Reference distributions for apolipoproteins AI and B and B/AI ratios: Comparison of a large cohort to the world's literature

Journal of Clinical Laboratory Analysis

Volumn 20, Issue 5, 2006, Pages 218-226

  Ritchie, Robert F ^a   Palomaki, Glenn E ^a   Neveux, Louis M ^a   Ledue, Thomas B ^a   Marcovina, Santica ^b   Navolotskaia, Olga ^c  

^a FOUNDATION FOR BLOOD RESEARCH   (United States)

^b UNIVERSITY OF WASHINGTON   (United States)

^c LERNER RESEARCH INSTITUTE   (United States)

Author keywords

Apolipoprotein AI; Apolipoprotein B; Apolipoprotein B AI ratio; Caucasian; Reference intervals; SP1 01; SP3 07

Indexed keywords

APOLIPOPROTEIN A1; APOLIPOPROTEIN B;

ADOLESCENT; ADULT; AGED; ARTICLE; ATHEROSCLEROSIS; CARDIOVASCULAR DISEASE; CAUCASIAN; CHILD; COHORT ANALYSIS; ETHNIC GROUP; FEMALE; HUMAN; INFANT; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; PROTEIN BLOOD LEVEL; RACE DIFFERENCE; REFERENCE VALUE;

AGE DISTRIBUTION; APOLIPOPROTEIN A-I; APOLIPOPROTEINS B; COHORT STUDIES; ETHNIC GROUPS; HUMANS; REFERENCE STANDARDS;

EID: 33748785744     PISSN: 08878013     EISSN: 10982825     Source Type: Journal    
DOI: 10.1002/jcla.20135     Document Type: Article

References (102)

