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Updated: Jun 27, 2026
Profiling of Methyltransferases and Other S-adenosyl-L-homocysteine-binding Proteins by Capture Compound Mass Spectrometry (CCMS)
Published on: December 20, 2010
Performance characteristics of six homocysteine assays
Sonia L La'ulu1, Mindy L Rawlins, Christine M Pfeiffer
1ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT 84108, USA.
Insights
This study evaluated homocysteine (Hcy) measurement methods, finding most acceptable, but IMMULITE showed lower precision and accuracy. Standardization efforts are ongoing for reliable Hcy testing.
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
- Diagnostic Assay Evaluation
Background:
- Elevated homocysteine (Hcy) concentrations are linked to various health disorders.
- Accurate measurement of Hcy is crucial for diagnosing and managing related conditions.
Purpose of the Study:
- To evaluate the performance of multiple homocysteine assay methods.
- To assess linearity, imprecision, interference, method comparison, and accuracy of different Hcy testing platforms.
Main Methods:
- Evaluated ADVIA Centaur, ARCHITECT i2000SR, AxSYM, IMMULITE 2000, Catch, and Diazyme methods.
- Assessed linearity, imprecision (CVs 1.7%-9.4%), interference (hemolysis, icterus, lipemia).
- Performed method comparison against HPLC; assessed accuracy using NIST SRM 1955.
Main Results:
- All methods demonstrated good linearity (<10% deviation).
- Correlation coefficients ranged from 0.95 to 0.99; bias varied from -29.3% to 7.2%.
- Only one method met accuracy standards across all levels; IMMULITE showed lower precision and accuracy.
Conclusions:
- Most evaluated homocysteine methods exhibit acceptable performance.
- The IMMULITE 2000 method requires improvement in precision and accuracy.
- Continued standardization efforts are necessary for reliable Hcy quantification.
Abstract:
Elevated concentrations of homocysteine (Hcy) are associated with a range of disorders. Linearity, imprecision, interference, method comparison, and accuracy were evaluated on the ADVIA Centaur (Siemens Healthcare Diagnostics, Deerfield, IL), ARCHITECT i2000SR (Abbott Diagnostics, Abbott Park, IL), AxSYM (Abbott Diagnostics), and IMMULITE 2000 (Siemens Healthcare Diagnostics) methods and analyzers and the Catch (Equal Diagnostics, Exton, PA) and Diazyme (Diazyme Laboratories, San Diego, CA) methods, both on the Modular P analyzer (Roche Diagnostics, Indianapolis, IN). All methods were linear with maximum deviations from target recoveries of less than 10%. Total coefficients of variation ranged from 1.7% to 9.4%. The effects of hemolysis, icterus, and lipemia were assessed. Method comparisons were performed using high-performance liquid chromatography as the comparison method. Correlation coefficients were 0.95 to 0.99. Bland-Altman plots demonstrated percentage bias of -29.3% (IMMULITE) to 7.2% (Centaur). Accuracy using the National Institute of Standards and Technology Standard Reference Material 1955 showed varying results with only 1 method within the certified range for all 3 levels. All methods demonstrated acceptable performance except the IMMULITE, which is less precise and accurate. Standardization of most methods seems acceptable, although continuing efforts are warranted.
