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ORIGINAL ARTICLE  原创文章

The first pediatric study investigating the utility of a noninvasive urine-based test for acute pancreatitis diagnosis
第一项儿科研究，调查无创尿液检测对急性胰腺炎诊断的效用

Tamar Orgad 1 1 ^(1){ }^{\mathbf{1}} | Isra Abu-Rahma 1 1 ^(1){ }^{\mathbf{1}} | David Rekhtman 2 2 ^(2){ }^{\mathbf{2}} | Saar Hashavya 2 2 ^(2){ }^{\mathbf{2}} | Peri Milman 1 1 ^(1){ }^{\mathbf{1}} | Mordechai Slae 1 1 ^(1){ }^{\mathbf{1}} | Zev Davidovics 1 1 ^(1){ }^{\mathbf{1}} | Michael Wilschanski 1 1 ^(1){ }^{\mathbf{1}} | Liron Birimberg-Schwartz 1 1 ^(1){ }^{\mathbf{1}} (D)
塔玛·奥加德 1 1 ^(1){ }^{\mathbf{1}} |伊斯拉·阿布-拉赫马 1 1 ^(1){ }^{\mathbf{1}} |大卫·雷克特曼 2 2 ^(2){ }^{\mathbf{2}} |萨尔·哈沙维亚 2 2 ^(2){ }^{\mathbf{2}} |佩里·米尔曼 1 1 ^(1){ }^{\mathbf{1}} |莫迪凯·斯莱 1 1 ^(1){ }^{\mathbf{1}} |泽夫·达维多维奇 1 1 ^(1){ }^{\mathbf{1}} |迈克尔·威尔尚斯基 1 1 ^(1){ }^{\mathbf{1}} |利隆·比林伯格-施瓦茨 1 1 ^(1){ }^{\mathbf{1}} （D）

1 1 ^(1){ }^{1} Department of Pediatric Gastroenterology, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel
1 1 ^(1){ }^{1} 以色列耶路撒冷希伯来大学 Hadassah 医学中心和医学院儿科胃肠病学系
2 2 ^(2){ }^{2} Department of Pediatric Emergency Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel
2 2 ^(2){ }^{2} 以色列耶路撒冷希伯来大学 Hadassah 医疗中心儿科急诊医学科

Correspondence  通信

Liron Birimberg-Schwartz.
利隆·比林伯格-施瓦茨。
Email: Ibschwartz@hadassah.org.il
电子邮件： Ibschwartz@hadassah.org.il
Funding information  资金信息
None  没有

