Precision and Accuracy: Concepts and Assessment by Method Evaluation Testing

References

• Aronsson T., de Verdier C-H., Groth T. Factors influencing the quality of analytical methods—a systems analysis, with use of computer simulation. Clin. Chem. 1974; 20: 738
   PubMed Web of Science ®Google Scholar
• Arthur G. L., Rawnsley H. M. Statistical analysis of method comparison. Advanced Clinical Chemistry No. ACC-23. American Society of Clinical Pathologists. 1977; 1
   Google Scholar
• ASTM. American Society of Testing and Materials, Philadelphia 1971, Standard E177–71: Standard recommended practice for use of the terms precision and accuracy as applied to measurement of a property of a material
   Google Scholar
• Bantett R. N. Medical significance of laboratory results. Am. J. Clin. Pathol. 1968; 50: 671
   Google Scholar
• Barnett R. N. A scheme for the comparison of quantitative methods. Am. J. Clin. Pathol 1965; 43: 562
   PubMed Web of Science ®Google Scholar
• Barnett R. N., Youden W. J. A revised scheme for the comparison of quantitative methods. Am. J. Clin. Pathol 1970, Suppl. 54: 454
   Google Scholar
• Bartlett M. S. Fitting a straight line when both variables are subject to error. Biometrics 1949; 5: 207
   Web of Science ®Google Scholar
• A National Understanding for the Development of Reference Materials and Methods for Clinical Chemistry, J. H. Boutwell. American Association for Clinical Chemistry, Washington, DC 1978
   Google Scholar
• Brooks R. J. Clinical chemistry method documentation. Lab. World May, 1979; 30
   Google Scholar
• Broughton P. M. G. Evaluation of analytical methods in clinical chemistry. Progress in Clinical Pathology, M. Stefanini. Grune & Stratton, New York 1977; Vol. 7: 1
   Google Scholar
• Broughton P. M. G., Buttolph M. A., Gowenlock A. H., Skentelbery R. G., Neill D. W. Recommended scheme for the evaluation of instruments for automatic analysis in the clinical biochemistry laboratory. J. Clin. Path. 1969; 22: 278
   PubMed Web of Science ®Google Scholar
• Broughton P. M. G., Gowenlock A. H., McCormack J. J., Neill D. W. A revised scheme for the evaluation of automatic instruments for use in clinical chemistry. Ann. Clin. Biochem. 1974; 11: 207
   PubMed Web of Science ®Google Scholar
• Buttner J., Borth R., Boutwell J. H., Broughton P. M. G. International Federation of Clinical Chemistry provisional recommendation of quality control in clinical chemistry. I. General principles and terminology. Clin. Chim. Acta 1975; 63: F25
   Google Scholar
• Buttner J., Borth R., Boutwell J. H., Broughton P. M. G., Bowyer R. C. International Federation of Clinical Chemistry provisional recommendation on quality control in clinical chemistry. II. Assessment of analytical methods for routine use. Clin. Chim. Acta 1976; 69: F1
   PubMed Web of Science ®Google Scholar
• Buttner J., Borth R., Boutwell J. H., Broughton P. M. G., Bowyer R. C. International Federation of Clinical Chemistry provisional recommendation on quality control in clinical chemistry. III. Calibration and control materials. Clin. Chem. 1977; 23: 1784
   Google Scholar
• Buttner J., Borth R., Broughton P. M. G., Bowyer R. C. International Federation of Clinical Chemistry provisional recommendation on quality control in clinical chemistry. IV. Internal quality control. Clin. Chim. Acta
   Google Scholar
• Buttner J., Borth R., Boutwell J. H., Broughton P. M. G., Bowyer R. C. International Federation of Clinical Chemistry provisional recommendation on quality control in clinical chemistry. V. External quality control. Clin. Chem. 1978; 24: 1213
   Web of Science ®Google Scholar
