Cited by 60Clinical Laboratory Practices and Quality ControlBiomarkers in Disease MechanismsLipoproteins and Cardiovascular Health

High Sensitivity Immunoassays for C-Reactive Protein: Promises and Pitfalls

Ledue, Thomas B., Rifai, Nader·2001·Clinical Chemistry and Laboratory Medicine

Abstract

C-reactive protein (CRP) has historically been measured in the clinical laboratory for the detection and monitoring of occult infection and inflammation, using immunoturbidimetric or immunonephelometric techniques. The recent commercial availability of automated high-sensitivity assays has enabled investigators to measure CRP at levels previously unattainable on a routine basis and to explore its clinical utility in apparently healthy individuals. CRP concentrations increased above the individuals' baselines but still within the normal reference intervals have been observed in association with increasing age, obesity, and smoking and in individuals with chronic infections such as Chlamydia pneumoniae and Helicobacter pylori. More importantly, however, data from prospective studies have shown CRP to be a strong and independent predictor of future coronary events in subjects with and without coronary heart disease. An algorithm for risk assessment of coronary risk employing both CRP and lipid concentrations has recently been proposed. However, in order for this approach to be incorporated into clinical practice, agreement among the various CRP methods must be achieved. Of critical importance to this process is a basic understanding of issues affecting assay performance. Factors such as assay precision, sensitivity, matrix effects, calibration, and standardization need to be addressed adequately by the in vitro diagnostic industry and the clinical laboratory.

Integrity signals

Registry

Crossref · 10.1515/cclm.2001.185

Cites

29 of 29 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Authors
Ledue, T. B., & Rifai, N.
Affiliations
Foundation for Blood Research (US)
Venue
Clinical Chemistry and Laboratory Medicine
Published
2001-01-26
Volume
39
Issue
11
Pages
1171-6
ISSN
1434-6621 (ISSN-L)
OpenAlex
W2170492684
Cited by
60
References
29
Citations by year
2025: 1 · 2024: 3 · 2023: 1 · 2021: 3 · 2020: 1 · 2019: 1 · 2017: 2 · 2015: 2 · 2014: 1 · 2013: 1 · 2012: 2
FWCI
2.79
Type
journal article
Language
en
Open access
closed
Locations
  • Clinical Chemistry and Laboratory Medicine (CCLM) (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Life Sciences › Immunology and Microbiology › Immunology › Biomarkers in Disease Mechanisms
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
Keywords
C-reactive protein, immunoassay performance, assay precision, matrix effects, assay standardization, calibration, coronary heart disease risk prediction, inflammatory markers, Chlamydia pneumoniae, Helicobacter pylori, obesity, smoking, lipid-lowering therapy
MeSH terms
Algorithms, C-Reactive Protein, Humans, Immunoassay, Nephelometry and Turbidimetry, Reference Values, Sensitivity and Specificity, Reproducibility of Results

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review