INTRA- AND INTER-INDIVIDUAL BIOLOGICAL VARIABILITY DATA BANK: REFERENCES

María Ángeles Sebastián-Gámbaro, Francisco Javier Lirón-Hernández, Xavier Fuentes-Arderiu Servei de Bioquímica Clínica Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Barcelona, Spain

Correspondence: Dr. X. Fuentes Arderiu Servei de Bioquímica Clínica Ciutat Sanitària i Universitària de Bellvitge 08907 L'Hospitalet de Llobregat Barcelona, Spain

Intra- and Inter-Individual Biological Variability Data Bank, Page 1
Intra- and Inter-Individual Biological Variability Data Bank, Page 2
Serum-a-Acid glycoprotein; r through Serum-a-Amylase; b
Urine(morning)-a-Amylase; b through Serum-Bilirubin esterfied; c
Serum-C peptide; c through Serum-Cholesterol; c
Serum-Cholinesterase; b through Serum-Cysteine; c
Serum-Dehydroespiandrosterone sulfate; c through Leukocytes-Granulocytes; d
Serum-Haptoglobin; c through Serum-17-Hydroxyprogesterone; c
Serum-Immunoglobulin A; r through Serum-LDL-Cholesterol; c
Blood-Leukocytes; C through Urine(morning)-Magnesium(II); c
Serum-Peptidil-dipeptidase A: b through Urine(random)-Potassium ion: c
Serum-b₂-Microglobulin: r through Urine(random)-Oxalate; c
Serum-Prealbumin; c through Serum-Pyruvate; c
Serum-Retinol; c through Urine(random)-Sodium ion; c
Serum-Superoxide dismutase; b through Serum-Triiodothyronine (non protein bound); c
Serum-Urate; c through Serum-Zinc(II); c
References
CLIA Requirements
Clinical Quality Requirements.
European Calculated Biologic Allowable Total Errors

The References

1. Fraser CG. Analytical goals in clinical biochemistry. In: Stefanini M, Benson ES, eds. Progress in Clinical Pathology, Vol III. New York: Grune & Stratton, 1981.
2. Fraser CG, Harris EK. Generation and aplication of data on biological variation in clinical chemistry. Crit Rev Clin Lab Sci 1989; 27: 409-37.
3. Fraser CG, Hyltoft Petersen P. The importance of imprecision. Ann Clin Biochem 1991; 28: 207-11.
4. Fraser CG, Hyltoft Petersen P. Quality goals in external quality assessment are best based on biology. Scand J Clin Lab Invest 1993; 212 Suppl 53: 8-9.
5. Harris EK. Proposed goals for analytical precision and accuracy in single-point diagnostic testing. Arch Pathol Lab Med 1988; 112: 416-20.
6. Westgard JO, Seehafer JJ and Barry PL. Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria. Clin Chem 1994; 40: 1909-14.
7. Liappis N, Fuchs R, Reimnitz P. Physiologische Schwankungen der Konzentrationen von Gesamteiweib, Transferrin, Haptoglobin, Saurem a1-Glykoprotein, a2-Makroglobulin, Properdin Faktor B, C3-Komplement, C4-Komplement, IgA, IgG, IgM, a1-Antitrypsin und Coeruloplasmin in Nüchternserum gesunder Männer. Ärztl Lab 1986; 32: 286-92.
8. Clark GH, Fraser CG. Biological variation of acute phase proteins. Ann Clin Biochem 1993; 30: 373-6.
9. Franzini C, Scapellato L, Vanoni G. Variabilità biologica de analitica della anti-sttreptolisina O e di proteine della fase acuta del siero. Biochemica Clinica 1993; 17:315-319.
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12. Panteghini M, Pagani F. Biological variation in bone-derived biochemical markers in serum. Scand J Clin Lab Invest. 1995; 55: 609-16.