• Buttner J., Borth R., Boutwell J. H., Broughton P. M. G., Bowyer R. C. International Federation of Clinical Chemistry provisional recommendation on quality control in clinical chemistry. VI. Quality requirements from the point of view of health care. Clin. Chem. 1977; 23: 1066
   Google Scholar
• Cali J. P., Bowers G. N., Young D. S. A reference method for the determination of total calcium in serum. Clin. Chem. 1973; 19: 1208
   PubMed Web of Science ®Google Scholar
• Carey R. N., Wold S., Westgard J. O. Principal component analysis: an alternative to reference methods. Anal. Chem. 1975; 47: 1824
   PubMed Web of Science ®Google Scholar
• Cembrowski G. S., Westgard J. O., Conover W. J., Toren E. C., Jr. Statistical analysis of method comparison data: testing normality. Am. J. Clin. Pathol. 1979; 72: 21
   Google Scholar
• Cooper G. R. Clinical chemistry methods. I. Selection and evaluation. U. S. Department of Health, Education, and Welfare. April, 1979; 1, CDC 79–58
   Google Scholar
• Cornbleet P. J., Gochman N. Incorrect least-squares regression coefficients in method-comparison analysis. Clin. Chem. 1979; 25: 432
   PubMed Web of Science ®Google Scholar
• Cornbleet P. J., Shea M. C. Comparison of product moment and rank correlation coefficients in the assessment of laboratory method-comparison data. Clin. Chem. 1978; 24: 857
   Google Scholar
• Cotlove E., Harris E. K., Williams G. Z. Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. III. Physiological and medical implications. Clin. Chem. 1970; 16: 1028
   PubMed Web of Science ®Google Scholar
• Currie L. A., DeVoe J. R. Systematic error in chemical analysis. Validation of the Measurement Process, J. R. DeVoe. ACS Symposium Series, American Chemical Society, Washington, D. C. 1977; 114
   Google Scholar
• Davis R. B., Thompson J. E., Pardue H. L. Characteristics of statistical parameters used to interpret least-squares results. Clin. Chem. 1978; 24: 611
   PubMedGoogle Scholar
• Deming W. E. Statistical Adjustment of Data. John Wiley & Sons, New York 1943; 184
   Google Scholar
• Eckschlager K. Criterion for judging the acceptability of analytical methods. Anal. Chem. 1972; 44: 878
   Google Scholar
• Eisenhart C. Realistic evaluation of the precision and accuracy of instrument calibration systems. J. Res. Natl. Bureau of Standards - C: Engineering and Instrumentation 1963; 67C: 161
   Google Scholar
• Eisenhart C. Expression of the uncertainties of final results. Science 1968; 160: 1201
   PubMed Web of Science ®Google Scholar
• CAP Aspen Conference 1976: Analytical Goals in Clinical Chemistry, F. R. Elevitch. College of American Pathologists, Skokie 1977; 111
   Google Scholar
• Elevitch F. R., Barnett R., von Boroviczeny K-G., Brown S. S., Burlina A., Copeland B., Eldjarn L., Flynn F. V., Gilbert R. K., Harris E., Healy M. J. R., Killander J., Rawnsley H. M., Rinsler M. G., Whitby L. G. Analytical goals in clinical chemistry: their relationship to medical care. Am. J. Clin. Pathol. 1979; 71: 624
   PubMedGoogle Scholar
• Elion-Gerritzen W. E. Analytic precision in clinical chemistry and medical decisions. Am. J. Clin. Pathol. 1980; 73: 184
   Google Scholar
• Ellis K. J., Duggleby R. G. What happens when data are fitted to the wrong equation?. Biochem. J. 1978; 171: 513
   PubMed Web of Science ®Google Scholar
• Filliben J. J. Testing basic assumptions in the measurement process. Validation of the Measurement Process, J. R. DeVoe. ACS Symposium Series, American Chemical Society, Washington, D. C. 1977; 30
   Google Scholar
• Fung C. A., Hunter W. G. Discussion of statistical comparison of multiple analytic procedures: application to clinical chemistry. Technometrics 1979; 21: 411