1. Ritchie RF, Palomaki GE, Neveux LM, Navolotskaia O. Reference distributions for immunoglobulins A, G, and M: a comparison of a large cohort to the world's literature. J Clin Lab Anal 1998;12:371-377.
2. Ritchie RF, Palomaki GE, Neveux LM, Navolotskaia O. Reference distributions for the negative acute-phase proteins, albumin, transferrin, and transthyretin: a comparison of a large cohort to the world's literature. J Clin Lab Anal 1999;13:280-286.
3. Ritchie RF, Palomaki GE, Neveux LM, Navolotskaia O. Reference distributions for the positive acute phase proteins, alpha1-acid glycoprotein (orosomucoid), alpha1-antitrypsin, and haptoglobin: a comparison of a large cohort to the world's literature. J Clin Lab Anal 2000;14:265-270.
4. Ritchie RF, Palomaki GE, Neveux LM, Navolotskaia O. Reference distributions for complement proteins C3 and C4: a comparison of a large cohort to the world's literature. J Clin Lab Anal 2004;18:9-13.
5. Ritchie RF, Palomaki GE, Neveux LM, Navolotskaia O, Ledue TB, Craig WY. Reference distributions for serum iron and transferrin saturation: a comparison of a large cohort to the world's literature. J Clin Lab Anal 2002;16:246-252.
6. Ritchie RF, Palomaki GE, Neveux LM, Navolotskaia O. Reference distributions for alpha2-macroglobulin: a comparison of a large cohort to the world's literature. J Clin Lab Anal 2004;18:148-152.
7. Albers JJ, Wahl PW, Cabana VG, Hazzard WR, Hoover JJ. Quantitation of apolipoprotein A-I of human plasma high density lipoprotein. Metabolism 1976;25:633-644.
8. Cheung MC, Albers JJ. 1977. The measurement of apolipoprotein A-I and A-II levels in men and women by immunoassay. J Clin Invest 1977;60:43-50.
9. Dedonder-Decoopman E, Fievet-Desreumaux C, Campos E, et al. Plasma levels of VLDL-+LDL-cholesterol, HDL-cholesterol, triglycerides and apoproteins B and A-I in a healthy population-influence of several risk factors. Atherosclerosis 1980;37:559-568.
10. Fager G, Wiklund O, Olofsson SO, Wilhelmsson C, Bondjers G. 1980. Serum apolipoprotein levels in relation to acute myocardial infarction and its risk factors. Apolipoprotein A-I levels in male survivors of myocardial infarction. Atherosclerosis 1980;36:67-74.
11. Ballantyne FC, Clark RS, Simpson HS, Ballantyne D. 1982. High density and low density lipoprotein subfractions in survivors of myocardial infarction and in control subjects. Metabolism 1982;31:433-437.
12. Maciejko JJ, Holmes DR, Kottke BA, Zinsmeister AR, Dinh DM, Mao SJ. 1983. Apolipoprotein A-I as a marker of angiographically assessed coronary-artery disease. N Engl J Med 1983;309:385-389.
13. Schaefer JR, Rader DJ, Ikewaki K, et al. In vivo metabolism of apolipoprotein A-I in a patient with homozygous familial hypercholesterolemia. Arterioscler Thromb 1992;12:843-848.
14. Alvarez C, Orejas A, Gonzalez S, Diaz R, Colomo LF. Reference intervals for serum lipids, lipoproteins, and apoproteins in the elderly. Clin Chem 1984;30:404-406.
15. Goldstein S, Duhamel G, Laudat MH, et al. Plasma lipids, lipoproteins and apolipoproteins AI, AII, and B in renal transplanted children: what risk for accelerated atherosclerosis? Nephron 1984;38:87-92.
16. Vander Heiden GL, Barboriak JJ, Sasse EA, Yorde DE. Correlation of the extent of coronary occlusion with Apo B levels. Application of a new enzyme immunoassay technique for Apo B. Atherosclerosis 1984;50:29-33.
17. De Backer G, Hulstaert F, De Munck K, Rosseneu M, Van Parijs L, Dramaix M. Serum lipids and apoproteins in students whose parents suffered prematurely from a myocardial infarction. Am Heart J 1986;112:478-484.
18. Freedman DS, Srinivasan SR, Shear CL, Franklin FA, Webber LS, Berenson GS. The relation of apolipoproteins A-I and B in children to parental myocardial infarction. N Engl J Med 1986;315:721-726.
19. Rifai N, King ME. Immunoturbidimetric assays of apolipoproteins A, AI, AII, and B in serum. Clin Chem 1986;32:957-961.
20. Desoye G, Schweditsch MO, Pfeiffer KP, Zechner R, Kostner GM. Correlation of hormones with lipid and lipoprotein levels during normal pregnancy and postpartum. J Clin Endocrinol Metab 1987;64:704-712.