13. Juan-Pereira L. Variabilitat biològica intraindividual de les magnituds bioquímiques. Aplicacions clíniques. Tesis doctoral. Barcelona: Universitat Autònoma de Barcelona, 1989.
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15. Costongs GMPJ. Janson PCW, Bas BM, et al: Short-term and long-term intra-individual variations and critical differences of clinical chemical laboratory parameters. J Clin Chem Clin Biochem 1985; 23: 7-16.
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28. Gowans EMS, Fraser CG: Longer-term biological variation of commonly analyzed serum constituents. Clin Chem 1987; 33:717.
29. Juan-Pereira L, Fuentes-Arderiu X. Intraindividual variation of the electroforetic serum protein fractions. Clin Chem 1989; 35: 1544.
30. Howey JEA, Browing MCK, Fraser CG. Selecting the optimun specimen for assessing slight albuminuria, and a strategy for clinical investigation: novel uses of data on biological variation. Clin Chem 1987; 33: 2034-8.
31. Mella M, Salamone A, Spagliardi G, Stella P, Guagnellini E. Reference values and biological variation for albumin, alfa-1-microglobulin and beta-2-microglobulin in urine specimens. Biochem Clin 1989; 13 Suppl: 89.
32. Ricós C, Arbós MA. Quality goals for hormone testing. Ann Clin Biochem 1990; 27: 353-8.
33. Gallager SK, Johnson LK, Milne DB. Short-term and long-term variability of indices related to nutricional status, I: Ca, Cu, Fe, Mg, and Zn. Clin Chem 1989; 35: 369-73.
34. Beck Jensen JE, Sfrensen HA, Kollerup G, Jensen LB, Sfrensen OH. Biological variation of biochemical bone markers. Scand J Clin Lab Invest 1994; 54 Suppl 219: 36-9.
35. Winkel P, Statland BE. Correlation of selected serum constituents: Consistency of intra-individual correlation values, means and variances during four months. Clin Chem 1976; 22: 1855-61.
36. Hölzel WGE: Intra-individual variation of some analytes in serum of patients with chronic renal failure. Clin Chem 1987; 33: 670-3.
37. Williams GZ, Widdowson GM, Penton J. Individual character of variation in time-series studies of healthy people. II. Differences in values for clinical chemical analytes in serum among demographic groups, by age and sex. Clin Chem 1978; 24: 313-20.
38. Browing MCK, Mcfarlane NP. Objective interpretation of results for tumour markers. J Nucl Med Allied Sci 1990; 34 Suppl: 89-91.
39. Bingham SA, Williams R, Cole TJ, Price CP, Cummings JH. Reference values for analytes of 24-hour urine collections. Ann Clin Bioche 1988; 25: 610-9.
40. Boyle CE, Cummings ST. Fraser CG: Amylase versus lipase activity assays: Considerations from biological variation. Ann Clin Biochem 1987; 24 Suppl 1: 37-8.
41. Cummings ST, Fraser CG. Total amylase and pancreatic isoamylase in serum and urine: considerations from data on biological variation. Ann Clin Bioche 1989; 26: 335-40.
42. Huguet J, Fuentes-Arderiu X. Biological variation in the catalytic concentration of pancreatic a-amilase and triacylglicerol lipase in serum. Scand J Clin Lab Invest. 1991; 51: 735-8.
43. Ricós C, Jiménez CV, Hernández A, Simón M, Perich C, Alvarez V, Minchinela J, Maciá M. Biological variation in urine samples used for analyte measurements. Clin Chem 1994; 40: 472-7.
44. Wasenius A, Stugaard M, Otterstad JE, Froyshov D. Diurnal and monthly intra-individual variability of the concentration of lipids, lipoproteins and apoproteins. Scand J Clin Lab Invest 1990; 50: 635-42.
45. Rivera-Coll A, Fuentes-Arderiu X, Diez-Noguera A. Circadian rhythmic variations in serum concentrations of clinically important lipids. Clin Chem 1994; 40: 1549-53.
