓度在良性腹水[中位数（四分位间距）][582（372）]pmol/L）和恶性腹水中[8241（367）]pmol/L）存在显著差异（P = 0.028）。敏感性为21.2%，特异性为100%。在妇科来源肿瘤[3165（8769）]pmol/L）和其他肿瘤[665（663）]pmol/L）之间，HE4也存在显著差异，敏感性为67%，特异性为100%。根据最大特异性时可能的假阳性情况（ADA > 45U/L、CRP > 50mg/L、%PMN > 90且eGFR < 30mL/min/1.73m²）进行分类，HE4的敏感性为33.3%，截断点为2660pmol/L。在不存在可能的假阳性情况（ADA < 45U/L、CRP < 50mg/L、%PMN < 90且eGFR ≥ 30mL/min/1.73m²）时，截断点为1041pmol/L，特异性为100%时敏感性为37.7%。将这些标准应用于整个组，在最大特异性时敏感性为36.4%。
HE4在最大特异性时能以中等敏感性识别恶性腹水。HE4水平可区分妇科来源肿瘤和其他肿瘤。根据可能的假阳性情况进行分类可提高敏感性且不损失特异性。