   Google Scholar
• Galen R. S., Gambino S. R. Beyond Normality: The Predictive Value and Efficiency of Medical Diagnoses. John Wiley & Sons, New York 1975
   Google Scholar
• Garber C. C., Westgard J. O., Milz L., Larson F. C. DuPont aca III performance as tested according to NCCLS guidelines. Clin. Chem. 1979; 25: 1730
   Google Scholar
• Gilbert R. K. Progress and analytic goals in clinical chemistry. Am. J. Clin. Pathol. 1975; 63: 960
   PubMed Web of Science ®Google Scholar
• Gindler E. Some nonparametric statistical tests for quick evaluation of clinical data. Clin. Chem. 1975; 21: 309
   Google Scholar
• Glick J. H. Expression of random analytical error as a percentage of the range of clinical interest. Clin. Chem. 1976; 22: 475
   PubMedGoogle Scholar
• Guide for use of terms in reporting data in analytical chemistry. Anal. Chem. 1975; 47: 2527
   Google Scholar
• Harris E. K. Statistical principles underlying analytic goal-setting in clinical chemistry. Am. J. Clin. Pathol. 1979; 72: 374
   PubMed Web of Science ®Google Scholar
• Assessing quality requirements in clinical chemistry, M. Hørder, P. Petersen, A report by a project group initiated by the Nordic Project for Clinical Chemistry (NORDKEM): Garby, L., Groth, T., Gräsbeck, R., Hilden, J., Hyltoft Petersen, P., Hørder, M., Jacobson, G., Matzen, P., Solberg, H. E., de Verdier, C.-H., Wide, L., and Winkel, P., Scand. J. Clin. Lab. Invest., 40(Suppl. 155), 1980.
   Google Scholar
• Kim E. K., Logan J. E. A scheme for the evaluation of methods in clinical chemistry with particular application to those measuring enzyme activities. I. General considerations. Clin. Biochem. 1978; 11: 238
   PubMed Web of Science ®Google Scholar
• Kim E. K., Logan J. E. A scheme for the evaluation of methods in clinical chemistry with particular application to those measuring enzyme activities. II. Analysis of data and performance assessment. Clin. Biochem. 1978; 11: 244
   Google Scholar
• Klein R., Jr., Hack C. Standard additions—uses and limitations in spectrophotometric analyses. Am. Lab. 1977; 21
   Google Scholar
• Krause R. D., Lott J. A. Use of the Simplex method to optimize analytical conditions in clinical chemistry. Clin. Chem. 1974; 20: 775
   PubMed Web of Science ®Google Scholar
• Laessig R. H., Schwartz T. H., Paskey T. A. Determination of SMA-Mark X set points for bilirubin by standard addition technique. Clin. Chem. 1972; 18: 48
   Google Scholar
• LaFleur P. D., Uriano G. A. Reference materials and methods in clinical analyses. Crit. Rev. Anal. Chem. 1977; 6: 367
   Google Scholar
• Lawton W. H., Sylvestre E. A., Young B. J. Statistical comparison of multiple analytic procedures: Application to clinical chemistry. Technometrics 1979; 21: 397
   Google Scholar
• Levine S., Miller R. G. Some comments on the judgment of the acceptability of new clinical methods. Clin. Chem. 1977; 23: 774
   Google Scholar
• Logan J. E. Evaluation of commercial kits. Crit. Rev. Clin. Lab. Sci. 1972; 3: 271
   Google Scholar
• London J. W., Shaw L. M., Fetterolf D., Garfinkel D. A systematic approach to enzyme assay optimization, illustrated by aminotransferase assays. Clin. Chem. 1975; 21: 1939
   Google Scholar
• McFarren E. G., Lishka R. J., Parker J. H. Criterion for judging acceptability of analytical methods. Anal. Chem. 1970; 42: 358
   PubMed Web of Science ®Google Scholar
• Mandel J., Nanni L. G. Measurement evaluation. Quality Assurance Practices for Health Laboratories, S. L. Inhorn. American Public Health Association. 1978; 209
   Google Scholar
