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March 2, 1990, Vol 263, No. 9 >
ARTICLE | March 2, 1990

How Reliably Can Compact Chemistry Analyzers Measure Lipids? FREE

Harvey W. Kaufman, MD; Judith R. McNamara, MT; Keaven M. Anderson, PhD; Peter W. F. Wilson, MD; Ernst J. Schaefer, MD
[+] Author Affiliations

Reprint requests to the Department of Laboratory Medicine, The University Hospital, 88 E Newton St, Boston, MA 02118 (Dr Kaufman).


JAMA. 1990;263(9):1245-1249. doi:10.1001/jama.1990.03440090079031
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References

Five compact chemistry analyzers were evaluated for the measurement of lipids. Fresh plasma or serum specimens from a standardized research laboratory were assayed for total cholesterol on all five analyzers. Triglycerides and highdensity lipoprotein cholesterol were assayed on the three analyzers that could measure both of these analytes. Study results were interpreted by assessing accuracy and precision and by defining the percentage of patient specimens classified in the same categories as the reference laboratory, according to National Cholesterol Education Program guidelines. Two analyzers met standards for accuracy of cholesterol measurement. Three analyzers met performance standards for precision of cholesterol measurement. Agreement with National Cholesterol Education Program classification of specimens compared with the reference laboratory for total cholesterol ranged from 73% to 96% and was less for indirect low-density lipoprotein cholesterol. We conclude that under controlled conditions, compact chemistry analyzers vary in the reliability of lipid determination and classification of patients.

(JAMA. 1990;263:1245-1249)

