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Clinical Chemistry 34: 2096-2102, 1988;
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Clinical Chemistry, Vol 34, 2096-2102, Copyright © 1988 by American Association for Clinical Chemistry

Multicenter evaluation of a specific pancreatic isoamylase assay based on a double monoclonal-antibody technique

NW Tietz, A Burlina, W Gerhardt, W Junge, P Malfertheiner, T Murai, M Otte, W Stein, M Gerber and G Klein
Department of Pathology, University of Kentucky, Lexington 40536.

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.


The following articles in journals at HighWire Press have cited this article:


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 Clin. Chem.Home page
Y. Morishita, Y. Iinuma, N. Nakashima, K. Majima, K. Mizuguchi, and Y. Kawamura
Total and Pancreatic Amylase Measured with 2-Chloro-4-nitrophenyl-4-O-{beta}-D-galactopyranosylmaltoside
Clin. Chem., July 1, 2000; 46(7): 928 - 933.
[Abstract] [Full Text] [PDF]


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Copyright © 1988 by the American Association for Clinical Chemistry.