46. Marcovina SM, Gaur VP, Albers JJ. Biological variability of cholesterol, triglyceride, low- and high-density lipoprotein cholesterol, lipoprotein(a), and apolipoproteins A-I and B. Clin Chem 1994; 40: 574-8.
47. Ford RP: Essential data derived from biological variation for establishment and use of lipid analyses. Ann Clin Biochem 1989; 26: 281-5.
48. Maes M, Weeckx S, Wauters A, Neels H, Scharpé S, Verkerk R, Demedts P, Desnyder R. Biological variability in serum vitamin E concentrations: relation to serum lipids. Clin Chem 1996; 42: 1824-31.
49. Ortolá J, Castiñeiras MJ, Fuentes-Arderiu X. Biological variation data applied to the selection of serum lipid ratios used as risk markers of coronary heart disease. Clin Chem 1992; 38: 56-9.
50. Brown SA, Boerwinkle E, Kashanian FK, Swanson N, Patsch W. Variations in concentrations of lipids, lipoprotein lipids, and apolipoproteins A-I and B in plasma from healthy women. Clin Chem 1990; 36: 207-10.
51. Chambless LE, McMahon RP, Brown SA, Patsch W, Heiss G, Shen Y. Short-term Intraindividual Variability in Lipoprotein Measuraments: Atheriosclerosis Risk in Communities (ARIC) Study.Am J of Epidemiol. 1992; 136:1069-1080
52. Hörder M, Bowers GN, Biological variability in aspartate aminotransferase activity in serum of healthy persons, and effect of in vitro supplementation with pyridoxal 5-phosphate. Clin Chem 1977; 23: 551-4.
53. Dot D, Miró J, Fuentes-Arderiu X. Biological variation of the leukocyte differential count quantities. Scand J Clin Invest 1992; 52: 607-11.
54. Jiménez C, López R. Variación biológica y objetivo de calidad analítica para el factor reumatoide y la proteína C reactiva. Quím Clín 1992; 11: 321.
55. Browning MCK: Biological variation of the breast tumour marker CA 15-3: Implications for necessary standards of performance and the interpretation of results. Ann Clin Biochem 1987; 24 Suppl 1: 35-6.
56. Sölétormos G, Schifler V, Nielsen D, Skovsgaard T, Dombernowsky P. Interpretation of results for tumor markers on the basis of analytical imprecision and biological variation. Clin Chem 1993; 39: 2077-83.
57. Gowans EMG, Fraser CG. Do biological variation data shed light on the demise of some historical indices used to assess calcium homeostasis? Clin Chem 1987; 33: 1267-8.
58. Eckfeldt JH, Chambles LE, Shen Y. Short-term, Within-person Variability in Clinical Chemistry Test Results. Arch Pathol Lab Med 1994; 118:496-500
59. Shephard MSD, Penberthy LA, Fraser CG: Short-and-long-term biological variation in analytes in urine of apparently healthy individuals. Clin Chem 1981; 33: 1326-30.
60. Gowans EMS, Fraser CG: Biological variation in analyte concentrations in urine of apparently healthy men and women. Clin Chem 1987; 33: 847-50.
61. Harding PJ, Fraser CG: Biological variation of blood acid-base status: Consequences for analytical goal-setting and interpretation of results. Clin Chem 1987; 33: 1416-8.
62. Brookstein L, Gidding SS, Donovan M, Smith FA. Day-to-day variability of serum cholesterol, triglyceride and high-density lipoprotein cholesterol levels. Arch Intern Med 1990; 150: 1653-7.
63. Mogadam M, Ahmed SW, Mensch AH, Godwin ID. Within-person fluctuations of serum cholesterol and lipoproteins. Arch Intern Med 1990; 150: 1645-8.
64. Aguzzi F, Poggi N, Maggi M. Some data on intra-individual variability in high-density-lipoprotein cholesterol. Clin Chem 1979; 25: 1671.
