用于快速评估囊性纤维化患者胰腺状态的胰弹性蛋白酶-1快速检测。

Pancreatic Elastase-1 Quick Test for rapid assessment of pancreatic status in cystic fibrosis patients.

作者信息

Walkowiak Jarosław, Glapa Aleksandra, Nowak Jan Krzysztof, Bober Lyudmyla, Rohovyk Nataliya, Wenska-Chyży Ewa, Sobkowiak Paulina, Lisowska Aleksandra

机构信息

Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Poznan, Poland.

出版信息

J Cyst Fibros. 2016 Sep;15(5):664-8. doi: 10.1016/j.jcf.2016.05.009. Epub 2016 Jun 7.

DOI:10.1016/j.jcf.2016.05.009

PMID:27287722

Abstract

BACKGROUND

At present, fecal elastase-1 ELISA determination is the most sensitive and specific tubeless pancreatic function test available. However, the results are not available the same day in routine clinical practice. This prospective study aims at evaluating the sensitivity and specificity of the Elastase-1 Quick™ Test by comparing the results with the ELISA test.

METHODS

The study was composed of three groups: the screening-diagnosed cystic fibrosis (CF) patients (n=28), the screened, but non-CF subjects (n=36) and non-screened CF patients (n=62). Pancreatic status (normal vs abnormal) was evaluated using the Pancreas Elastase-1 Quick™ Test. Fecal elastase-1 concentration was determined with a commercially available ELISA kit, used as reference. The cut-off for abnormal results was set at <200μg/g of stool.

RESULTS

The Pancreatic Elastase-1 Quick Test™ showed the following sensitivities and specificities in the studied groups: 92.8% and 96.6% in all subjects, 90.5% and 100% in screening samples, and 92.8 and 90.5% in CF patients.

CONCLUSION

Pancreatic Elastase-1 Quick Test™ proves to be a rapid and reliable option to qualitatively evaluate pancreatic function for diagnostic purposes in a clinical setting of CF care.

摘要

背景

目前，粪便弹性蛋白酶-1酶联免疫吸附测定（ELISA）是现有的最敏感且特异的无管胰腺功能检测方法。然而，在常规临床实践中，当天无法获得检测结果。这项前瞻性研究旨在通过将结果与ELISA检测进行比较，评估Elastase-1 Quick™检测的敏感性和特异性。

方法

该研究由三组组成：经筛查确诊的囊性纤维化（CF）患者（n = 28）、经筛查但非CF的受试者（n = 36）以及未经筛查的CF患者（n = 62）。使用胰腺弹性蛋白酶-1 Quick™检测评估胰腺状态（正常与异常）。采用市售ELISA试剂盒测定粪便弹性蛋白酶-1浓度，作为参考。异常结果的临界值设定为<200μg/g粪便。