Evaluation of a new urinary amylase test strip in the diagnosis of acute pancreatitis

We have developed a novel rapid test strip for detecting pancreatic amylase in urine and prospectively evaluated its accuracy in screening for acute p ancreatitis (AP). The test strip is based on the immunochromatography princ iple and uses two monoclonal antibodies specific for pancreatic amylase. Ur ine samples were collected from 500 consecutive patients with acute abdomin al disease.(52 with AP) and prospectively tested with the strip. The accura cy of the test strip was compared with that of two quantitative urine amyla se determinations and a urinary dipstick test for amylase (Rapignost). Sens itivity of the test was 69% and specificity was 97% in differentiating pati ents with AP from those with acute abdominal extrapancreatic disease at adm ission. The negative predictive value was 0.986. The test showed moderate a greement both with an assay measuring total amylase activity and with anoth er measuring pancreatic amylase immunoreactivity. At similar high specifici ty (97%), quantitative determination of total amylase activity (cut-off 396 0 U/L) and pancreatic amylase (cut-off 2180 mu g/L) showed lower sensitivit y (54% and 41%) than the test strip (69%). The test is specific and rapid t o perform, and it rules out AP with high probability. It could therefore be useful in an emergency setting without laboratory facilities in the differ ential diagnosis of acute abdominal pain.