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Analytical and clinical evaluation of the Bayer ADVIA Centaur homocysteine assay
Prakash C Tewari1, Bin Zhang, Barry I Bluestein
1Bayer Healthcare LLC, Diagnostics Division, Laboratory Testing Segment, Research and Development, 511 Benedict Avenue, Tarrytown, NY 10591, USA. prakash.tewari.b@bayer.com
Insights
This study introduces a new assay for measuring homocysteine (Hcy), a marker linked to cardiovascular disease risk. The automated assay is precise and accurate, aiding in early cardiovascular risk assessment.
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
- Cardiovascular Disease Research
Background:
- Cardiovascular disease (CVD) is a leading cause of mortality in the US.
- Elevated homocysteine (Hcy) levels are associated with increased risk of cardiovascular events.
- There is a need for high-throughput, accurate assays for Hcy measurement.
Purpose of the Study:
- To evaluate the performance characteristics of the automated Bayer ADVIA Centaur chemiluminescent Hcy assay.
- To assess the assay's accuracy, precision, and linearity for Hcy quantification.
Main Methods:
- The Centaur Hcy assay utilizes a three-step process: disulfide reduction, enzymatic conversion to S-adenosyl Hcy (SAH), and competitive immunoassay for SAH.
- Assay performance was evaluated for precision, linearity, and method comparison against fluorescent polarization immunoassay and HPLC.
Main Results:
- The assay demonstrated good precision (3.5%–6.8%) and linearity up to 65 micromol/L (undiluted) and 650 micromol/L (with dilution).
- Method comparisons showed strong agreement with existing methods (slopes 0.95–1.0).
- Hcy levels in healthy populations indicated a 9.7 micromol/L 95th percentile, aligning with CVD risk thresholds.
Conclusions:
- The Bayer ADVIA Centaur Hcy assay is a sensitive and precise method for measuring homocysteine.
- This assay supports the accurate assessment of Hcy as a cardiovascular risk marker.
Background:
Cardiovascular disease (CVD) is the leading cause of death in the United States. Elevations in homocysteine (Hcy) have been associated with increased risk of acute coronary syndrome, stroke and peripheral vascular disease. Increased utilization of Hcy as a risk marker has prompted the need for high throughput methods that are simple to use and analytically accurate and precise.
Methods:
We report the performance characteristics of the automated Bayer ADVIA Centaur chemiluminescent Hcy assay. Centaur Hcy is based on a three-step procedure: (1) reduction of Hcy disulfides to free Hcy, (2) enzymatic conversion of free Hcy to S-adenosyl Hcy (SAH) and (3) quantitation of SAH in a competitive immunoassay (labeled anti-SAH antibody: magnetic particles coupled with SAH).
Results:
Total assay precision ranged from 3.5% to 6.8% at 4.9-62 micromol/Hcy; linearity undiluted from 0 to 65 micromol/l, up to 650 micromol/l with automatic dilution. Method comparisons with fluorescent polarization immunoassay and high-performance liquid chromatography (HPLC) gave linear regression equations with slopes between 0.95 and 1.0. Measurement of Hcy concentrations in apparently healthy populations yielded middle 95th percentile of 9.7 micromol/l, consistent with epidemiologic studies suggesting that 9-10 micromol/l represents the lower threshold of a population at risk of CVD.
Conclusions:
The Centaur Hcy assay is a sensitive and precise assay for the measurement of Hcy.