• Massart D. L., Dijkstra A., Kaufman L. Evaluation and Optimization of Laboratory Methods and Analytical Procedures—A Survey of Statistical and Mathematical Techniques. Elsevier Scientific Publishing Co., New York 1978
   Google Scholar
• Mather A. A critical approach to the evaluation of automated systems in clinical chemistry. Progress in Clinical Pathology, M. Stefanini. Grune & Stratton, New York 1975; Vol. 6: 1
   Google Scholar
• Midgley D. Criterion for judging the acceptability of analytical methods. Anal. Chem. 1977; 49: 410
   Google Scholar
• Mitchell F. L. The pursuit of analytical accuracy in the clinical laboratory. Lab-Lore 1978; 8: 527
   Google Scholar
• Murphy R. B. On the Meaning of Precision and Accuracy. National Bureau of Standards. Spec. Publ. No. 300, U.S. Government Printing Office, Washington, D. C. 1969; Vol. I: 357
   Google Scholar
• NCCLS. Response to Recommendations Arising from the Conference on an Understanding for a National Reference System in Clinical Chemistry. National Committee for Clinical Laboratory Standards, Villanova, Pa. 1978
   Google Scholar
• NCCLS. Proposed Standard PSEP-2, Protocol for Establishing Performance Claims for Clinical Chemical Methods—Introduction and Performance Check Experiment. Instrument Evaluation Subcommittee of the Evaluation Protocols Area Committee. National Committee for Clinical Laboratory Standards, Villanova, Pa. 1979
   Google Scholar
• NCCLS. Proposed Standard PSEP-3, Protocol for Establishing Performance Claims for Clinical Chemical Methods—Replication Experiment. Instrument Evaluation Subcommittee of the Evaluation Protocols Area Committee. National Committee for Clinical Laboratory Standards, Villanova, Pa. 1979
   Google Scholar
• NCCLS. Proposed Standard PSEP-4, Protocol for Establishing Performance Claims for Clinical Chemical Methods—Comparison of Methods Experiment. Instrument Evaluation Subcommittee of the Evaluation Protocols Area Committee. National Committee for Clinical Laboratory Standards, Villanova, Pa. 1979
   Google Scholar
• NCCLS. National Committee for Clinical Laboratory Standards, Villanova, Pa. 1977, Proposed Standard PSC-5, Methodological Principles for Establishing Principal Assigned Values to Calibrators
   Google Scholar
• NCCLS. National Committee for Clinical Laboratory Standards, Villanova, Pa. 1979, Proposed Standard PSC-13, Nomenclature and Definitions for Use in the National Reference System in Clinical Chemistry
   Google Scholar
• NCCLS. Proposed Standard PSC-15, Guidelines for the Development of Definitive Methods for Use in Clinical Chemistry for the National Reference System in Clinical Chemistry. LCouncil for the National Reference System in Clinical Chemistry. National Committee for Clinical Laboratory Standards, Villanova, Pa. 1979; 1
   Google Scholar
• NCCLS. Proposed Document PSC-16, Guidelines for the Development of Reference Methods in Clinical Chemistry for the National Reference System in Clinical Chemistry. Council for the National Reference System in Clinical Chemistry. National Committee for Clinical Laboratory Standards, Villanova, Pa. 1979; 1
   Google Scholar
• Neese J. W., Duncan P., Bayse D., Robinson M., Cooper T., Stewart C. Development and Evaluation of a hexokinase/glucose-6-phosphate Dehydrogenase Procedure for Use as a National Glucose Reference Method. Center for Disease Control. HEW Publ. No. (CDC) 77–8330, Public Health Service, U.S. Department of Health, Education and Welfare, Atlanta 1976
   Google Scholar
• Passey R. B., Gillum R. L., Fuller J. B., Urry F. M., Giles M. L. Evaluation and comparison of 10 glucose methods and the reference method recommended in the proposed product class standard (1974). Selected Methods of Clinical Chemistry. American Association for Clinical Chemistry. 1977; Vol. 8: 9