21. Ordovas JM, Peterson JP, Santaniello P, Cohn JS, Wilson PW, Schaefer EJ. Enzyme-linked immunosorbent assay for human plasma apolipoprotein B. J Lipid Res 1987;28:1216-1224.
22. Perova N, Aingorn H, Metelskaya V, Dorofeeva T, Belokonj N. Plasma lipid and apolipoprotein levels in children hereditarily predisposed to coronary heart disease. Acta Paediatr Scand 1988;77:559-562.
23. Schwartz KE, Zaro B, Burton P, Hunt J, Pennelly L, Sevelius H. Reduction of serum lipoproteins in man by the oral administration of a prostaglandin analogue (enprostil). Atherosclerosis 1988;71:9-16.
24. Bagdade JD, Subbaiah PV. Whole-plasma and high-density lipoprotein subfraction surface lipid composition in IDDM men. Diabetes 1989;38:1226-1230.
25. Ford RP. Essential data derived from biological variation for establishment and use of lipid analyses. Ann Clin Biochem 1989;26(Pt 3):281-285.
26. Lamon-Fava S, Fisher EC, Nelson ME, et al. Effect of exercise and menstrual cycle status on plasma lipids, low density lipoprotein particle size, and apolipoproteins. J Clin Endocrinol Metab 1989;68:17-21.
27. Dean JD, Owens DR, Matthews SB. Apolipoprotein and lipid ratios in treated non-insulin dependent diabetics. Diabetes Res 1990;15:21-25.
28. Kawanishi M, Nakamoto A, Konemori G, Horiuchi I, Kajiyama G. Coronary sclerosis risk factors in males with special reference to lipoproteins and apoproteins: establishing an index. Hiroshima J Med Sci 1990;39:61-64.
29. Schwartzkopff W, Schleicher J, Pottins I, Yu SB, Han CZ, Du DY. Lipids, lipoproteins, apolipoproteins, and other risk factors in Chinese men and women with and without myocardial infarction. Atherosclerosis 1990;82:253-259.
30. Wang XL, Wilcken DE, Dudman NP. Neonatal apo A-I, apo B, and apo(a) levels in dried blood spots in an Australian population. Pediatr Res 1990;28:496-501.
31. Averna MR, Barbagallo CM, Di Paola G, et al. Lipids, lipoproteins and apolipoproteins AI, AII, B, CII, CIII and E in newborns. Biol Neonate 1991;60:187-192.
32. Lussier-Cacan S, Xhignesse M, Desmarais JL, Davignon J, Kafrissen ME, Chapdelaine A. Cyclic fluctuations in human serum lipid and apolipoprotein levels during the normal menstrual cycle: comparison with changes occurring during oral contraceptive therapy. Metabolism 1991;40:849-854.
33. Buring JE, O'Connor GT, Goldhaber SZ, et al. Decreased HDL2 and HDL3 cholesterol, Apo A-I and Apo A-II, and increased risk of myocardial infarction. Circulation 1992;85:22-29.
34. Campos H, Genest JJ Jr, Blijlevens E, et al. Low density lipoprotein particle size and coronary artery disease. Arterioscler Thromb 1992;12:187-195.
35. O'Kane MJ, Wisdom GB, McEneny J, McFerran NV, Trimble ER. Pre-beta high-density lipoprotein determined by immunoblotting with chemiluminescent detection. Clin Chem 1992;38:2273-2277.
36. Parra HJ, Arveiler D, Evans AE, et al. A case-control study of lipoprotein particles in two populations at contrasting risk for coronary heart disease. The ECTIM Study. Arterioscler Thromb 1992;12:701-707.
37. Zunic G, Jelic-Ivanovic Z, Spasic S, Stojiljkovic A, Majkic-Singh N. Reference values for apolipoproteins A-I and B in healthy subjects, by age. Clin Chem 1992;38:566-569.
38. Brown SA, Morrisett JD, Boerwinkle E, Hutchinson R, Patsch W. The relation of lipoprotein[a] concentrations and apolipoprotein[a] phenotypes with asymptomatic atherosclerosis in subjects of the Atherosclerosis Risk in Communities (ARIC) Study. Arterioscler Thromb 1993;13:1558-1566.
39. Calabresi L, Meng QH, Castro GR, Marcel YL. Apolipoprotein A-I conformation in discoidal particles: evidence for alternate structures. Biochemistry 1993;32:6477-6484.
40. Couper JJ, Bates DJ, Cocciolone R, et al. Association of lipoprotein(a) with puberty in IDDM. Diabetes Care 1993;16:869-873.
41. Genest J Jr, Bard JM, Fruchart JC, Ordovas JM, Schaefer EJ. Familial hypoalphalipoproteinemia in premature coronary artery disease. Arterioscler Thromb 1993;13:1728-1737.
42. Marquez A, Mendoza S, Carrasco H, Hamer T, Glueck CJ. High lipoprotein(a) in children from kindreds with parental premature myocardial infarction. Pediatr Res 1993;34:670-674.
