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Clinical Chemistry, Vol 20, 825-833, Copyright © 1974 by the American Association for Clinical Chemistry
1 Clinical Laboratories and the Departments of Medicine, Pathology, and Statistics, University of Wisconsin, Madison, Wis.
53706.
We describe an approach for formulating criteria that can be used to judge whether an analytical method has acceptable precision and accuracy. We derive criteria for several experiments that are commonly used in method-evaluation studies: precision or replicates, recovery, interference, and comparison of patient values between the new method and a proven method. These criteria are based on the medical usefulness of the test results, thus the acceptability of the method is judged with respect to the clinical requirements.
Submitted on April 22, 1974
Accepted on May 10, 1974
The following articles in journals at HighWire Press have cited this article:
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  J. O. Westgard Use and Interpretation of Common Statistical Tests in Method Comparison Studies Clin. Chem., March 1, 2008; 54(3): 612 - 612. [Full Text] [PDF]
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C. G. Fraser and P. Hyltoft Petersen Analytical Performance Characteristics Should Be Judged against Objective Quality Specifications Clin. Chem., March 1, 1999; 45(3): 321 - 323. [Full Text] [PDF]
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J. O. Westgard Points of Care in Using Statistics in Method Comparison Studies Clin. Chem., November 1, 1998; 44(11): 2240 - 2242. [Full Text] [PDF]
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M. Nauck, W. Marz, and H. Wieland New immunoseparation-based homogeneous assay for HDL-cholesterol compared with three homogeneous and two heterogeneous methods for HDL-cholesterol Clin. Chem., July 1, 1998; 44(7): 1443 - 1451. [Abstract] [Full Text] [PDF]
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N. Rifai, E. Iannotti, K. DeAngelis, and T. Law Analytical and clinical performance of a homogeneous enzymatic LDL-cholesterol assay compared with the ultracentrifugation-dextran sulfate-Mg2+ method Clin. Chem., June 1, 1998; 44(6): 1242 - 1250. [Abstract] [Full Text] [PDF]
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P. H. Petersen, D. Stockl, O. Blaabjerg, B. Pedersen, E. Birkemose, L. Thienpont, J. F. Lassen, and J. Kjeldsen Graphical interpretation of analytical data from comparison of a field method with a Reference Method by use of difference plots Clin. Chem., November 1, 1997; 43(11): 2039 - 2046. [Abstract] [Full Text] [PDF]
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Y.-C. Huang, J.-T. Kao, and K.-S. Tsai Evaluation of two homogeneous methods for measuring high-density lipoprotein cholesterol Clin. Chem., June 1, 1997; 43(6): 1048 - 1055. [Abstract] [Full Text] [PDF]
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N. Harris, V. Galpchian, J. Thomas, E. Iannotti, T. Law, and N. Rifai Three generations of high-density lipoprotein cholesterol assays compared with ultracentrifugation/dextran sulfate–Mg2+ method Clin. Chem., May 1, 1997; 43(5): 816 - 823. [Abstract] [Full Text] [PDF]
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