Kemppainen E A, Hedström J I, Puolakkainen P A, Sainio V S, Haapiainen R K, Perhoniemi V, Osman S, Kivilaakso E O, Stenman U H
Second Department of Surgery, Helsinki University Central Hospital, Finland.
N Engl J Med. 1997 Jun 19;336(25):1788-93. doi: 10.1056/NEJM199706193362504.
Acute pancreatitis can be difficult to diagnose. We developed a rapid dipstick screening test for pancreatitis, based on the immunochromatographic measurement of urinary trypsinogen-2.
We prospectively compared the urinary trypsinogen-2 dipstick test with a quantitative urinary trypsinogen-2 assay, a urinary dipstick test for amylase, and serum and urinary amylase assays in 500 consecutive patients with acute abdominal pain at two emergency departments. Acute pancreatitis was diagnosed according to standardized criteria.
The urinary trypsinogen-2 dipstick test was positive in 50 of the 53 patients with acute pancreatitis (sensitivity, 94 percent), including all 7 with severe pancreatitis. Two patients with urinary trypsinogen-2 concentrations below the sensitivity threshold of the test (50 ng per milliliter) and one with a very high concentration had false negative results. The test was also positive in 21 of the 447 patients without pancreatitis (specificity, 95 percent), including 7 with abdominal cancers, 3 with cholangitis, and 2 with chronic pancreatitis. The sensitivity and specificity of the dipstick test were similar to those of the quantitative urinary trypsinogen-2 assay and higher than those of the urinary amylase dipstick test. The serum amylase assay had a sensitivity of 85 percent (with a cutoff value of 300 U per liter for the upper reference limit) and a specificity of 91 percent. The sensitivity and specificity of the urinary amylase assay (cutoff value, 2000 U per liter) were 83 and 88 percent, respectively.
In patients with acute abdominal pain seen in the emergency department, a negative dipstick test for urinary trypsinogen-2 rules out acute pancreatitis with a high degree of probability. A positive test usually identifies patients in need of further evaluation.
急性胰腺炎有时难以诊断。我们基于免疫层析法检测尿胰蛋白酶原-2，开发了一种用于胰腺炎的快速试纸条筛查试验。
我们前瞻性地比较了尿胰蛋白酶原-2试纸条试验与定量尿胰蛋白酶原-2检测、尿淀粉酶试纸条试验以及血清和尿淀粉酶检测，对两个急诊科连续就诊的500例急性腹痛患者进行了检测。急性胰腺炎根据标准化标准进行诊断。
53例急性胰腺炎患者中，50例尿胰蛋白酶原-2试纸条试验呈阳性（敏感性为94%），其中包括所有7例重症胰腺炎患者。2例尿胰蛋白酶原-2浓度低于试验敏感性阈值（每毫升50纳克）的患者和1例浓度非常高的患者出现假阴性结果。在447例非胰腺炎患者中，21例试验也呈阳性（特异性为95%），其中包括7例腹部癌症患者、3例胆管炎患者和2例慢性胰腺炎患者。试纸条试验的敏感性和特异性与定量尿胰蛋白酶原-2检测相似，高于尿淀粉酶试纸条试验。血清淀粉酶检测的敏感性为85%（上参考限临界值为每升300单位），特异性为91%。尿淀粉酶检测（临界值为每升2000单位）的敏感性和特异性分别为83%和88%。
在急诊科就诊的急性腹痛患者中，尿胰蛋白酶原-2试纸条试验阴性很可能排除急性胰腺炎。阳性试验通常可识别需要进一步评估的患者。