43. Shirai K, Nu T, Imamura M, et al. Low serum apolipoprotein A-I level in patients with vasospastic angina. Am Heart J 1993;125(Pt 1):320-323.
44. Silliman K, Tall AR, Kretchmer N, Forte TM. Unusual high-density lipoprotein subclass distribution during late pregnancy. Metabolism 1993;42:1592-1599.
45. Vega GL, Grundy SM. Two patterns of LDL metabolism in normotriglyceridemic patients with hypoalphalipoproteinemia. Arterioscler Thromb 1993;13:579-589.
46. Oyelola OO. Fasting plasma lipids, lipoproteins and apolipoproteins in Nigerian women using combined oral and progestin-only injectable contraceptives. Contraception 1993;47:445-454.
47. Barakat HA, Mooney N, O'Brien K, et al. Coronary heart disease risk factors in morbidly obese women with normal glucose tolerance. Diabetes Care 1993;16:144-149.
48. Doucet C, Huby T, Chapman J, Thillet J. Lipoprotein[a] in the chimpanzee: relationship of apo[a] phenotype to elevated plasma Lp[a] levels. J Lipid Res 1994;35:263-270.
49. Eugui J, Logrono MJ, Ruiz R, Zugaza C, Mirabel JL, Martinez C. Immunoturbidimetry of serum apolipoproteins A-I and B on the Cobas Bio centrifugal analyzer: method validation and reference values. Clin Biochem 1994;27:310-315.
50. Marzullo C, Michotey O, Bourderont D, et al. Comparative study of lipids, apoproteins and lipoproteins in patients with coronary disease and in a control population. Ann Biol Clin (Paris) 1994;52:717-720.
51. Montali A, Vega GL, Grundy SM. Concentrations of apolipoprotein A-I-containing particles in patients with hypoalphalipoproteinemia. Arterioscler Thromb 1994;14:511-517.
52. Rivera-Coll A, Fuentes-Arderiu X, Diez-Noguera A. Circadian rhythmic variations in serum concentrations of clinically important lipids. Clin Chem 1994;40:1549-1553.
53. Ruotolo G, Parlavecchia M, Taskinen MR, et al. Normalization of lipoprotein composition by intraperitoneal insulin in IDDM. Role of increased hepatic lipase activity. Diabetes Care 1994;17:6-12.
54. Leino A, Impivaara O, Kaitsaari M, Jarvisalo J. Serum concentrations of apolipoprotein A-I, apolipoprotein B, and lipoprotein(a) in a population sample. Clin Chem 1995;41:1633-1636.
55. Bastida S, Sanchez-Muniz FJ, Cuesta C, Perea S, Ureta A. Serum apolipoproteins A-I and B in male and female full-term newborns of the Toledo study (Spain). Acta Paediatr 1996;85:750-752.
56. Contois J, McNamara JR, Lammi-Keefe C, Wilson PW, Massov T, Schaefer EJ. Reference intervals for plasma apolipoprotein A-I determined with a standardized commercial immunoturbidimetric assay: results from the Framingham Offspring Study. Clin Chem 1996;42:507-514.
57. Stranberg TE, Salomaa V, Vanhanen H, Miettinen TA. Associations of fasting blood glucose with cholesterol absorption and synthesis in nondiabetic middle-aged men. Diabetes 1996;45:755-761.
58. Bachorik PS, Lovejoy KL, Carroll MD, Johnson CL, Albers JJ, Marcovina SM. Measurement of apolipoproteins A-I and B during the National Health and Nutrition Examination Survey (NHANES) III. Clin Chem 1994;40:1915-1920.
59. Graziani MS, Zanolla L, Righetti G, Marchetti C, Mocarelli P, Marcovina SM. Plasma apolipoproteins A-I and B in survivors of myocardial infarction and in a control group. Clin Chem 1998;44:134-140.
60. Jungner I, Marcovina SM, Walldius G, Holme I, Kolar W, Steiner E. Apolipoprotein B and A-I values in 147576 Swedish males and females, standardized according to the World Health Organization-International Federation of Clinical Chemistry First International Reference Materials. Clin Chem 1998;44(Pt 1):1641-1649.
61. O'Connor PM, Zysow BR, Schoenhaus SA, et al. Prebeta-1 HDL in plasma of normolipidemic individuals: influences of plasma lipoproteins, age, and gender. J Lipid Res 1998;39:670-678.
62. Puelles A, Jimenez M, Mateo G, Rodriguez MM, Eugui J. Conversion of apolipoproteins A-I and B reference limits obtained by a turbidimetric procedure to other methods. Ann Clin Biochem 1998;35(Pt 2):311-316.
63. Chang CJ, Kao JT, Wu TJ, Lu FH, Tai TY. Serum lipids and lipoprotein(a) concentrations in Chinese NIDDM patients. Relation to metabolic control. Diabetes Care 1995;18:1191-1194.