Abstract  抽象

Objectives: Pediatric acute pancreatitis (AP) is a growing clinical concern with a wide spectrum of severity, from mild episodes to life-threatening conditions. Traditional diagnostic methods primarily rely on serum amylase and lipase measurements, which are invasive and can be challenging in children. This study is the first to evaluate the diagnostic accuracy of the urine trypsinogen-2 dipstick test (UTDT) as a noninvasive test for diagnosing pediatric AP. Methods: This prospective study included 28 pediatric patients (31 episodes) presenting with acute abdominal pain at a tertiary medical center from November 2022 to October 2024. AP was diagnosed based on the International Study Group of Pediatric Pancreatitis: In Search for a Cure (INSPPIRE) criteria. Urine samples were collected either within the first 24 hours ( h h hh ) or later during hospitalization. UTDT sensitivity and specificity were calculated and compared to serum amylase and lipase levels. Results: Of the 31 episodes, 19 (61%) were confirmed as AP, and 12 (39%) were attributed to other causes. The UTDT had an overall sensitivity of 68 % 68 % 68%68 \% and specificity of 100 % 100 % 100%100 \%. Sensitivity increased to 87 % 87 % 87%87 \% when urine samples were collected within 24 h of admission. In non-AP cases, UTDT consistently produced negative results, with the high specificity supporting its reliability in distinguishing AP from other conditions. Conclusions: The UTDT demonstrates promise as a rapid, noninvasive diagnostic tool for pediatric AP, particularly when used early in the disease course. Its high specificity and ease of use suggest that it may serve as an alternative to invasive blood tests once validated through larger-scale studies. Further research is needed to confirm these findings and establish the role of UTDT in clinical practice.
目的： 小儿急性胰腺炎 （AP） 是一个日益严重的临床问题，严重程度范围很广，从轻微发作到危及生命的疾病。传统的诊断方法主要依赖于血清淀粉酶和脂肪酶的测量，这些测量是侵入性的，对儿童来说可能具有挑战性。本研究首次评估了尿胰蛋白酶原 2 试纸试验 （UTDT） 作为诊断儿科 AP 的无创检测的诊断准确性。方法： 这项前瞻性研究包括 2022 年 11 月至 2024 年 10 月在三级医疗中心就诊的 28 名儿科患者 （31 次发作）。AP 是根据国际小儿胰腺炎研究组：寻找治愈 （INSPPIRE） 标准诊断的。在住院后的最初 24 小时内 （ h h hh ） 或之后收集尿样。计算 UTDT 敏感性和特异性，并与血清淀粉酶和脂肪酶水平进行比较。结果： 在 31 次发作中，19 次 （61%） 被确认为 AP，12 次 （39%） 归因于其他原因。UTDT 的总体敏感性 68 % 68 % 68%68 \% 和特异性为 100 % 100 % 100%100 \% 。入院后 24 小时内收集尿样 87 % 87 % 87%87 \% 时，敏感性增加。在非 AP 病例中，UTDT 始终产生阴性结果，高特异性支持其区分 AP 与其他情况的可靠性。结论： UTDT 有望作为一种快速、无创的儿科 AP 诊断工具，尤其是在病程早期使用时。其高特异性和易用性表明，一旦通过更大规模的研究验证，它可以作为侵入性血液检测的替代方案。 需要进一步的研究来证实这些发现并确定 UTDT 在临床实践中的作用。

KEYWORDS  关键字
diagnostic utility, pediatric acute pancreatitis, urine trypsinogen-2 dipstick test
诊断效用、小儿急性胰腺炎、尿胰蛋白酶原-2 试纸试验

1 | INTRODUCTION  1 |介绍

Pediatric acute pancreatitis (AP) is a significant and increasingly recognized condition characterized by inflammation of the pancreas. The clinical spectrum of AP ranges from mild, self-limiting episodes to severe, life-threatening disease that can result in multiple organ dysfunction. 1 , 2 1 , 2 ^(1,2){ }^{1,2} Although less common in children than in adults, the incidence of pediatric AP has risen steadily over the past two decades, making it an emerging concern in pediatric medicine. 3 − 6 3 − 6 ^(3-6){ }^{3-6}
小儿急性胰腺炎 （AP） 是一种重要且越来越被认可的疾病，其特征是胰腺炎症。AP 的临床范围从轻度、自限性发作到可导致多器官功能障碍的严重、危及生命的疾病。 1 , 2 1 , 2 ^(1,2){ }^{1,2} 虽然儿童 AP 的发病率不如成人少，但在过去二十年中，儿科 AP 的发病率稳步上升，使其成为儿科医学中新兴的问题。 3 − 6 3 − 6 ^(3-6){ }^{3-6}
Classically, AP presents with severe upper abdominal pain radiating to the back, often accompanied by vomiting. However, its clinical presentation in children can sometimes be atypical, overlapping with other acute abdominal conditions, which can delay diagnosis. Timely assessment in the emergency setting, including measurement of serum amylase and lipase levels, is crucial for diagnosis.
典型情况下，AP 表现为严重的上腹痛放射至背部，通常伴有呕吐。然而，它在儿童中的临床表现有时可能是不典型的，与其他急性腹部疾病重叠，这可能会延迟诊断。在紧急情况下及时评估，包括测量血清淀粉酶和脂肪酶水平，对诊断至关重要。
According to the International Study Group of Pediatric Pancreatitis: In Search for a Cure (INSPPIRE), the diagnosis of AP requires meeting at least two of three criteria: (i) abdominal pain consistent with AP, (ii) serum amylase or lipase levels at least three times the upper limit of normal, and (iii) imaging findings indicative of AP. 7 7 ^(7){ }^{7} While this definition provides a practical framework for clinical diagnosis, it necessitates hospital-based evaluation and lacks a universally accepted biological marker as a “gold standard.”
根据国际小儿胰腺炎研究组：寻找治愈 （INSPPIRE），AP 的诊断需要满足以下三个标准中的至少两个：（i） 与 AP 一致的腹痛，（ii） 血清淀粉酶或脂肪酶水平至少是正常上限的三倍，以及 （iii） 指示 AP 的影像学检查结果。 7 7 ^(7){ }^{7} 虽然该定义为临床诊断提供了实用框架， 它需要以医院为基础的评估，并且缺乏普遍接受的生物标志物作为“金标准”。
In recent years, efforts have been made to identify alternative diagnostic methods that eliminate the need for invasive blood tests. One such tool is the urine trypsinogen-2 dipstick test (UTDT), which has demonstrated good diagnostic accuracy
近年来，人们一直在努力寻找无需侵入性血液检测的替代诊断方法。尿胰蛋白酶原 2 试纸检测 （UTDT） 就是这样一种工具，它已被证明具有良好的诊断准确性

