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Clinical Chemistry 47: 418-425, 2001;
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(Clinical Chemistry. 2001;47:418-425.)
© 2001 American Association for Clinical Chemistry, Inc.

Articles

Evaluation of Nine Automated High-Sensitivity C-Reactive Protein Methods: Implications for Clinical and Epidemiological Applications. Part 2

William L. Roberts1,a, Linda Moulton2, Terence C. Law3, Genesis Farrow3, Margaret Cooper-Anderson4, John Savory4,5 and Nader Rifai3

1 Department of Pathology, University of Utah Health Sciences Center, Salt Lake City, UT 84132.

2 ARUP Institute for Experimental and Clinical Pathology, Salt Lake City, UT 84108.

3 Departments of Laboratory Medicine and Pathology, Children’s Hospital and Harvard Medical School, Boston, MA 02115.

4 Departments of Pathology and
5 Biochemistry and Molecular Genetics, University of Virginia Health Science Center, Charlottesville, VA 22908.
a Address correspondence to this author at: c/o ARUP Laboratories, 500 Chipeta Way, Salt Lake City, UT 84108. Fax 801-584-5207; e-mail william.roberts{at}arup-lab.com.

Background: C-Reactive protein (CRP) can provide prognostic information about risk of future coronary events in apparently healthy subjects. This application requires higher sensitivity assays than have traditionally been available in the clinical laboratory.

Methods: Nine high-sensitivity CRP (hs-CRP) methods from Dade Behring, Daiichi, Denka Seiken, Diagnostic Products Corporation, Iatron, Kamiya, Olympus, Roche, and Wako were evaluated for limit of detection, linearity, precision, prozone effect, and comparability with samples from 388 apparently healthy individuals.

Results: All methods had limits of detection that were lower than the manufacturers’ claimed limit of quantification except for the Kamiya, Roche, and Wako methods. All methods were linear at 0.3–10 mg/L. The Diagnostic Products Corporation, Kamiya, Olympus, and Wako methods had imprecision (CVs) >10% at 0.15 mg/L. The Iatron, Olympus, and Wako methods demonstrated prozone effects at hs-CRP concentrations of 12, 206, and 117 mg/L, respectively. hs-CRP concentrations demarcating each quartile in a healthy population were method-dependent. Ninety-two to 95% of subjects were classified into the same quartile of hs-CRP established by the Dade Behring method by the Denka Seiken, Diagnostic Products Corporation, Iatron, and Wako methods. In contrast, 68–77% of subjects were classified into the same quartile by the Daiichi, Kamiya, Olympus, and Roche methods. No subject varied by more than one quartile by any method.

Conclusions: Four of the nine examined hs-CRP methods classified apparently healthy subjects into quartiles of hs-CRP similar to the classifications assigned by the comparison method. Additional standardization efforts are required because an individual patient’s results will be interpreted using population-based cutpoints.




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J. Middleton
Effect of Analytical Error on the Assessment of Cardiac Risk by the High-Sensitivity C-Reactive Protein and Lipid Screening Model
Clin. Chem., November 1, 2002; 48(11): 1955 - 1962.
[Abstract] [Full Text] [PDF]

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 Hum ReprodHome page
P. Garnero, C. Jamin, C.-L. Benhamou, C. Pelissier, and C. Roux
Effects of tibolone and combined 17{beta}-estradiol and norethisterone acetate on serum C-reactive protein in healthy post-menopausal women: a randomized trial
Hum. Reprod., October 1, 2002; 17(10): 2748 - 2753.
[Abstract] [Full Text] [PDF]

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 StrokeHome page
A. D. Blann, P. M. Ridker, and G. Y.H. Lip
Inflammation, Cell Adhesion Molecules, and Stroke: Tools in Pathophysiology and Epidemiology?
Stroke, September 1, 2002; 33(9): 2141 - 2143.
[Full Text] [PDF]

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 Clin. Chem.Home page
M. Ishibashi, Y. Takemura, H. Ishida, K. Watanabe, and T. Kawai
C-Reactive Protein Kinetics in Newborns: Application of a High-Sensitivity Analytic Method in Its Determination
Clin. Chem., July 1, 2002; 48(7): 1103 - 1106.
[Full Text] [PDF]

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 Clin. Chem.Home page
S. Rothkrantz-Kos, M. P.J. Schmitz, O. Bekers, P. P.C.A. Menheere, and M. P. van Dieijen-Visser
High-Sensitivity C-Reactive Protein Methods Examined
Clin. Chem., February 1, 2002; 48(2): 359 - 362.
[Full Text] [PDF]

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 Circ. Res.Home page
G. J. Blake and P. M. Ridker
Novel Clinical Markers of Vascular Wall Inflammation
Circ. Res., October 26, 2001; 89(9): 763 - 771.
[Abstract] [Full Text] [PDF]

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 Clin. Chem.Home page
R. S. Ayash
Re: Europium nanoparticles and time-resolved fluorescence for ultrasensitive detection of prostate-specific antigen.
Clin. Chem., September 1, 2001; 47(9): 1743 - 1744.
[Full Text] [PDF]

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 JAMAHome page
M. A. Albert, E. Danielson, N. Rifai, P. M Ridker, and for the PRINCE Investigators
Effect of Statin Therapy on C-Reactive Protein Levels: The Pravastatin Inflammation/CRP Evaluation (PRINCE): A Randomized Trial and Cohort Study
JAMA, July 4, 2001; 286(1): 64 - 70.
[Abstract] [Full Text] [PDF]

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 CirculationHome page
P. M. Ridker
High-Sensitivity C-Reactive Protein : Potential Adjunct for Global Risk Assessment in the Primary Prevention of Cardiovascular Disease
Circulation, April 3, 2001; 103(13): 1813 - 1818.
[Abstract] [Full Text] [PDF]


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