REFERENCES

1 +
Kannel WB, Dawber TR, Kagan A, Revotskie N, Stokes J III.  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.
2 +
Kannel WB, Neaton JD, Wentworth D, et al.  Overall and coronary heart disease mortality rates in relation to major risk factors in 325,328 men screened for the MRFIT . Am Heart J. 1986;; 112:825-836.
3 +
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.
4 +
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.
5 +
Manninen V, Elo MO, Frick MH, et al.  Lipid alterations and decline in the incidence of coronary heart disease in the Helsinki Heart Study . JAMA. 1988;;260:641-651.
6 +
Cleeman JI.  The National Cholesterol Education Program . Clin Lab Med. 1989;;9:7-15.
7 +
 Lowering blood cholesterol to prevent heart disease . JAMA. 1985;;253:2080-2086. Consensus Conference.
8 +
 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.
9 +
 Current status of blood cholesterol measurement in clinical laboratories in the United States: a report from the Laboratory Standardization Panel of the National Cholesterol Education Program . Clin Chem. 1988;;34:193-201.
10 +
Banks P.  Study hits quality of physician office laboratories . Chem News. 1984;;10:1-2.
11 +
Wilson PWF, Christiansen JC, Anderson KM, Kannel WB.  Impact of national guidelines for cholesterol risk factor screening: the Framingham Offspring Study . JAMA. 1989;;262:41-44.
12 +
Hertz HS, Daniel A, co-chairholders. Recommendations for Improving HIV, Cholesterol, Drugs of Abuse, and Cytopathology (Pap) Testing . Villanova, Pa: National Committee for Clinical Laboratory Standards; 1989;;9:145-147.
13 +
Cooper GR, Myers GL, Smith SJ, Sampson EJ.  Standardization of lipid, lipoprotein, and apolipoprotein measurements . Clin Chem. 1988;;34( (suppl) ): B95-B105.
14 +
McNamara JR, Schaefer EJ.  Automated enzymatic lipid analyses for plasma and lipoprotein fractions . Clin Chim Acta. 1987;;166:1-8.
15 +
Warnick GR, Benderson J, Albers JJ.  Dextran sulfate-Mg + precipitation procedure for quantitation of high-density-lipoprotein cholesterol . Clin Chem. 1982;;28:1379-1388.
16 +
Friedewald WT, Levy RI, Frederickson DS.  Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge . Clin Chem. 1972;; 18:499-502.
17 +
Blank DW, Hoeg JM, Kroll MH, Ruddel ME.  The method of determination must be considered in interpreting blood cholesterol levels . JAMA. 1986;;256:2867-2870.
18 +
Koch TR, Mehta U, Lee H, et al.  Bias and precision of cholesterol analysis by physicians' office analyzers . Clin Chem. 1987;;33:2262-2267.
19 +
Rohac M, Thalhammer J, Gabl F, Bayer PM.  Impact of intensified training of operators on the determination of cholesterol on Reflotron in the doctor's office . J Clin Chem Clin Biochem. 1988;;26:39-41.
20 +
Warnick GR.  Measurement of cholesterol, triglycerides, and HDL using compact analysis systems . Clin Lab Med. 1989;;9:73-88.
21 +
Gubata P, Lefebvre RC.  Comparison testing of lot to lot variance in the Reflotron dry reagent strip method of cholesterol measurement . Clin Chem . 1989;;35:1098.
22 +
Von Schenck H, Treichl L, Tilling B, Olsson AG.  Laboratory and field evaluation of three desktop instruments for assay of cholesterol and triglyceride . Clin Chem . 1987;;33:1230-1232.
23 +
Rohac M, Rohac FG.  Evaluation of two dry reagent systems: determination of glucose, cholesterol, and triglycerols with the Reflotron and Kodak Ektachem DT-60 analyzer . J Clin Chem Clin Biochem . 1986;;24:790-791.
24 +
Kruyswijk Z, Katan MB:  Juisheid en reproduceerbaaheid van een striptest voor de snelle bepaling van plasma cholesterol in vingerprikbloed . J Dutch Soc Clin Chem . 1987;;12:178.
25 +
Burke JJ II, Fischer PM.  A clinician's guide to the office measurement of cholesterol . JAMA . 1988;;259:3444-3448.
26 +
Rastam L, Admire JB, Frantz ID Jr, et al.  Measurement of blood cholesterol with the Reflotron analyzer evaluated . Clin Chem . 1988;;34:426.
27 +
Katan MB, Kruyswijk Z.  Fingerstick cholesterol testing with the 'Reflotron.' Clin Chem . 1988;;34:1007.
28 +
Laboratory Methods Committee of the Lipid Research Clinics Program of the National Heart, Lung, and Blood Institute.  Cholesterol and triglyceride concentrations in serum/plasma pairs . Clin Chem . 1977;;23:60-63.
29 +
El-Deriny S, Ng RH, Statland BE.  Evaluation of the Kodak Ektachem DT-60 analyzer . Clin Chem . 1986;;32:1415.
30 +
Toffalettii J.  Small chemistry analyzers for physician's office testing: a survey . Lab Management. 1986;;9:37-41.
31 +
Hicks JM, Iosefsohn M.  Hemoglobin, electrolytes, and other major clinical analyses as measured with a physician's office analyzer, the Kodak DT-60 . Clin Chem . 1986;;32:2201-2203.
32 +
Belsey R, Vandenbark M, Goitein RK, Baer DM.  Evaluation of a laboratory system intended for use in physicians' offices, part II: reliability of results produced by health care workers without formal or professional laboratory training . JAMA . 1987;;258:357-361.
33 +
Stavljenic A, Vrkic N, Herak C, Kummar K, Topic E.  Analytical performance of the Vision system evaluated . Clin Chem . 1987;;33:1672-1673.
34 +
Fischer PM, Addison LA, Koneman EW, Crowley J.  Education and the physician's office laboratory . JAMA . 1986;;255:1464-1467.

