title: Evaluation of a rapid urine amylase test using post-ERCP hyperamylasemia as a model.
abstract: OBJECTIVE
  The initial diagnosis of acute pancreatitis is often based on clinical criteria together with elevations of serum amylase and lipase. A reliable bedside urine test could facilitate the early diagnosis of pancreatitis. We evaluated a rapid urine amylase test (Rapignost) by using post-ERCP hyperamylasemia as a human model of acute development of hyperamylasemia suggestive of pancreatitis.
  
  
  METHODS
  Seventy-five patients undergoing ERCP were prospectively evaluated. Patients with renal insufficiency, hyperlipidemia, or hyperglycemia were excluded. Before ERCP, patients had serum amylase and lipase measured, and urine amylase tested with the Rapignost test strip. At 4 and 16-24 h post-ERCP, a serum and urine (test strip) amylase were measured again; the adequacy of urine collection was verified by measuring a 2-h creatinine clearance. Patients were clinically assessed for the development of clinical pancreatitis. The concordance of the strip result with post-ERCP hyperamylasemia was assessed.
  
  
  RESULTS
  The sensitivity of the test strip for the detection of hyperamylasemia was greatest at 16-24 h post-ERCP (78%). Specificity was uniformally high (100% specificity at 16-24 h post-procedure). The test strip was positive in all cases of clinical pancreatitis. Of three cases of clinically evident ERCP-induced pancreatitis, only one was urine test strip positive by 4 h post-procedure.
  
  
  CONCLUSIONS
  Using post-ERCP hyperamylasemia as a model, the Rapignost rapid urine amylase test strip was only marginally sensitive but highly specific for hyperamylasemia. The urine test strip was positive in all cases of clinical pancreatitis and may be a useful bedside test for the diagnosis of acute pancreatitis.
authors.affiliation: Department of Medicine, University Hospitals of Cleveland and Case Western Reserve University School of Medicine, Ohio 44106, USA.
authors.forename: M J
authors.initials: MJ
authors.lastname: Hegewald
authors.forename: G
authors.initials: G
authors.lastname: Isenberg
authors.forename: R K
authors.initials: RK
authors.lastname: Sterling
authors.forename: G S
authors.initials: GS
authors.lastname: Cooper
authors.forename: A
authors.initials: A
authors.lastname: Chak
authors.forename: M V
authors.initials: MV
authors.lastname: Sivak
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000681:Amylases / Q000097:blood* / Q000652:urine*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000097:blood / Q000175:diagnosis* / Q000652:urine; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D000681:Amylases