64. Bianchi C, Brambilia P, Cella D, et al. Influence of breast- and formula-feeding on plasma cholesterol precursor sterols throughout the first year of life. J Pediatr 1997;131:928-931.
65. Candlish JK, Saha N, Mak JW. Plasma lipids and apolipoproteins in a population of Orang Asli ("aborigines") from West Malaysia. Atherosclerosis 1997;129:49-51.
66. Corbo RM, Vilardo T, Mantuano E, Ruggeri M, Gemma AT, Scacchi R. Apolipoproteins B and E, and angiotensin I-converting enzyme (ACE) genetic polymorphisms in Italian women with coronary artery disease (CAD) and their relationships with plasma lipid and apolipoprotein levels. Clin Genet 1997;52:77-82.
67. Cremer P, Nagel D, Mann H, et al. Ten-year follow-up results from the Goettingen Risk, Incidence and Prevalence Study (GRIPS). I. Risk factors for myocardial infarction in a cohort of 5790 men. Atherosclerosis 1997;129:221-230.
68. Lamarche B, Tchernof A, Moorjani S, et al. Small, dense low-density lipoprotein particles as a predictor of the risk of ischemic heart disease in men. Prospective results from the Quebec Cardiovascular Study. Circulation 1997;95:69-75.
69. Yang WS, Min WK, Park JS, Kim SB. Effect of increasing serum albumin on serum lipoprotein(a) concentration in patients receiving CAPD. Am J Kidney Dis 1997;30:507-513.
70. Ascaso JF, Merchante A, Lorente RI, Real JT, Martinez-Vails J, Carmena R. A study of insulin resistance using the minimal model in nondiabetic familial combined hyperlipidemic patients. Metabolism 1998;47:508-513.
71. Couillard C, Lamarche B, Mauriege P, et al. Leptinemia is not a risk factor for ischemic heart disease in men. Prospective results from the Quebec Cardiovascular Study. Diabetes Care 1998;21:782-786.
72. Lamarche B, Tchernof A, Mauriege P, et al. Fasting insulin and apolipoprotein B levels and low-density lipoprotein particle size as risk factors for ischemie heart disease. JAMA 1998;279:1955-1961.
73. Woolf-May K, Kearney EM, Jones DW, Davison RC, Coleman D, Bird SR. The effect of two different 18-week walking programmes on aerobic fitness, selected blood lipids and factor XIIa. J Sports Sci 1998;16:701-710.
74. Contois JH, McNamara JR, Lammi-Keefe CJ, Wilson PW, Massov T, Schaefer EJ. Reference intervals for plasma apolipoprotein B determined with a standardized commercial immunoturbidimetric assay: results from the Framingham Offspring Study. Clin Chem 1996;42:515-523.
75. Matsuura T. An epidemiological study on the familial aggregation and the sequential changes of serum lipids and apolipoproteins in school children in a rural area of Awaji Island. Nippon Eiseigaku Zasshi 1990;44:1083-1096.
76. Weeke B, Krasilnikoff PA. The concentration of 21 serum proteins in normal children and adults. Acta Med Scand 1972;192:149-155.
77. Woo J, Ho SC, Wong SL, et al. Lipids, lipoproteins and other coronary risk factors in Chinese male survivors of myocardial infarction. Int J Cardiol 1993;39:195-202.
78. Luc G, Bard JM, Lussier-Cacan S, et al. High-density lipoprotein particles in octogenarians. Metabolism 1991;40:1238-1243.
79. Kwiterovich PO Jr, Coresh J, Bachorik PS. Prevalence of hyperapobetalipoproteinemia and other lipoprotein phenotypes in men (aged < or = 50 years) and women (< or = 60 years) with coronary artery disease. Am J Cardiol 1993;71:631-639.
80. Zucman D, Feneant-Thibault M, Manceur N, et al. Effects of renal transplantation on apoproteins: decrease in the B/A1 ratio atherogenicity index. Transplant Proc 1993;25(Pt 2):1377-1379.
81. Srinivasan SR, Berenson GS. Serum apolipoproteins A-I and B as markers of coronary artery disease risk in early life: the Bogalusa Heart Study. Clin Chem 1995;41:159-164.
82. Connelly PW, Poapst M, Davignon J, et al. Reference values of plasma apolipoproteins A-I and B, and association with nonlipid risk factors in the populations of two Canadian provinces: Quebec and Saskatchewan. Canadian Heart Health Surveys Research Group. Can J Cardiol 1999;15:409-418.
83. Valles V, Aguilar-Salinas CA, Gomez-Perez FJ, et al. Apolipoprotein B and A-I distribution in Mexican urban adults: results of a nationwide survey. Metabolism 2002;51:560-568.
