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Articles |
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,
Childrens Hospital and Harvard Medical School, Boston, MA 02115.
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 the risk of developing atherosclerotic complications in apparently healthy patients. This new clinical application requires quantification of CRP concentrations below those traditionally measured in the clinical laboratory.
Methods: The Dade Behring BN II, the Abbott IMx, the Diagnostic Products Corporation IMMULITE, and the Beckman Coulter IMMAGE are four automated analyzers with high-sensitivity CRP (hs-CRP) methods. We evaluated these assays for precision, linearity, and comparability with samples from 322 apparently healthy blood donors.
Results: The imprecision (CV) of the BN II, IMx, IMMULITE, and
IMMAGE methods was
7.6%,
12%,
9.8%, and
9.7% at 3.5
mg/L, respectively. The BN II, IMx, IMMULITE, and IMMAGE methods were
linear down to
0.30,
0.32,
0.85, and 2.26 mg/L, respectively. CRP
concentrations demarcating each quartile in a healthy population were
method dependent. The IMx method gave results comparable to the BN II
method for values in the reference interval. The IMMULITE method had a
positive intercept compared with the BN II method. The IMMAGE method
demonstrated more scatter and a positive intercept compared with the BN
II method, which may reflect the fact that it is a less sensitive
assay.
Conclusions: The four hs-CRP methods exhibited differences in results for a healthy population. Additional standardization efforts are required to ensure that hs-CRP results can be related to large-scale epidemiologic studies.
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