What is Known?  什么是已知的？

  • Pediatric acute pancreatitis (AP) incidence has increased significantly in recent decades.
    近几十年来，小儿急性胰腺炎 （AP） 的发病率显著增加。
  • Diagnosis of pediatric AP is based on clinical presentation, elevated serum pancreatic enzymes, and imaging findings.
    儿科 AP 的诊断基于临床表现、血清胰酶升高和影像学检查结果。
  • The urinary trypsinogen-2 dipstick test (UTDT) has demonstrated high sensitivity and specificity for diagnosing AP in adults, but pediatric data are lacking.
    尿胰蛋白酶原 2 试纸试验 （UTDT） 已证明诊断成人 AP 具有很高的敏感性和特异性，但缺乏儿科数据。

What is New?  什么是新功能？

  • UTDT is a sensitive and specific tool for diagnosing pediatric AP.
    UTDT 是一种用于诊断儿科 AP 的敏感且特异的工具。
  • Sensitivity improves significantly when performed early in the disease course.
    在病程早期进行时，敏感性显著提高。
  • UTDT provides a noninvasive alternative to blood tests, reducing discomfort for children.
    UTDT 提供了一种无创的血液检测替代方案，可减轻儿童的不适。
  • The test enhances diagnostic accuracy by distinguishing AP from other causes of abdominal pain.
    该测试通过区分 AP 和其他原因引起的腹痛来提高诊断准确性。
    for AP in adults. 8 , 9 8 , 9 ^(8,9){ }^{8,9} However, its effectiveness and applicability in pediatric populations have yet to be evaluated.
    针对成人 AP。 8 , 9 8 , 9 ^(8,9){ }^{8,9} 然而，其在儿科人群中的有效性和适用性尚未得到评估。
This study aims to evaluate the diagnostic accuracy of the UTDT in pediatric AP by comparing its performance to standard serum amylase and lipase tests. By exploring the potential of UTDT as a rapid, noninvasive diagnostic tool, we seek to address an important gap in the diagnosis and management of pediatric AP.
本研究旨在通过将 UTDT 的性能与标准血清淀粉酶和脂肪酶检测进行比较，评估 UTDT 在儿科 AP 中的诊断准确性。通过探索 UTDT 作为快速、无创诊断工具的潜力，我们寻求解决儿科 AP 诊断和管理中的重要差距。

