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ARTICLE |

A Clinician's Guide to the Office Measurement of Cholesterol FREE

James J. Burke, II; Paul M. Fischer, MD
[+] Author Affiliations

Reprint requests to the Department of Family Medicine, Medical College of Georgia, 1423 Harper St, Augusta, GA 30912 (Dr Fischer).


JAMA. 1988;259(23):3444-3448. doi:10.1001/jama.1988.03720230054030
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The office laboratory has the potential to be an ideal setting for cholesterol testing if accurate test results are achieved. This study describes the performance of three office chemistry analyzers (Abbott Vision, Boehringer-Mannheim Reflotron, and Kodak Ektachem DT60 Analyzer) in the measurement of cholesterol. The accuracy of these instruments was assessed by testing aliquots of 84 plasma specimens and comparing these results with values obtained in one of the National Heart, Lung, and Blood Institute's Lipid Research Clinic laboratories. To evaluate instrument precision, results from each of the three instruments were compared with the cholesterol standards recently released by the College of American Pathologists. When operated according to the manufacturers' recommended procedures, each of the three instruments demonstrated analytic capabilities that met the current accuracy and precision goals established by the National Cholesterol Education Program. Analytic issues that are pertinent to the clinician's role as both the office laboratory director and the test interpreter are reviewed.

(JAMA 1988;259:3444-3448)

REFERENCES

Kannel WB, Dawber TR, Kagan A, et al:  Factors of risk in the development of coronary heart disease: Six year follow-up experience: The Framingham study. Ann Intern Med 1961;;55:33-50.
Kannel WB, Castelli WP, Gordon T, et al:  Serum cholesterol, lipoproteins and the risk of coronary heart disease: The Framingham study. Ann Intern Med 1971;;74:1-11.
Lipid Research Clinics Program:  The Lipid Research Clinics Coronary Primary Prevention Trial results: I. Reduction in incidence of coronary heart disease. JAMA 1984;;251:351-364.
Lipid Research Clinics Program:  The Lipid Research Clinics Coronary Primary Prevention Trial results: II. The relationship of reduction in incidence of coronary heart disease to cholesterol lowering. JAMA 1984;;251:365-374.
Taylor WC, Pass TM, Shepard DS, et al:  Cholesterol reduction and life expectancy. Ann Intern Med 1987;;106:605-614.
 Lowering blood cholesterol to prevent heart disease, CONSENSUS CONFERENCE. JAMA 1985;; 253:2080-2086.
The Expert Panel:  Report of the National Cholesterol Education Program expert panel on detection, evaluation, and treatment of high blood cholesterol in adults. Arch Intern Med 1988;;148:36-69.
Fischer PM, Addison LA:  The office laboratory director's guide. JAMA 1985;;254:2941-2945.
Wynder EL, Field F, Haley NJ:  Population screening for cholesterol determination: A pilot study. JAMA 1986;;256:2839-2842.
Greenland P, Levenkron JC, Radley MG, et al:  Feasibility of large-scale cholesterol screening: Experience with portable capillary-blood testing device. Am J Public Health 1987;;77:73-75.
Von Schenck H, Treichl L, Tilling B, et al:  Laboratory and field evaluation of three desk top instruments for assay of cholesterol and triglyceride. Clin Chem 1987;;33:1230-1232.
Koch TR, Mehta U, Lee H, et al:  Bias and precision of cholesterol analysis by physician's office analyzers. Clin Chem 1987;;33:2262-2267.
User Comparison of Quantitative Clinical Laboratory Methods Using Patient Samples: Proposed Guideline , publication EP-9-P. Villanova, Pa, National Committee for Clinical Laboratory Standards, 1986;.
Duncan I, Mather A, Cooper G: The Procedure for the Proposed Cholesterol Reference Method . Atlanta, Centers for Disease Control, 1982;.
Cohen A, Hertz H, Mandel J, et al:  Total serum cholesterol by isotope dilution/mass spectrometry: A candidate definitive method. Clin Chem 1980;;26:854-860.
Hartmann AE: Physician's Office Laboratory Guidelines: Proposed Guidelines . Villanova, Pa, National Committee for Clinical Laboratory Standards, 1987;.
Alain CC, Poon LS, Chan CS, et al:  Enzymatic determination of total serum cholesterol. Clin Chem 1974;;20:470-475.
Artiss JD, Zak B:  A sensitive reaction for dilute cholesterol determinations. Microchem J 1980;;25:535-542.
Schultz SG, Holen JT, Donohue JP, et al:  Two dimensional centrifugation for desk-top clinical chemistry. Clin Chem 1985;;31:1457-1463.
Zipp A:  Development of dry reagent chemistry for the clinical laboratory. J Automat Chem 1981;;3:71-75.
Walter B:  Dry reagent chemistries in clinical analysis, abstracted. Anal Chem 1983;;55:498A-514A.
Naito HK, Hartmann AE: The ABC's of Cholesterol Standardization . Skokie, Ill, College of American Pathologists, 1987;.
Blank DW, Hoeg JM, Kroll MH, et al:  The method of determination must be considered in interpreting blood cholesterol levels. JAMA 1986;;256:2767-2770.
Fischer PM, Addison LA, Koneman EW, et al:  Education and the physician's office laboratory. JAMA 1986;;255:1464-1467.
The National Reference System for the Clinical Laboratory , publication RS3-A. Villanova, Pa, National Committee for Clinical Laboratory Standards, 1987;.
Burke JJ, Parramore HP, Fischer PM:  Combined screening: Blood pressure and cholesterol. JAMA 1988;;259:518-519.
College of American Pathologists External Comparative Evaluation for Laboratories, Set XL-F . Skokie, Ill, College of American Pathologists, 1987;.
Belsey R, Vandenbark M, Goitein RK, et al:  Evaluation of a laboratory system intended for use in physician's offices: II. Reliability of results produced by health care workers without formal or professional laboratory training. JAMA 1987;;258:357-361.
Reference Material for Serum Cholesterol . Skokie, Ill, College of American Pathologists, 1987;.

