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

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• 作者：Jarosław Walkowiak^a ; ^{jarwalk@ump.edu.pl" class="auth_mail" title="E-mail the corresponding author} ; Aleksandra Glapa^a ; Jan Krzysztof Nowak^a ; Lyudmyla Bober^b ; Nataliya Rohovyk^b ; Ewa Wenska-Chyży^a ; Paulina Sobkowiak^c ; Aleksandra Lisowska^a
• 关键词：Exocrine pancreatic insufficiency ; Specificity ; Sensitivity ; Qualitative test ; Point-of-care
• 刊名：Journal of Cystic Fibrosis
• 出版年：2016
• 出版时间：September 2016
• 年：2016
• 卷：15
• 期：5
• 页码：664-668
• 全文大小：441 K

文摘

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 < 200 μg/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.