   Google Scholar
• Proposed establishment of product class standard for detection or measurement of glucose. June 28, 1974; 126–24136, Federal Register 39
   Google Scholar
• Rautela G. S., Liedtke R. J. Automated enzymic measurement of total cholesterol in serum. Clin. Chem. 1978; 24: 108
   Google Scholar
• Rautela G. S., Snee R. D., Miller W. K. Response-surface cooptimization of reaction conditions in clinical chemical methods. Clin. Chem. 1979; 25: 1954
   PubMedGoogle Scholar
• Ross J. W., Fraser M. D. Analytical clinical laboratory precision: State of the art for twenty-nine analytes. Am. J. Clin. Pathol 1979; 72: 265
   Google Scholar
• Shaikh A. H. A systematic procedure for selection of automated instruments in the clinical laboratory. Am. J. Med. Technol. 1979; 45: 710
   Google Scholar
• Skendzel L. P., Youden W. J. A graphic display of interlaboratory test results. Am. J. Clin. Pathol 1969; 51: 161
   PubMed Web of Science ®Google Scholar
• Steele B. W., Schauble M. K., Becktel J. M., Bearman J. E. Evaluation of clinical chemistry laboratory performance in twenty veterans administration hospitals. Am. J. Clin. Pathol. 1977; 67: 594
   Google Scholar
• Tietz N. W. A model for a comprehensive measurement system in clinical chemistry. Clin. Chem. 1979; 25: 833
   PubMed Web of Science ®Google Scholar
• Tonks D. B. A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. Clin. Chem. 1963; 9: 217
   PubMed Web of Science ®Google Scholar
• Tonks D. B. A quality control program for quantitative clinical chemistry estimations. Can. J. Med. Technol April, 1968; 38
   Google Scholar
• Uriano G. A., Cali J. P. Role of reference materials and reference methods in the measurement process. Validation of the Measurement Process, J. R. DeVoe. ACS Symposium Series, American Chemical Society, Washington, D. C. 1977; 140
   Google Scholar
• Uriano G. A., Gravatt C. C. The role of reference materials and reference methods in chemical analysis. Crit. Rev. Anal. Chem. 1977; 6: 361
   Web of Science ®Google Scholar
• Vecchio T. Predictive value of a single diagnostic test in unselected populations. N. Engl. J. Med. 1966; 274: 1171
   PubMed Web of Science ®Google Scholar
• Vikelsoe J., Bechgaard E., Magid E. A procedure for the evaluation of precision and accuracy of analytical methods. Scand. J. Clin. Lab. Invest. 1974; 34: 149
   PubMed Web of Science ®Google Scholar
• Wakkers P. J. M., Hellendoorn H. B. A., Op de Weegh G. J., Heerspink W. Applications of statistics in clinical chemistry. A critical evaluation of regression lines. Clin. Chim. Acta 1975; 64: 173
   PubMedGoogle Scholar
• Werner M., Brooks S. H., Knott L. B. Additive, multiplicative, and mixed analytical errors. Clin. Chem. 1978; 24: 1895
   Google Scholar
• Wernimont G. Statistical control of measurement process. Validation of the Measurement Process, J. R. DeVoe. ACS Symposium Series, American Chemical Society, Washington, D. C. 1977; 1
   Google Scholar
• Westgard J. O., Carey R. N., Feldbruegge D. H., Jenkins L. M. Performance studies on the Technicon SMAC analyzer: precision and comparison of values with methods in routine laboratory service. Clin. Chem. 1976; 22: 489
   PubMed Web of Science ®Google Scholar
• Westgard J. O., Carey R. N., Hewitt T. E., Wold S., Joiner B. Design considerations in testing aspartate aminotransferase (AST) methods. Quality Control in Laboratory Medicine, J. B. Henry, J. Giegel. Masson Publishing, New York 1978; 141
   Google Scholar