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Kannel WB, Dawber TR, Kagan A, et al:  Factors of risk in the development of coronary heart disease: Six year follow-up experience: The Framingham study. Ann Intern Med 1961;;55:33-50.
Kannel WB, Castelli WP, Gordon T, et al:  Serum cholesterol, lipoproteins and the risk of coronary heart disease: The Framingham study. Ann Intern Med 1971;;74:1-11.
Lipid Research Clinics Program:  The Lipid Research Clinics Coronary Primary Prevention Trial results: I. Reduction in incidence of coronary heart disease. JAMA 1984;;251:351-364.
Lipid Research Clinics Program:  The Lipid Research Clinics Coronary Primary Prevention Trial results: II. The relationship of reduction in incidence of coronary heart disease to cholesterol lowering. JAMA 1984;;251:365-374.
Taylor WC, Pass TM, Shepard DS, et al:  Cholesterol reduction and life expectancy. Ann Intern Med 1987;;106:605-614.
 Lowering blood cholesterol to prevent heart disease, CONSENSUS CONFERENCE. JAMA 1985;; 253:2080-2086.
The Expert Panel:  Report of the National Cholesterol Education Program expert panel on detection, evaluation, and treatment of high blood cholesterol in adults. Arch Intern Med 1988;;148:36-69.
Fischer PM, Addison LA:  The office laboratory director's guide. JAMA 1985;;254:2941-2945.
Wynder EL, Field F, Haley NJ:  Population screening for cholesterol determination: A pilot study. JAMA 1986;;256:2839-2842.
Greenland P, Levenkron JC, Radley MG, et al:  Feasibility of large-scale cholesterol screening: Experience with portable capillary-blood testing device. Am J Public Health 1987;;77:73-75.
Von Schenck H, Treichl L, Tilling B, et al:  Laboratory and field evaluation of three desk top instruments for assay of cholesterol and triglyceride. Clin Chem 1987;;33:1230-1232.
Koch TR, Mehta U, Lee H, et al:  Bias and precision of cholesterol analysis by physician's office analyzers. Clin Chem 1987;;33:2262-2267.
User Comparison of Quantitative Clinical Laboratory Methods Using Patient Samples: Proposed Guideline , publication EP-9-P. Villanova, Pa, National Committee for Clinical Laboratory Standards, 1986;.
Duncan I, Mather A, Cooper G: The Procedure for the Proposed Cholesterol Reference Method . Atlanta, Centers for Disease Control, 1982;.
Cohen A, Hertz H, Mandel J, et al:  Total serum cholesterol by isotope dilution/mass spectrometry: A candidate definitive method. Clin Chem 1980;;26:854-860.
Hartmann AE: Physician's Office Laboratory Guidelines: Proposed Guidelines . Villanova, Pa, National Committee for Clinical Laboratory Standards, 1987;.
Alain CC, Poon LS, Chan CS, et al:  Enzymatic determination of total serum cholesterol. Clin Chem 1974;;20:470-475.
Artiss JD, Zak B:  A sensitive reaction for dilute cholesterol determinations. Microchem J 1980;;25:535-542.
Schultz SG, Holen JT, Donohue JP, et al:  Two dimensional centrifugation for desk-top clinical chemistry. Clin Chem 1985;;31:1457-1463.
Zipp A:  Development of dry reagent chemistry for the clinical laboratory. J Automat Chem 1981;;3:71-75.
Walter B:  Dry reagent chemistries in clinical analysis, abstracted. Anal Chem 1983;;55:498A-514A.
Naito HK, Hartmann AE: The ABC's of Cholesterol Standardization . Skokie, Ill, College of American Pathologists, 1987;.
Blank DW, Hoeg JM, Kroll MH, et al:  The method of determination must be considered in interpreting blood cholesterol levels. JAMA 1986;;256:2767-2770.
Fischer PM, Addison LA, Koneman EW, et al:  Education and the physician's office laboratory. JAMA 1986;;255:1464-1467.
The National Reference System for the Clinical Laboratory , publication RS3-A. Villanova, Pa, National Committee for Clinical Laboratory Standards, 1987;.
Burke JJ, Parramore HP, Fischer PM:  Combined screening: Blood pressure and cholesterol. JAMA 1988;;259:518-519.
College of American Pathologists External Comparative Evaluation for Laboratories, Set XL-F . Skokie, Ill, College of American Pathologists, 1987;.
Belsey R, Vandenbark M, Goitein RK, et al:  Evaluation of a laboratory system intended for use in physician's offices: II. Reliability of results produced by health care workers without formal or professional laboratory training. JAMA 1987;;258:357-361.
Reference Material for Serum Cholesterol . Skokie, Ill, College of American Pathologists, 1987;.
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