84. Donahue RP, Jacobs DR Jr, Sidney S, Wagenknecht LE, Albers JJ, Hulley SB. Distribution of lipoproteins and apolipoproteins in young adults The CARDIA Study. Arteriosclerosis 1989;9:656-664.
85. Bao W, Srinivasan SR, Berenson GS. Tracking of serum apolipoproteins A-I and B in children and young adults: the Bogalusa Heart Study. J Clin Epidemiol 1993;46:609-616.
86. Srinivasan SR, Bao W, Berenson GS. The amount of cholesterol relative to apolipoprotein B in low-density lipoproteins relates primarily to high-density lipoprotein cholesterol in children: the Bogalusa Heart Study. Metabolism 1994;43:1042-1046.
87. Rahmani M, Raiszadeh F, Allahverdian S, Kiaii S, Navab M, Azizi F. Coronary artery disease is associated with the ratio of apolipoprotein A-I/B and serum concentration of apolipoprotein B, but not with paraoxonase enzyme activity in Iranian subjects. Atherosclerosis 2002;162:381-389.
88. Ribalta J, La Ville AE, Vallve JC, Humphries S, Turner PR, Masana L. A variation in the apolipoprotein C-III gene is associated with an increased number of circulating VLDL and IDL particles in familial combined hyperlipidemia. J Lipid Res 1997;38:1061-1069.
89. Marcovina SM, Albers JJ. Apolipoprotein assays: standardization and quality control. Scand J Clin Lab Invest Suppl 1990;198:58-65.
90. Marcovina SM, Albers JJ, Dati F, Ledue TB, Ritchie RF. International Federation of Clinical Chemistry standardization project for measurements of apolipoproteins A-I and B. Clin Chem 1991;37(Pt 1):1676-1682.
91. Albers JJ, Marcovina SM. Standardization of apolipoprotein B and A-I measurements. Clin Chem 1989;35:1357-1361.
92. Marcovina SM, Albers JJ, Kennedy H, Mei JV, Henderson LO, Hannon WH. International Federation of Clinical Chemistry standardization project for measurements of apolipoproteins A-I and B. IV. Comparability of apolipoprotein B values by use of International Reference Material. Clin Chem 1994;40:586-592.
93. Dati F. Standardization of commercial assays for serum ApoA-I and Apo-B: a consensus procedure for the calibration of reference materials. Scand J Clin Lab Invest Suppl 1990;198:73-79.
94. International Federation of Clinical Chemistry and Laboratory Medicine. Reference Materials. Apolipoprotein B. http://ifcc.org/products/reference/sp3. htm
95. International Federation of Clinical Chemistry and Laboratory Medicine. Reference Materials. Apolipoprotein AI. http://ifcc. org/products/reference/sp1. htm
96. Cobbaert C, Weykamp C, Baadenhuijsen H, Kuypers A, Lindemans J, Jansen R. Selection, preparation, and characterization of commutable frozen human serum pools as potential secondary reference materials for lipid and apolipoprotein measurements: study within the framework of the Dutch project "Calibration 2000". Clin Chem 2002;48:1526-1538.
97. Baadenhuijsen H, Steigstra H, Cobbaert C, Kuypers A, Weykamp C, Jansen R. Commutability assessment of potential reference materials using a multicenter split-patient-sample between-field-methods (twin-study) design: study within the framework of the Dutch project "Calibration 2000". Clin Chem 2002;48:1520-1525.
98. Ritchie RF, Palomaki GE, Neveux LM, Ledue TB, Craig WY, Marcovina S, Navolotskaia O. Reference distributions for apolipoproteins AI and B and the apolipoprotein B/AI ratios: a practical and clinically relevant approach in a large cohort. J Clin Lab Anal 2006;20:209-217.
99. Ritchie RF, Palomaki GE, Neveux LM, Navolotskaia O, Ledue TB, Craig WY. Reference distributions for immunoglobulins A, G, and M: a practical, simple, and clinically relevant approach in a large cohort. J Clin Lab Anal 1998;12:363-370.
100. Wilcken DE, Wang XL, Dudman NP. The Apo A, B, a of coronary risk: back to kindergarten. Aust N Z J Med 1992;22(Suppl):570-575.
101. Petersen PH, Whicher JT, Johnson AM, Itoh Y, Carlstrom AB. Strategy for determining racial and environmental similarities and differences for plasma proteins. Clin Chem Lab Med 2001;39:1146-1153.
102. National Committee for Clinical Laboratory Standards. How to define and determine reference intervals in the clinical laboratory: approved guideline. Villanova, PA: NCCLS; 1995. 1-59. NCCLS Document C28-A (ISBN 1-56238-269-1).