65. Friedlander Y, Kark JD, Stein Y. Variability of plasma lipids and lipoproteins: The Jerusalem lipid research clinic study. Clin Chem 1985; 31: 1121-6.
66. Godsland I. Intra-individual variation: significant changes in parameters of lipid and carbohydrate metabolism in the individual and intra-individual variation in diferent test populations. Ann Clin Biochem 1985; 22: 618-24.
67. Demacker PNM, Schade RWB, Jansen RTP, Van't Laar A. Intra-individual variation of serum cholesterol, triglycerides and high density lipoprotein cholesterol in normal men. Atherosclerosis 1982; 45: 259-66.
68. Kafonek SD, Donovan L, Lovejoy KL, Bachorik PS. Biological variation of lipids and lipoproteins in fingerstick blood. Clin Chem 1996; 42: 2002-7.
69. Mjös OD, Rao SN, Björul, Henden T, Thelle DS, Förde OH, Miller NE. A longitudinal study of the biological variability of plasma lipoproteins in healthy young adults. Atherosclerosis 1979; 34: 75-81.
70. Thompson SG, Pocock SJ. The variability of serum cholesterol measurements: implications for screening and monitoring. J Clin Epidemiol 1990; 43: 783-9.
71. Choudhury N, Lyons Wall PM, Stewart Truswell A. Effect of Time Between Measuraments on Within-Subject Variability for Total Cholesterol and High-Density Lipoprotein Cholesterol in Women. Clin Chem 1994: 40:710-715
72. Sidell FR, Kaminskis SA. Temporal intrapersonal physiological variability of cholinesterase activity in human plasma and erytrocytes. Clin Chem 1975; 21: 1961-3.
73. Callaway S, Davies DR, Rutland JP. Blood cholinesterase levels and range of personal variation in a healthy adult population. Br Med J 1951; 2: 812-5.
74. Moses GC, Tuckerman JF. Henderson AR: Biological variance of cholinesterase and 5'-nucleotidase in serum of healthy persons. Clin Chem 1986; 32: 175-7.
75. Wetstone HJ, LaMotta RV. The clinical stability of serum cholinesterase activity. Clin Chem 1965; 11: 653-63.
76. Brock A. Immunoreactive plasma cholinesterasa (EC 3.1.1.8) substance concentration, compared with cholinesterase activity concentration and albumin: inter- and intra-individual variations in a healthy population group. J Clin Chem Clin Bioche 1990; 28: 851-6.
77. López R, Planells P, Juvé R, Jiménez CV, Cervera M, Navarro JM. Variabilidad biológica de la concentración de anticuerpos frente al virus de la rubeola y el citomegalovirus. Quím Clín 1992; 11: 287.
78. Dot D, Miró J, Fuentes-Arderiu X. Within-Subject and between-subject biological variation of prothrombin time and activated partial thromboplastin time. Ann Clin Biochem 1992; 29: 422-5.
79. Gonzales-Revaldería J, García-Bermejo S, Menchen-Herreros A, Fernández-Rodríguez E. Biological variation of Zn, Cu and Mg in serum of healthy subjects. Clin Chem 1990; 36: 2140-2.
80. Rosano TG, Brown HH: Analytical and biological variability of serum creatinine and creatinine clearance: Implications for clinical interpretation. Clin Chem 1982; 28: 2330-1.
81. Richie JP, Abraham P, Leutzinger Y. Long-term stability of blood glutathione and cysteine in humans. Clin Chem 1996; 42:1100-1105.
82. Fraser CG,Wilkinson SP, Neville RG et al .Biologic Variation of Common Hematologic Laboratory Quantities in the Elderly. Am J Clin Pathol 1989; 92:465-470.
83. Borel MJ, Smith SM, Derr J, Beard JL. Day-to-day variation in iron-status indices in healthy men and women. Am J Clin Nutr 1991; 54: 729-35.
84. Fuentes-Arderiu, Albert P. Within-subject biological variation of pituitary-ovarian axis hormones and desirable imprecision. Clin Chem Acta 1992; 207: 257-9.
