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

Roberts, William L; Moulton, Linda; Law, Terence C; Farrow, Genesis; Cooper-Anderson, Margaret; Savory, John; Rifai, Nader

doi:10.1093/clinchem/47.3.418

Cited by 652Clinical Laboratory Practices and Quality ControlLipoproteins and Cardiovascular HealthBiomarkers in Disease Mechanisms

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

Roberts, William L, Moulton, Linda, Law, Terence C, Farrow, Genesis, Cooper-Anderson, Margaret, Savory, John, Rifai, Nader·2001·Clinical Chemistry

DOI 10.1093/clinchem/47.3.418

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Abstract

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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Classical automated methods for CRP measurement typically have limited sensitivity in the low range of CRP concentrations in peripheral blood.
“Classical automated methods for CRP measurement typically have limited sensitivity in the low range of CRP concentrations in peripheral blood [17].”
From A high sensitivity assay is more accurate than a classical assay for the measurement of plasma CRP levels in endometriosis (2011) · cites this paper as [17]
Several hsCRP assays have been developed with improved sensitivity and precision at low concentrations of CRP.
“Several hsCRP assays have been developed with improved sensitivity and precision at low concentrations of CRP with the aim to detect subclinical inflammation [17].”
From A high sensitivity assay is more accurate than a classical assay for the measurement of plasma CRP levels in endometriosis (2011) · cites this paper as [17]

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BackgroundMethod
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Authors: Roberts, W. L., Moulton, L., Law, T. C., Farrow, G., Cooper-Anderson, M., Savory, J., & Rifai, N.
Affiliations: University of Utah (US)
ARUP Institute for Clinical and Experimental Pathology (US)
Boston Children's Hospital (US)
Departments of Pathology and
University of Virginia (US)
Corresponding author: Roberts, William L
ORCID: Roberts, William L
Rifai, Nader
Venue: Clinical Chemistry
Publisher: Oxford University Press (OUP)
Published: 2001-03-01
Volume: 47
Issue: 3
Pages: 418-425
ISSN: 0009-9147 (ISSN-L)
1530-8561
DOI: 10.1093/clinchem/47.3.418
OpenAlex: W4243536911
Cited by: 652
References: 31
Citations by year: 2026: 5 · 2025: 4 · 2024: 11 · 2023: 6 · 2022: 16 · 2021: 18 · 2020: 17 · 2019: 8 · 2018: 18 · 2017: 19 · 2016: 15 · 2015: 19 · 2014: 32 · 2013: 26 · 2012: 38
FWCI: 24.92
Type: journal article
Language: en
Open access: closed
Licence: academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
Locations: Clinical Chemistry (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
Life Sciences › Immunology and Microbiology › Immunology › Biomarkers in Disease Mechanisms
Keywords: high-sensitivity C-reactive protein, method comparison, detection limit, assay precision, prozone phenomenon, assay linearity, healthy population reference values, coronary risk prediction, assay standardization
MeSH terms: Adolescent, Adult, Aged, Autoanalysis, Blood Donors, C-Reactive Protein, Female, Humans, Immunoassay, Luminescent Measurements, Male, Middle Aged, Nephelometry and Turbidimetry, Reagent Kits, Diagnostic, Regression Analysis

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

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