The differential diagnostic value of serum HE4 in ovarian disease with elevated CA125; importance of diagnostic added va

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The differential diagnostic value of serum HE4 in ovarian disease with elevated CA125; importance of diagnostic added value in clinical practice Siamak Sabour1,2  Received: 27 April 2020 / Accepted: 4 July 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020

Abstract For clinical purposes, diagnostic added value of HE4 is important. Diagnostic knowledge is not provided by answering the question, “How accurate is this test?” (test accuracy research). Diagnostic knowledge is the information needed to answer the question, “What is the probability of the presence or absence of a specific disease given these test results?” (diagnostic accuracy research). Therefore, diagnostic added value of HE4 expression (differences of ROC curves for two diagnostic models with and without HE4) is important in clinical practice. Without assessing reliability, we cannot judge about diagnostic value. The diagnostic value is estimated by two parameters: reliability and accuracy. Keyword  CA125 · Differential diagnosis · HE4 · Ovarian disease · Diagnostic added value I was interested in reading the paper by Li w. and colleagues that was published in the May 2020 edition of the Arch Gynecol Obstet [1]. The authors aimed to determine the  diagnostic value  and clinical significance of serum HE4 levels in differentiating between benign and malignant ovarian disease in patients with elevated CA125 levels. The levels and positive expression rate of HE4 were compared between 371 patients with elevated CA125 levels and benign ovarian disease, and 132 patients with epithelial ovarian cancer to determine the diagnostic value of HE4. They mentioned the level and positive expression rate of HE4 differed significantly between the benign and malignant groups, in that, there was no significant difference in HE4 expression between CA125 low- and high-level groups within the benign ovarian disease group, with levels of HE4 being in the normal range in both groups. However, the positive expression rates and levels of HE4 in the malignant * Siamak Sabour [email protected] 1



Department of Clinical Epidemiology, School of Health and Safety, Shahid Beheshti University of Medical Sciences, Chamran Highway, Velenjak, Daneshjoo Blvd, Tehran 198353‑5511, Islamic Republic of Iran



Safety Promotions and Injury Prevention Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic of Iran

2

group were significantly different between the serum CA125 low- and high-level groups. ROC curve analysis showed that optimal HE4 cutoff values for increased accuracy in diagnosis were 78.03 pmol/L and 119.70 pmol/L before and after menopause, respectively. Though the article provides insight into the decision that serum HE4 levels can potentially be used as a marker to differentiate between benign and malignant ovarian disease with elevated serum CA125 levels, its conclusion is limited in two ways. First, it is good to know that knowledge of the reported estimates do not give total information about importance