Quality Requirements
Biological Variation Database reference list
Dr. Carmen Ricos and colleagues update this database on within-subject and between-subject biologic variation. From this data, they also calculate desirable specifications for imprecision, inaccuracy, and total allowable error. We are honored to be able to host this database. This article lists all of the references. Updated for 2014
Desirable Specifications for Total Error, Imprecision, and Bias, derived from Intra- and Inter-Individual Biologic Variation
This most recent and extensive listing of biologic goals has been provided by Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, Minchinela J, Perich C, Simon M. "Current databases on biologic variation: pros, cons and progress." Scand J Clin Lab Invest 1999;59:491-500. Updated references for 2001, 2004, 2006, 2008, 2010, 2012, and 2014 included.
Annex III: Articles used to elaborate the database of Within-subject and between-subject CV values of analytes and Analytical Quality Specifications for imprecision, bias and total error
1-10
11-20
21-30
31-40
41-50
51-60
61-70
71-80
81-90
91-100
101-110
111-120
121-130
131-140
141-150
151-160
161-169
170-182
183-188
189-198
199-214
215-229
230-247
See The Analytes and their References
See The Actual Numbers (specifications)
See The original Guest Essay
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41. Fogarty Y, Fraser CG, Browning MCK. Intra- and inter-individual variation of serum angiotensin converting enzyme:clinival implications.. Ann Clin Biochem 1989; 26: 201-202
42. Ford RP, Mitchell PEG, Fraser CG. Desirable performance characteristics and clinical utility of immunoglobulin and light-chain assays derived from data on biological variation. Clin Chem 1988; 34: 1733-1736.
43. Ford RP, Mitchell PEG, Fraser CG. The clinical utility of ??and ? light-chain assays: considerations from biological variation data . Ann Clin Biochem 1988;sp142S-143S
44. Ford RP. Essential data derived from biological variation for estableshment and use of lipid analyses.. Ann Clin Biochem 1989; 26: 281-285
45. Fraser CG, Hearne CR. Components of variance of some plasma constituents in patiens with myocardial infarction. Ann Clin Biochem 1982; 19:432-434
46. Fraser CG, Williams P . Short-term biological variation of plasma analytes in renal disease. Clin Chem 1983;29:508-510
47. Fraser CG, Hearne CR. Components of variance of some plasma constituents in patients with myocardial infarction. Ann Clin Biochem 1982;19: 431-434
48. Fraser CG, Wilkinson SP, Neville RG, Knox JDE, King JF, MacWalter RS. Biologic variation of common hematologic laboratory quantities in the elderly. Am J Clin Pathol 1989; 92: 465-470
49. Fraser Callum G., Cummings Steven T., Wilkinson Stephen P., Neville Ronald G., Knox James D. E., Ho Olga, and MacWalter Ronald S.. Biological variability of 26 clinical chemistry analytes in elderly people.. Clin Chem 1989; 35: 783-786
50. Friedlander Y, Kark JD and Stein Y. Variability ofPlasma Lipids and Lipoproteins: The jerusalem Lipid Research Clinic Study. Clin Chem 1985;31: 1121-1126
51. Gallacher RE, Browning MCK, Fraser CG, Wilkinson SP, MacLennan WJ. A method for simultaneously estimating plasma, erythrocyte and leukocyte sodium, potassium and magnesium: reference values and considerations from biological variation data. Clin Chem 1987; 33: 1326-1330
52. Gallagher SK, Johnson LK, and Milne DB. Short-term and long-term variability of indices related to nutritional status. I: Ca, Cu, Fe, Mg, and Zn.. Clin Chem 1989; 35: 369-373
53. Gallagher SK, Johnson AK, Milne DB. Short and long term variability of selected indices related to nutritional status. II. Vitamins, lipids, and protein indices.. Clin Chem 1992; 38: 1449-1453
54. Garg UC, Zheng ZJ, Folsom AR, Moyer YS, Tsai MY, McGovern P, Eckfeldt JH . Short-term and long-term variability of plasma homocysteine measurement.. Clin Chem 1997; 43: 141-145
55. Garnero P, Delmas PD. Variability and response of urinary resorption markers to hormone replacement therapy . J Bone MineralL Res 199;14:470-1
56. Gerdes AM, Hultoft Petersen P, Horder M, Bonnevie-Nielsen V.. Separate estimation of biological and analytical variance components when quantities and reagents are unstable.. Scand J Clin Lab Invest 1995; 55: 523-528
57. Giles L, Smicklas-Wright H, Fosmire G, Derr J. Variations in plasma zinc in older men and women. Biological Trace Element Research 1994; 41: 235-243
58. Gion M, Cappelli G, Mione R, Pistorello M, Meo S, Vignati G, Fortunato A, Saracchini S, Biasioli R, Giulisano M . Evaluation of critical differences of CEA and CA 15.3 levels in serial samples from patients operated for breast cancer. Int J Biol Markers 1994; 9:135-139
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60. Godslang IF. Intra-individual variation: significant changes in parameters of lipid and carbohydrate metabolism in the individual andintra-individual variation in different test populations. Ann Clin Biochem 1985; 22: 618:624
61. González-Revaldería J., García-Bermejo S., Menchén-Herreros A., and Fernández-Rodriguez E.. Biological variation of Zn, Cu, and Mg in serum of healthy subjects.. Clin Chem 1990; 36:2140-2141
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63. Gowans EMS, Fraser CG. Biological variation in analyte concentrations in urine of apparently healthy men and women. Clin Chem 1987; 33: 847-850
64. Gowans EMS, Fraser G. Longer-term biological variation of commonly analyzed serum constituents. Clin Chem 1987;33: 717.
65. Gowans EMS, Fraser CG. Biological variation of serum and urine creatinine and creatinine clearance: ramifications for interpretation of results and patient care. Ann Clin Biochem 1988;25: 259-263
66. Gowans MS, FraserCG. Do biologica- variation data shed light on the demise of some historical indices used to assess calcium homeostasis?. Clin Chem 1987;33:1267-1268
67. Hannon R, Blumsohn A, Naylor K, Eastell R. Response of biochemical markers of bone turnover to hormone replacement therapy: impact of biological variability. J Bone & Mineral Res 1998;13:1124-33
68. Harding PJ, Fraser CG. Biological variation of blood acid-base status: Consequences for analytical goal-setting and interpretation of results. Clin Chem 1987;33:1416-1418
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73. Hölzel WGE. Intra-individual variation of some analytes in serum of patients with chronic renal failure. Clin Chem 1987; 33:670-673.
74. Hölzel WGE. Influence of hypertension and antihypertensive drugs on the biological intra-individual variation of electrolytes and lipids in serum. Clin Chem 1988; 34: 1485-1488.
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Note from the authors: Reference 113 has been eliminated.