Silvia Bérgamo , Jaume Trapé , Laura González-García , Carolina González-Fernández , Carme Vergara , Noelia de- la-Torre , Laia Bosch-Presegué , Marta Otero-Viñas , Silvia Catot , Manuel Crespo-Casal , Jose Rives-Jimenez , Anna Arnau , Roser Costa , José Ramón Cugat , Francesc Gonzalez-Sánchez , Xavier Pla-Salas , Francesc Sant
{"title":"HE4 在胸腔积液鉴别诊断中的诊断准确性。","authors":"Silvia Bérgamo , Jaume Trapé , Laura González-García , Carolina González-Fernández , Carme Vergara , Noelia de- la-Torre , Laia Bosch-Presegué , Marta Otero-Viñas , Silvia Catot , Manuel Crespo-Casal , Jose Rives-Jimenez , Anna Arnau , Roser Costa , José Ramón Cugat , Francesc Gonzalez-Sánchez , Xavier Pla-Salas , Francesc Sant","doi":"10.1016/j.cca.2024.120027","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Pleural effusions are challenging to diagnose, with approximately 20–50% of malignant effusions not diagnosed by cytology. Human epididymal protein 4 (HE4) may be useful in the differential diagnosis of pleural effusions. In serum, this biomarker shows false-positive results in some benign diseases. The aim of this study was to evaluate the diagnostic utility of HE4 in this setting and to identify false positives.</div></div><div><h3>Methods</h3><div>Concentrations of HE4, adenosine deaminase, % polynuclear cells, and C-reactive protein, were determined in 238 pleural fluid samples and the estimated glomerular filtration rate (eGFr) in serum.</div></div><div><h3>Results</h3><div>HE4 values differed significantly (p < 0.01) between malignant [median (IQR)] [1065 (2085)] pmol/L and benign effusions [699 (589)] pmol/L. HE4 concentrations in gynecological and pulmonary tumors were significantly higher than in other tumors.</div><div>For a cut-off point of 3050 pmol/L, 22 % sensitivity and 100 % specificity were obtained.</div><div>In patients with benign disease, significant increases in HE4 were identified only in those with eGFr < 30 mL/min/1.73 m<sup>2</sup> [1050(596)] pmol/L, and not in those with eGFr > 30 mL/min/1.73 m<sup>2</sup> [597(532)] pmol/L).</div><div>Two cut-offs were established for maximum specificity, depending on the eGFr: 3050 pmol/L for eGFr < 30 mL/min/1.73 m<sup>2</sup> and 1992 pmol/L for eGFr > 30 mL/min/1.73 m<sup>2</sup>. A sensitivity of 28.5 % was obtained for patients with eGFr > 30 mL/min/1.73 m<sup>2</sup> and 36.3 % for patients with eGFr < 30 mL/min/1.73 m<sup>2</sup>. The sensitivity using a specific cut-off point was 29.7 %.</div></div><div><h3>Conclusions</h3><div>The determination of HE4 in pleural fluids demonstrates high specificity and low sensitivity. The use of specific cutoff points that are clinically adjusted improves sensitivity while maintaining maximum specificity.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"566 ","pages":"Article 120027"},"PeriodicalIF":3.2000,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The diagnostic accuracy of HE4 in the differential diagnosis of pleural effusions\",\"authors\":\"Silvia Bérgamo , Jaume Trapé , Laura González-García , Carolina González-Fernández , Carme Vergara , Noelia de- la-Torre , Laia Bosch-Presegué , Marta Otero-Viñas , Silvia Catot , Manuel Crespo-Casal , Jose Rives-Jimenez , Anna Arnau , Roser Costa , José Ramón Cugat , Francesc Gonzalez-Sánchez , Xavier Pla-Salas , Francesc Sant\",\"doi\":\"10.1016/j.cca.2024.120027\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Pleural effusions are challenging to diagnose, with approximately 20–50% of malignant effusions not diagnosed by cytology. Human epididymal protein 4 (HE4) may be useful in the differential diagnosis of pleural effusions. In serum, this biomarker shows false-positive results in some benign diseases. The aim of this study was to evaluate the diagnostic utility of HE4 in this setting and to identify false positives.