85. Valero-Politi J, Estudio de la variabilidad biológica de algunas magnitudes relacionadas con la función androgénica masculina. Tesis doctoral. Barcelona: Universitat Autònoma de Barcelona, 1994.
86. Valero-Politi J, Fuentes-Arderiu X. Within- and between-subject biological variations of follitropin, lutropin, testosterone, and sex-hormone-binding globulin in men. Clin Chem 1993; 39: 1723-5.
87. Davie SJ, Whiting KL, Gould BJ. Biological variation in glycated proteins. Ann Clin Biochem 1993; 30: 260-4.
88. Howey JEA, Browing MCK, Fraser CG. Assay of serum fructosamine minimizing standarization and matrix problems: Use to assess components of biological variation. Clin Chem 1987; 33: 269-72.
89. Cummings ST, Fraser CG. Variability of capillary plasma glucose in healthy individuals in repeated 75-g oral glucose tolerance tests. Ann Clin Biochem 1988; 26: 634-7.
90. Maes M, Cooreman W, Delanghe J, Scharpé S, Wauters A, Neels H, D´Hondt P, Peeters D, Cosyns P, Ranjan R, Bosmans E, DeMeyer F, Elkis H, Desnyder R. Components of Biological variation in plasma haptoglobin: relationships to plasma fibrinogen and immune variables, including interleukin-6 and its receptor. Clin Chim Acta 1995; 239: 23-35.
91. Ford RP, Mitchell PEG, Fraser CG. Desirable performance characteristics and chinical utility of immunoglobulin and light-chain assays derived from data on biological variation. Clin Chem 1988; 35: 783-6
92. Statland BE, Winkel P. Relationship of day-to-day variation of serum iron concentration to iron-binding capacity in healthy young women. Am J Clin Pathol 1977; 67: 84-90.
93. Panteghini M, Pagani F. Biological variation of lactate and pyruvate in blood. Clin Chem 1993; 39: 908.
94. Moses GC, Henderson AR: Biological variance of total lactate dehydrogenase and its isoenzymes in human serum. Clin Chem 1984; 30: 1737-41.
95. Stanland LP, Harris SC, Burdsall MJ, Saunders AM. Evaluatión of biologic sources of variation of leukocyte counts and other hematologic quantities using very precise automated analyzers. Am J Clin Pathol 1977; 69: 48-54.
96. Constongs GMPJ, Janson PCW, Bas BM, et al. Short-term and long-term intra-individual variations and critical differences of haematological laboratory parameters. J Clin Chem Clin Biochem 1985; 23: 69-76.
97. Panteghini M, Pagani F. Pre-analytical, analytical and biological sources of variation of lipoprotein(a). Clin Chem Clin Biochem 1993; 31: 23-8.
98. Whiting MJ, Williams P, Tallis GA. Biological variability of plasma lipoprotein(a) over a one year period. Clin Biochem Revs 1996; 17: 98
99. Gallacher RE, Browing MCK, Fraser CG, et al: A method for simultaneously estimating plasma, erytrocyte, and leukocyte sodium, potasium and magnesium: Reference values and considerations from biological variation data. Clin Chem 1987; 33: 1326-30.
100. Elin R, Hoseini JM, Ruddel M. Intra-individual variability of blood magnesium parameters with time. Ann Clin Biochem 1989; 35: 1114-5.
101. Djurhuus MS, Gram J, Hyltoft Petersen P, Klitgaard NAH, Bollerslev J, Beck-nielsen H. Biological variation of serum and urinary magnesium in apparently healthy males. Scand J Clin Invest 1995; 55: 549-58.
102. Nicoll GW, Strthers AD, Fraser CG. Biological variation of urinary magnesium. Clin Chem 1991; 37: 1794-5.
103. Browning MCK, McFarlane NP, Horobin J, Preece PE, Wood RAB. Evaluation of the comparative clinical utility of CA 15.3 and mucinous carcinoma-associated antigen (MCA) in the management of breast carcinoma. Ann Clin Biochem 1988; 25 Suppl: 54s-6s.
