Tietz N W, Burlina A, Gerhardt W, Junge W, Malfertheiner P, Murai T, Otte M, Stein W, Gerber M, Klein G
Department of Pathology, University of Kentucky, Lexington 40536.
Clin Chem. 1988 Oct;34(10):2096-102.
Eleven evaluators from nine laboratories in five countries evaluated a new immunoinhibition method for pancreatic isoamylase determination that is as simple to perform as that for total amylase. The precision at low and intermediate activity concentrations was superior, and at high concentrations it equalled that of the wheat-germ inhibitor method. The test was linear to approximately 2000 U/L, depending on the instrumentation used. The percentage salivary isoamylase activities remaining in specimens after reaction with two monoclonal antibodies ranged from 2 to 4.4%. Comparative studies showed good correlation with the wheat-germ inhibitor (r greater than 0.978) and electrophoresis methods (r = 0.920). Hemolysis, lipemia, and bilirubinemia have no effect on results. Interlaboratory studies demonstrated excellent transferability of the method, if instruments are calibrated with the same calibrator. Reference intervals for pancreatic isoamylase are 13 to 64 U/L (25 degrees C), 13 to 83 U/L (30 degrees C), and 17 to 115 U/L (37 degrees C). A clinical evaluation of patients with acute pancreatitis showed that pancreatic isoamylase has a greater clinical sensitivity than total amylase.
来自五个国家九个实验室的11名评估人员对一种用于测定胰腺异淀粉酶的新免疫抑制方法进行了评估，该方法操作起来与测定总淀粉酶的方法一样简单。在低活性和中等活性浓度下，其精密度更高，在高浓度下，其精密度与麦芽胚抑制剂法相当。根据所使用的仪器不同，该检测方法在约2000 U/L范围内呈线性。与两种单克隆抗体反应后，标本中残留的唾液异淀粉酶活性百分比在2%至4.4%之间。对比研究表明，该方法与麦芽胚抑制剂法（r大于0.978）和电泳法（r = 0.920）具有良好的相关性。溶血、脂血和黄疸对结果无影响。实验室间研究表明，如果使用相同的校准品对仪器进行校准，该方法具有出色的可转移性。胰腺异淀粉酶的参考区间为13至64 U/L（25℃）、13至83 U/L（30℃）和17至115 U/L（37℃）。对急性胰腺炎患者的临床评估表明，胰腺异淀粉酶的临床敏感性高于总淀粉酶。
