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Background: Rapid urinary trypsinogen-2 dipstick test and levels of urinary trypsinogen-2 and trypsinogen activation peptide (TAP) concentration have been reported as prognostic markers for the diagnosis of acute pancreatitis., Aim: To reconfirm the validity of all these markers in the diagnosis of acute pancreatitis by undertaking a multi-center study in Japan., Methods: Patients with acute abdominal pain were recruited from 17 medical institutions in Japan from April 2009 to December 2012. Urinary and serum samples were collected twice, at enrollment and on the following day for measuring target markers. The diagnosis and severity assessment of acute pancreatitis were assessed based on prognostic factors and computed tomography (CT) Grade of the Japanese Ministry of Health, Labour, and Welfare criteria., Results: A total of 94 patients were enrolled during the study period. The trypsinogen-2 dipstick test was positive in 57 of 78 patients with acute pancreatitis (sensitivity, 73.1%) and in 6 of 16 patients with abdominal pain but without any evidence of acute pancreatitis (specificity, 62.5%). The area under the curve (AUC) score of urinary trypsinogen-2 according to prognostic factors was 0.704, which was highest in all parameter. The AUC scores of urinary trypsinogen-2 and TAP according to CT Grade were 0.701 and 0.692, respectively, which shows higher than other pancreatic enzymes. The levels of urinary trypsinogen-2 and TAP were significantly higher in patients with extended extra-pancreatic inflammation as evaluated by CT Grade., Conclusion: We reconfirmed urinary trypsinogen-2 dipstick test is useful as a marker for the diagnosis of acute pancreatitis. Urinary trypsinogen-2 and TAP may be considered as useful markers to determine extra-pancreatic inflammation in acute pancreatitis., Competing Interests: Conflict-of-interest statement: The qualitative and quantitative analyses of urinary trypsinogen-2 were performed free of charge by Unitika Ltd. (Osaka, Japan). Mayumi T received research funding. The other authors declare no conflict of interest.

Objectives: A simple urinary trypsinogen-2 test was evaluated for the diagnosis of acute pancreatitis., Methods: This prospective multicenter study enrolled consecutive patients with acute abdominal pain who presented to the emergency department or who were hospitalized at 1 of 21 medical institutions in Japan. Patients were tested with urinary trypsinogen-2 dipstick test and a quantitative trypsinogen-2 assay, and these values were compared with serum amylase and lipase findings., Results: A total of 412 patients were enrolled. The trypsinogen-2 dipstick test was positive in 107 of 156 patients with acute pancreatitis (sensitivity, 68.6%) and in 33 of 256 patients with nonpancreatic abdominal pain (specificity, 87.1%). The sensitivity for the diagnosis of pancreatitis caused by alcohol and gallstones by the dipstick test was 72.2% and 81.8%, respectively, which was much higher than those associated with amylase testing. There are several degrees of positivity within the urinary trypsinogen-2 dipstick test. Modification of the cutoff point such that positive (+) and most positive (++) results were interpreted as a positive result, the specificity and positive likelihood ratio increased to 92.2% and 7.63, respectively., Conclusions: This simple, rapid, easy, and noninvasive urinary trypsinogen-2 test can diagnose or rule out most cases of acute pancreatitis.