</div></div><div><h3>Methods</h3><div>Concentrations of HE4, adenosine deaminase, % polynuclear cells, and C-reactive protein, were determined in 238 pleural fluid samples and the estimated glomerular filtration rate (eGFr) in serum.</div></div><div><h3>Results</h3><div>HE4 values differed significantly (p < 0.01) between malignant [median (IQR)] [1065 (2085)] pmol/L and benign effusions [699 (589)] pmol/L. HE4 concentrations in gynecological and pulmonary tumors were significantly higher than in other tumors.</div><div>For a cut-off point of 3050 pmol/L, 22 % sensitivity and 100 % specificity were obtained.</div><div>In patients with benign disease, significant increases in HE4 were identified only in those with eGFr < 30 mL/min/1.73 m<sup>2</sup> [1050(596)] pmol/L, and not in those with eGFr > 30 mL/min/1.73 m<sup>2</sup> [597(532)] pmol/L).</div><div>Two cut-offs were established for maximum specificity, depending on the eGFr: 3050 pmol/L for eGFr < 30 mL/min/1.73 m<sup>2</sup> and 1992 pmol/L for eGFr > 30 mL/min/1.73 m<sup>2</sup>. A sensitivity of 28.5 % was obtained for patients with eGFr > 30 mL/min/1.73 m<sup>2</sup> and 36.3 % for patients with eGFr < 30 mL/min/1.73 m<sup>2</sup>. The sensitivity using a specific cut-off point was 29.7 %.</div></div><div><h3>Conclusions</h3><div>The determination of HE4 in pleural fluids demonstrates high specificity and low sensitivity. The use of specific cutoff points that are clinically adjusted improves sensitivity while maintaining maximum specificity.</div></div>\",\"PeriodicalId\":10205,\"journal\":{\"name\":\"Clinica Chimica Acta\",\"volume\":\"566 \",\"pages\":\"Article 120027\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2024-11-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinica Chimica Acta\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0009898124022800\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinica Chimica Acta","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0009898124022800","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
The diagnostic accuracy of HE4 in the differential diagnosis of pleural effusions
Background
Pleural effusions are challenging to diagnose, with approximately 20–50% of malignant effusions not diagnosed by cytology. Human epididymal protein 4 (HE4) may be useful in the differential diagnosis of pleural effusions. In serum, this biomarker shows false-positive results in some benign diseases. The aim of this study was to evaluate the diagnostic utility of HE4 in this setting and to identify false positives.
Methods
Concentrations of HE4, adenosine deaminase, % polynuclear cells, and C-reactive protein, were determined in 238 pleural fluid samples and the estimated glomerular filtration rate (eGFr) in serum.
Results
HE4 values differed significantly (p < 0.01) between malignant [median (IQR)] [1065 (2085)] pmol/L and benign effusions [699 (589)] pmol/L. HE4 concentrations in gynecological and pulmonary tumors were significantly higher than in other tumors.
For a cut-off point of 3050 pmol/L, 22 % sensitivity and 100 % specificity were obtained.
In patients with benign disease, significant increases in HE4 were identified only in those with eGFr < 30 mL/min/1.73 m2 [1050(596)] pmol/L, and not in those with eGFr > 30 mL/min/1.73 m2 [597(532)] pmol/L).
Two cut-offs were established for maximum specificity, depending on the eGFr: 3050 pmol/L for eGFr < 30 mL/min/1.73 m2 and 1992 pmol/L for eGFr > 30 mL/min/1.73 m2. A sensitivity of 28.5 % was obtained for patients with eGFr > 30 mL/min/1.73 m2 and 36.3 % for patients with eGFr < 30 mL/min/1.73 m2. The sensitivity using a specific cut-off point was 29.7 %.
Conclusions
The determination of HE4 in pleural fluids demonstrates high specificity and low sensitivity. The use of specific cutoff points that are clinically adjusted improves sensitivity while maintaining maximum specificity.
期刊介绍:
The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells.
The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.