2 | METHODS  2 |方法

2.1 | Study design
2.1 |研究设计

This prospective study included 28 pediatric patients presenting with acute abdominal pain who were admitted to the pediatric emergency department (ED) at Hadassah University Medical Center between November 2022 and October 2024. Some patients presented to the ED on multiple occasions, resulting in a total of 31 reported cases.
这项前瞻性研究包括 2022 年 11 月至 2024 年 10 月期间在哈达萨大学医学中心儿科急诊科 （ED） 收治的 28 名患有急性腹痛的儿科患者。一些患者多次到急诊科就诊，共报告了 31 例病例。

2.2 | Ethics statement
2.2 |道德声明

Written informed consent was obtained from all participants or their legal guardians, and the study was approved by the institutional ethics committee (approval number HMO-0018-22).
已获得所有参与者或其法定监护人的书面知情同意书，并且该研究得到了机构伦理委员会的批准（批准号 HMO-0018-22）。

2.3 | Inclusion criteria
2.3 |纳入标准

Children aged 0-19 years admitted to the ED with complaints of pain in the upper or central abdomen or vomiting, without suspicion of acute gastroenteritis, were eligible for inclusion. The study also included children with a history of chronic pancreatitis or recurrent pancreatitis. Patients with a history of chronic abdominal pain or a primary complaint of diarrhea or constipation were excluded.
因主诉上腹部或中央腹部疼痛或呕吐而未怀疑急性胃肠炎的 0-19 岁儿童符合纳入条件。该研究还包括有慢性胰腺炎或复发性胰腺炎病史的儿童。有慢性腹痛病史或原发性主诉腹泻或便秘的患者被排除在外。
The diagnosis of AP was based on criteria defined by the INSPPIRE consortium, as outlined in the introduction. 7 7 ^(7){ }^{7}
AP 的诊断基于 INSPPIRE 联盟定义的标准，如引言中所述。 7 7 ^(7){ }^{7}

2.4 | Data collection
2.4 |数据采集

For each participant, data collected included demographic information, vital signs, and findings on physical exam. A detailed medical history was recorded, capturing information on underlying diseases, previous episodes of AP, and any history of chronic pancreatitis. Laboratory findings were documented, encompassing liver enzyme levels, kidney function tests, C-reactive protein (CRP), and pancreatic enzyme measurements, along with the results of imaging studies.
对于每个参与者，收集的数据包括人口统计信息、生命体征和体格检查结果。记录详细的病史，收集有关潜在疾病、AP 既往发作和任何慢性胰腺炎病史的信息。记录了实验室检查结果，包括肝酶水平、肾功能检查、C 反应蛋白 （CRP） 和胰酶测量，以及影像学研究的结果。
Serum amylase and lipase levels were obtained for all patients upon admission to the ED. For most patients, a second blood test was performed on the same day as urine collection. However, in some cases, urine samples were collected later during hospitalization due to technical limitations.
所有患者在入院急诊时均获得血清淀粉酶和脂肪酶水平。对于大多数患者，在收集尿液的同一天进行了第二次血液检查。然而，在某些情况下，由于技术限制，在住院期间晚些时候收集尿液样本。
Imaging studies were performed as part of the diagnostic workup, with most patients undergoing abdominal ultrasound. Abdominal computed tomography (CT) scans were conducted when clinically necessary.
影像学检查作为诊断性检查的一部分进行，大多数患者接受腹部超声检查。临床需要时进行腹部计算机断层扫描 （CT）。
All collected data were anonymized and coded to ensure confidentiality.
所有收集的数据都经过匿名和编码以确保机密性。

