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Editorials |
1
Directorate of Biochemical Medicine, Ninewells Hospital and Medical School, Dundee, Scotland DD1 9SY,
2
Department of Clinical Biochemistry, Odense University Hospital, DK-6000 Odense C, Denmark
a Author for correspondence. Fax 44 (0)1382 645333; e-mail callumf@dth.scot.nhs.uk.
The discipline of clinical chemistry is dynamic. Even a superficial glance at contents pages of the Journal over recent years demonstrates a marked evolution of the field. Appropriately, the Information for authors has also changed over the years to reflect new concepts of what constitutes an acceptable publication.
Readers of the Journal may have noticed an addition to the 1999 Information for authors (1), under the heading Description of Analytical Methods and Results, namely:
"Analytical quality. Results obtained for the performance characteristics should be compared objectively to well-documented quality specifications, e.g., published data on the state of the art, performance required by regulatory bodies such as CLIA `88, or recommendations documented by expert professional groups". In addition, quality specifications can be derived from analysis of performance on clinical decision-making.
Many manuscripts deal with the development of new analytical methods or evaluation of commercially available analytical systems. Experimental designs and statistical techniques used to derive data on imprecision and bias are generally more than satisfactory. This is hardly surprising in view of the very many published protocols for the evaluation of methods (2). In contrast, objective analysis of whether the imprecision and bias are satisfactory is often less well done.
This is not a new phenomenon. Although the idea of utilizing quality
specifications in assessing the acceptability of method performance was
firmly stated in 1974 (3), it was pointed out more than a
decade ago that few evaluators actually did compare the performance
achieved with preset quality specifications (4)(5). This
seems rather difficult to understand because quality specifications
based on the state of the art (6), the views of an expert
individual (7), and biological variation (8) had
been available for many years.
assessment of the effect of analytical performance on clinical
decision-making
Quality specifications in specific clinical situations.
General quality specifications based on medical needs.
professional recommendations
Guidelines from national or international expert groups.
Guidelines from expert individuals or institutional groups.
quality specifications laid down by regulation or by eqas
organizers
Quality specifications laid down by regulation.
Quality specifications laid down by EQAS organizers.
published data on the state of the art
Published data from external quality assessment and proficiency
testing schemes.
Published methodology.
References
The following articles in journals at HighWire Press have cited this article:
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  T. S.M. Reijn, M. O. Rikkert, W. J.A. van Geel, D. de Jong, and M. M. Verbeek Diagnostic Accuracy of ELISA and xMAP Technology for Analysis of Amyloid {beta}42 and Tau Proteins Clin. Chem., May 1, 2007; 53(5): 859 - 865. [Abstract] [Full Text] [PDF]
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 R. S. Vasan Biomarkers of Cardiovascular Disease: Molecular Basis and Practical Considerations Circulation, May 16, 2006; 113(19): 2335 - 2362. [Full Text] [PDF]
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D. K. Talwar, M. K. Azharuddin, C. Williamson, Y. P. Teoh, D. C. McMillan, and D. St. J. O'Reilly Biological Variation of Vitamins in Blood of Healthy Individuals Clin. Chem., November 1, 2005; 51(11): 2145 - 2150. [Abstract] [Full Text] [PDF]
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N. Q. Hanson, J. H. Eckfeldt, K. Schwichtenberg, O. Aras, and M. Y. Tsai Interlaboratory Variation of Plasma Total Homocysteine Measurements: Results of Three Successive Homocysteine Proficiency Testing Surveys Clin. Chem., September 1, 2002; 48(9): 1539 - 1545. [Abstract] [Full Text] [PDF]
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D. B. Sacks, D. E. Bruns, D. E. Goldstein, N. K. Maclaren, J. M. McDonald, and M. Parrott Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus Clin. Chem., March 1, 2002; 48(3): 436 - 472. [Abstract] [Full Text] [PDF]
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G. Phillipov and P. J. Phillips Components of Total Measurement Error for Hemoglobin A1c Determination Clin. Chem., October 1, 2001; 47(10): 1851 - 1853. [Full Text] [PDF]
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J. C. Boyd and D. E. Bruns Quality Specifications for Glucose Meters: Assessment by Simulation Modeling of Errors in Insulin Dose Clin. Chem., February 1, 2001; 47(2): 209 - 214. [Abstract] [Full Text] [PDF]
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X. Fuentes-Arderiu, J. Miro-Balague, P. Hyltoft Petersen, and C. G. Fraser State of the Art Instead of Biological Variation to Set Requirements for Imprecision Following is a reply to the above letter by X. Fuentes-Arderiu and J. Miro-Balague Clin. Chem., October 1, 2000; 46(10): 1715 - 1717. [Full Text] [PDF]
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E. Nexo, F. Engbaek, P. M. Ueland, C. Westby, P. O'Gorman, C. Johnston, B. F. Kase, A. B. Guttormsen, I. Alfheim, J. McPartlin, et al. Evaluation of Novel Assays in Clinical Chemistry: Quantification of Plasma Total Homocysteine Clin. Chem., August 1, 2000; 46(8): 1150 - 1156. [Abstract] [Full Text] [PDF]
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D. Talwar, H. Davidson, J. Cooney, and D. St. JO'Reilly Vitamin B1 Status Assessed by Direct Measurement of Thiamin Pyrophosphate in Erythrocytes or Whole Blood by HPLC: Comparison with Erythrocyte Transketolase Activation Assay Clin. Chem., May 1, 2000; 46(5): 704 - 710. [Abstract] [Full Text] [PDF]
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A. H. Garde, A. M. Hansen, L. T. Skovgaard, and J. M. Christensen Seasonal and Biological Variation of Blood Concentrations of Total Cholesterol, Dehydroepiandrosterone Sulfate, Hemoglobin A1c, IgA, Prolactin, and Free Testosterone in Healthy Women Clin. Chem., April 1, 2000; 46(4): 551 - 559. [Abstract] [Full Text] [PDF]
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G. S. Cembrowski and R. N. Carey Adding Value to Proficiency Testing Programs Clin. Chem., January 1, 2000; 46(1): 7 - 8. [Full Text] [PDF]
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C. M. Cobbaert and T. K. J. Luderer Total Error Evaluation of Roche Direct HDL-Cholesterol Reagent and Calibrator across 31 Lot Combinations: A 2-Year Experience Clin. Chem., January 1, 2000; 46(1): 133 - 134. [Full Text] [PDF]
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C. M. Pfeiffer, S. J. Smith, D. T. Miller, and E. W. Gunter Comparison of Serum and Plasma Methylmalonic Acid Measurements in 13 Laboratories: An International Study Clin. Chem., December 1, 1999; 45(12): 2236 - 2242. [Abstract] [Full Text] [PDF]
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C. M. Pfeiffer, D. L. Huff, S. J. Smith, D. T. Miller, and E. W. Gunter Comparison of Plasma Total Homocysteine Measurements in 14 Laboratories: An International Study Clin. Chem., August 1, 1999; 45(8): 1261 - 1268. [Abstract] [Full Text] [PDF]
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