Improved Automated Immunoassay for C-Reactive Protein
Author Information
Author(s): Tie Q. Wei, Steve Kramer, Victor P. Chu, Dave Hudson, Daniel Kilgore, Sue Salyer, Grace Parker, Amy Eyberger, Rene Arentzen, Heikki Koiv
Primary Institution: Dade Behring
Hypothesis
The goal was to develop a highly sensitive CRP assay with an extended range on the Dimension1 clinical chemistry system.
Conclusion
The improved CRP method provides a sensitive, accurate, and rapid approach to quantify CRP in serum and plasma.
Supporting Evidence
- The improved CRP method was linear to 265.1 mg/l with a detection limit between 0.2 and 0.5 mg/l.
- The method detects antigen excess from the upper assay limit to 2000 mg/l.
- Calibration was stable for 60 days.
- The within-run reproducibility was less than 5.1% and total reproducibility ranged from 1.1 to 6.7%.
- Minimal interference was observed from sera of patients with elevated IgM, IgG, and IgA.
Takeaway
This study created a better test for measuring a protein that shows inflammation in the body, making it easier for doctors to get accurate results.
Methodology
The study involved optimizing a particle-enhanced turbidimetric immunoassay and comparing it with existing methods using disease state specimens.
Potential Biases
Potential bias from the use of multiple instruments and reagent lots.
Limitations
The study did not test all reagent lots manufactured for the antigen excess detection.
Participant Demographics
Specimens were from several hospitals, including patients with various conditions.
Statistical Information
P-Value
p<0.05
Confidence Interval
95% confidence interval: 0.975 to 0.993
Statistical Significance
p<0.05
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