104. Balchin ZEC, Moss PA, Fraser CG. Biological variation of urinary oxalate in different specimen types. Ann Clin Biochem 1991; 28: 622-3.
105. Fogarty Y, Fraser CG, Browing MCK. Intra- and inter-individual variation of serum angiotensin converting enzyme: clinical implications. Ann Clin Biochem 1989; 26: 201-2.
106. Ortolá J, Fuentes-Arderiu X. Intra- and inter-individual biological variation of the serum concentration of phospholipids. Clin Chem 1991; 37: 583.
107. Penev M N, Duvkova-Penev P, Kalinov K. Study on long term biological variability of erytrocyte sedimentation rate. Scand J Clin Lab Invest 1996; 56: 285-8.
108. Jahan A, Browing MCK, Fraser CG. desirable performance standards for assays of serum water and osmolarity. Clin Chem 1988; 34: 995.
109. Browning MCK, Ford RP, Callagham SJ, et al. Intra- and interindividual biological variation of five analytes used in the asseasment of thyroid function: Implications for necessary standards of performance and the interpretation of results. Clin Chem 1986; 32: 962-6.
110. Polo-Polo MJ, Ricós-Aguilá C, Catalán-Gili R, Juvany-Roig R. Aplicación clínica de los datos de variación biológica de las hormonas tiroideas. Med Clin 1992; 99: 529-31.
111. Hözlel WGE, Deschner W. Intra-individual variation of serum thyroxine and triiodothyronine in pregnancy. Clin Chem 1988; 34: 2063-5.
112. Juan-Pereira L, Navarro MA, Roca M, Fuentes-Arderiu X. Within-subject variation of thiroxine and tri-iodothyronine concentrations in serum. Clin Chem 1991; 37: 772-3.
113. López R, Planells P, Juvé R, Jiménez CV, Cervera M, Navarro JM. Variabilidad biológica de la concentración sérica de anticuerpos frente al Toxoplasma gondii. Quím Clín 1992; 11: 285.
114. Ross JW. Evaluation of precision. In: Werner M, de. Handbook of Clinical Chemistry, Vol. 1. Boca Raton: CRC Press, 1982:391-422.
115. Fraser CG. The application of theoretical goals based on biological variation data in proficiency testing. Arch Pathol Lab Med 1988; 112: 404-415.
116. Fraser CG. Biological variation in clinical chemistry. Arch Pathol Lab Med 1992; 116: 916-923.

Intra- and Inter-Individual Biological Variability Data Bank, Page 1
Intra- and Inter-Individual Biological Variability Data Bank, Page 2
Serum-a-Acid glycoprotein; r through Serum-a-Amylase; b
Urine(morning)-a-Amylase; b through Serum-Bilirubin esterfied; c
Serum-C peptide; c through Serum-Cholesterol; c
Serum-Cholinesterase; b through Serum-Cysteine; c
Serum-Dehydroespiandrosterone sulfate; c through Leukocytes-Granulocytes; d
Serum-Haptoglobin; c through Serum-17-Hydroxyprogesterone; c
Serum-Immunoglobulin A; r through Serum-LDL-Cholesterol; c
Blood-Leukocytes; C through Urine(morning)-Magnesium(II); c
Serum-Peptidil-dipeptidase A: b through Urine(random)-Potassium ion: c
Serum-b₂-Microglobulin: r through Urine(random)-Oxalate; c
Serum-Prealbumin; c through Serum-Pyruvate; c
Serum-Retinol; c through Urine(random)-Sodium ion; c
Serum-Superoxide dismutase; b through Serum-Triiodothyronine (non protein bound); c
Serum-Urate; c through Serum-Zinc(II); c
References
CLIA Quality Requirements
Clinical Quality Requirements.
European Calculated Biologic Allowable Total Errors