2.5 | UTDT  2.5 |UTDT

Urine trypsinogen-2 levels were measured using the Actim ® ® ^(®){ }^{\circledR} Pancreatitis urine test (Medix Biochemica). This immunochromatographic assay employs monoclonal anti-trypsinogen-2 antibodies, with a detection limit of 50 μ g / L 50 μ g / L 50 mug//L50 \mu \mathrm{~g} / \mathrm{L}.
使用 Actim ® ® ^(®){ }^{\circledR} 胰腺炎尿液试验 （Medix Biochemica） 测量尿胰蛋白酶原 2 水平。该免疫层析检测采用单克隆抗胰蛋白酶原-2 抗体，检测限为 50 μ g / L 50 μ g / L 50 mug//L50 \mu \mathrm{~g} / \mathrm{L} 。
The test procedure involved immersing the strip in a urine sample for 20 seconds, removing it, and allowing it to rest at room temperature for 5 min . Results were interpreted based on the appearance of stripes: two blue stripes (a test stripe and a control stripe) indicated elevated trypsinogen-2 levels ( > 50 μ g / L > 50 μ g / L > 50 mug//L>50 \mu \mathrm{~g} / \mathrm{L} ), a single blue stripe (control stripe only) signified normal trypsinogen-2 levels, and the absence of both stripes rendered the test invalid, requiring repetition. The presence of the control stripe validated the reliability of the test. The test kits were provided as a gift to the research team by the manufacturer for the purposes of this study.
测试程序包括将试纸浸入尿液样本中 20 秒，将其取出，并使其在室温下静置 5 分钟。根据条纹的外观对结果进行解释：两条蓝色条纹（一条测试条和一条对照条）表示胰蛋白酶原 2 水平升高 （ > 50 μ g / L > 50 μ g / L > 50 mug//L>50 \mu \mathrm{~g} / \mathrm{L} ），一条蓝色条纹（仅对照条）表示胰蛋白酶原 2 水平正常，两条条纹的缺失使测试无效，需要重复。控制条的存在验证了测试的可靠性。检测试剂盒是制造商作为礼物提供给研究团队的，用于本研究。

2.6 | Statistical analysis
2.6 |统计分析

The sensitivity and specificity of the diagnostic tests were calculated along with 95% confidence intervals using the MedCalc Software Ltd. Diagnostic Test Evaluation Calculator (Version 23.0.9; accessed December 1, 2024). The software is available online at https://www.medcalc.org/calc/ diagnostic_test.php.
使用 MedCalc Software Ltd. 诊断测试评估计算器（版本 23.0.9;2024 年 12 月 1 日访问）计算诊断测试的敏感性和特异性以及 95% 置信区间。该软件可在 https://www.medcalc.org/calc/ diagnostic_test.php 在线获取。

3 | RESULTS  3 |结果

3.1 | Patient demographics and study overview
3.1 |患者人口统计学和研究概述

A total of 28 patients, accounting for 31 episodes of acute abdominal pain, were included in this study. The median age of the participants was 12 years (range: 6 months to 19 years). Of the 31 episodes, 19 (61%) were diagnosed as AP, while 12 (39%) were attributed to non-AP-related abdominal pain.
本研究共纳入 28 例患者，占急性腹痛发作 31 次。参与者的中位年龄为 12 岁 （范围：6 个月至 19 岁）。在这 31 次发作中，19 次 （61%） 被诊断为 AP，而 12 次 （39%） 归因于非 AP 相关的腹痛。
Presenting symptoms and findings from physical examinations were collected and summarized for both AP and non-AP groups, as shown in Table 1. Notably, one case involved a 6-monthold infant with significant developmental delay, making it challenging to evaluate abdominal pain clinically.
收集并总结了 AP 组和非 AP 组的症状和体格检查结果，如 表 1 所示。值得注意的是，1 例涉及一名 6 个月大的婴儿，患有明显的发育迟缓，这使得临床评估腹痛具有挑战性。
  1. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
    这是一篇根据知识共享署名-非商业性使用-禁止演绎许可条款的开放获取文章，允许在任何媒体中使用和分发，前提是正确引用原始作品，使用是非商业性的，并且不进行修改或改编。
    © 2025 The Author(s). Journal of Pediatric Gastroenterology and Nutrition published by Wiley Periodicals LLC on behalf of European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
    © 2025 作者。儿科胃肠病学和营养学杂志由 Wiley Periodicals LLC 代表欧洲儿科胃肠病学、肝病学和营养学学会和北美儿科胃肠病学、肝病学和营养学会出版。