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1 +
Kannel WB, Dawber TR, Kagan A, Revotskie N, Stokes J III.  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.
2 +
Kannel WB, Neaton JD, Wentworth D, et al.  Overall and coronary heart disease mortality rates in relation to major risk factors in 325,328 men screened for the MRFIT . Am Heart J. 1986;; 112:825-836.
3 +
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.
4 +
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.
5 +
Manninen V, Elo MO, Frick MH, et al.  Lipid alterations and decline in the incidence of coronary heart disease in the Helsinki Heart Study . JAMA. 1988;;260:641-651.
6 +
Cleeman JI.  The National Cholesterol Education Program . Clin Lab Med. 1989;;9:7-15.
7 +
 Lowering blood cholesterol to prevent heart disease . JAMA. 1985;;253:2080-2086. Consensus Conference.
8 +
 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.
9 +
 Current status of blood cholesterol measurement in clinical laboratories in the United States: a report from the Laboratory Standardization Panel of the National Cholesterol Education Program . Clin Chem. 1988;;34:193-201.
10 +
Banks P.  Study hits quality of physician office laboratories . Chem News. 1984;;10:1-2.
11 +
Wilson PWF, Christiansen JC, Anderson KM, Kannel WB.  Impact of national guidelines for cholesterol risk factor screening: the Framingham Offspring Study . JAMA. 1989;;262:41-44.
12 +
Hertz HS, Daniel A, co-chairholders. Recommendations for Improving HIV, Cholesterol, Drugs of Abuse, and Cytopathology (Pap) Testing . Villanova, Pa: National Committee for Clinical Laboratory Standards; 1989;;9:145-147.
13 +
Cooper GR, Myers GL, Smith SJ, Sampson EJ.  Standardization of lipid, lipoprotein, and apolipoprotein measurements . Clin Chem. 1988;;34( (suppl) ): B95-B105.
14 +
McNamara JR, Schaefer EJ.  Automated enzymatic lipid analyses for plasma and lipoprotein fractions . Clin Chim Acta. 1987;;166:1-8.
15 +
Warnick GR, Benderson J, Albers JJ.  Dextran sulfate-Mg + precipitation procedure for quantitation of high-density-lipoprotein cholesterol . Clin Chem. 1982;;28:1379-1388.
16 +
Friedewald WT, Levy RI, Frederickson DS.  Estimation of the concentration of low-density lipoprotein cholesterol in plasma, without use of the preparative ultracentrifuge . Clin Chem. 1972;; 18:499-502.
17 +
Blank DW, Hoeg JM, Kroll MH, Ruddel ME.  The method of determination must be considered in interpreting blood cholesterol levels . JAMA. 1986;;256:2867-2870.
18 +
Koch TR, Mehta U, Lee H, et al.  Bias and precision of cholesterol analysis by physicians' office analyzers . Clin Chem. 1987;;33:2262-2267.
19 +
Rohac M, Thalhammer J, Gabl F, Bayer PM.  Impact of intensified training of operators on the determination of cholesterol on Reflotron in the doctor's office . J Clin Chem Clin Biochem. 1988;;26:39-41.
20 +
Warnick GR.  Measurement of cholesterol, triglycerides, and HDL using compact analysis systems . Clin Lab Med. 1989;;9:73-88.
21 +
Gubata P, Lefebvre RC.  Comparison testing of lot to lot variance in the Reflotron dry reagent strip method of cholesterol measurement . Clin Chem . 1989;;35:1098.
22 +
Von Schenck H, Treichl L, Tilling B, Olsson AG.  Laboratory and field evaluation of three desktop instruments for assay of cholesterol and triglyceride . Clin Chem . 1987;;33:1230-1232.
23 +
Rohac M, Rohac FG.  Evaluation of two dry reagent systems: determination of glucose, cholesterol, and triglycerols with the Reflotron and Kodak Ektachem DT-60 analyzer . J Clin Chem Clin Biochem . 1986;;24:790-791.
24 +
Kruyswijk Z, Katan MB:  Juisheid en reproduceerbaaheid van een striptest voor de snelle bepaling van plasma cholesterol in vingerprikbloed . J Dutch Soc Clin Chem . 1987;;12:178.
25 +
Burke JJ II, Fischer PM.  A clinician's guide to the office measurement of cholesterol . JAMA . 1988;;259:3444-3448.
26 +
Rastam L, Admire JB, Frantz ID Jr, et al.  Measurement of blood cholesterol with the Reflotron analyzer evaluated . Clin Chem . 1988;;34:426.
27 +
Katan MB, Kruyswijk Z.  Fingerstick cholesterol testing with the 'Reflotron.' Clin Chem . 1988;;34:1007.
28 +
Laboratory Methods Committee of the Lipid Research Clinics Program of the National Heart, Lung, and Blood Institute.  Cholesterol and triglyceride concentrations in serum/plasma pairs . Clin Chem . 1977;;23:60-63.
29 +
El-Deriny S, Ng RH, Statland BE.  Evaluation of the Kodak Ektachem DT-60 analyzer . Clin Chem . 1986;;32:1415.
30 +
Toffalettii J.  Small chemistry analyzers for physician's office testing: a survey . Lab Management. 1986;;9:37-41.
31 +
Hicks JM, Iosefsohn M.  Hemoglobin, electrolytes, and other major clinical analyses as measured with a physician's office analyzer, the Kodak DT-60 . Clin Chem . 1986;;32:2201-2203.
32 +
Belsey R, Vandenbark M, Goitein RK, Baer DM.  Evaluation of a laboratory system intended for use in physicians' offices, part II: reliability of results produced by health care workers without formal or professional laboratory training . JAMA . 1987;;258:357-361.
33 +
Stavljenic A, Vrkic N, Herak C, Kummar K, Topic E.  Analytical performance of the Vision system evaluated . Clin Chem . 1987;;33:1672-1673.
34 +
Fischer PM, Addison LA, Koneman EW, Crowley J.  Education and the physician's office laboratory . JAMA . 1986;;255:1464-1467.

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