• Westgard J. O., Carey R. N., Wold S. Criteria for judging precision and accuracy in method development and evaluation. Clin. Chem. 1974; 20: 825
   PubMed Web of Science ®Google Scholar
• Westgard J. O., de Vos D. J., Hunt M. R., Quam E. F., Carey R. N., Garber C. C. Concepts and practices in the evaluation of laboratory methods. I. Background and approach. Am. J. Med. Technol 1978; 44: 290
   Google Scholar
• Westgard J. O., de Vos D. J., Hunt M. R., Quam E. F., Carey R. N., Garber C. C. Concepts and practices in the evaluation of laboratory methods. II. Experimental procedures. Am. J. Med. Technol 1978; 44: 420
   Google Scholar
• Westgard J. O., de Vos D. J., Hunt M. R., Quam E. F., Carey R. N., Garber C. C. Concepts and practices in the evaluation of laboratory methods. III. Statistics. Am. J. Med. Technol. 1978; 44: 552
   Google Scholar
• Westgard J. O., de Vos D. J., Hunt M. R., Quam E. F., Carey R. N., Garber C. C. Concepts and practices in the evaluation of laboratory methods. IV. Decisions on acceptability. Am. J. Med. Technol. 1978; 44: 727
   Google Scholar
• Westgard J. O., de Vos D. J., Hunt M. R., Quam E. F., Carey R. N., Garber C. C. Concepts and practices in the evaluation of laboratory methods. V. Applications. Am. J. Med Technol 1978; 44: 803
   Google Scholar
• Westgard J. O., de Vos D. J., Hunt M. R., Quam E. F., Carey R. N., Garber C. C. Method Evaluation. American Society for Medical Technology, Houston 1978
   Google Scholar
• Westgard J. O., Falk H., Groth T. Influence of a between-run component of variation, choice of control limits, and shape of error distribution on the performance characteristics of rules for internal quality control. Clin. Chem. 1979; 25: 394
   PubMed Web of Science ®Google Scholar
• Westgard J. O., Hunt M. R. Use and interpretation of common statistical tests in method-comparison studies. Clin. Chem. 1973; 19: 49
   PubMed Web of Science ®Google Scholar
• Wilson A. L. The performance-characteristics of analytical methods. I. Talanta 1970; 17: 21
   PubMed Web of Science ®Google Scholar
• Wilson A. L. The performance-characteristics of analytical methods. II. Talanta 1970; 17: 31
   Google Scholar
• Wilson A. L. The performance-characteristics of analytical methods. III. Talanta 1973; 20: 725
   Google Scholar
• Wilson A. L. Performance-characteristics of analytical methods. IV. Talanta 1974; 21: 1109
   PubMed Web of Science ®Google Scholar
• Wilson A. L. Approach for achieving comparable analytical results from a number of laboratories. Analyst 1979; 104: 273
   Google Scholar
• Wilson A. L. Accuracy of determination of chloride in river waters: analytical quality control in the harmonised monitoring scheme. Analyst 1979; 104: 290
   Google Scholar
• Wu G. T., Twomey S. L., Thiers R. E. Statistical evaluation of method-comparison data. Clin. Chem. 1975; 21: 315
   Google Scholar
• Youden W. J. Statistical Techniques for Collaborative Tests. Association of Official Analytical Chemists, Washington, D. C. 1969
   Google Scholar
• Grannis G. F., Miller W. G. On the design of clinical chemistry quality-control sera. Clin. Chem. 1976; 22: 500
   PubMed Web of Science ®Google Scholar
• Grannis G. F. Interlaboratory survey of enzyme analyses. Am. J. Clin. Pathol. 1976; 66: 206
   PubMed Web of Science ®Google Scholar
• Caragher T. E., Grannis G. F. Performance evaluation of multi-channel analyzers by use of linearly-related survey specimens. Clin. Chem. 1978; 24: 403
   PubMedGoogle Scholar
• Grannis G. F., Massion C. G., Batsakis J. G. The 1978 College of American Pathologists survey of analyses of five serum enzymes by 450 laboratories. Am. J. Clin. Pathol. 1979, Suppl. 72: 285
   Google Scholar