Analytical characteristics and performance of a new hs-cTnI method: a multicenter-study

Area of Science:

• Clinical Chemistry
• Cardiovascular Diagnostics
• Biomarker Assay Validation

Background:

• High-sensitivity cardiac troponin I (hs-cTnI) assays are crucial for diagnosing acute myocardial infarction.
• Establishing accurate reference ranges, particularly the 99th percentile upper reference limit (URL), is essential for clinical interpretation.
• The MAGLUMI CLIA method is a novel assay requiring thorough analytical validation.

Purpose of the Study:

• To evaluate the analytical performance of the MAGLUMI CLIA hs-cTnI assay.
• To determine the 99th percentile upper reference limit (URL) in a healthy adult population.
• To assess the influence of sex and age on hs-cTnI levels.

Main Methods:

• Multicenter study involving two cohorts of healthy adults (n=1036).
• Analytical performance was assessed using validated protocols.
• The 99th percentile URL was calculated using the bootstrap method.

Main Results:

• The MAGLUMI CLIA hs-cTnI assay demonstrated acceptable analytical performance.
• hs-cTnI levels were significantly higher in men than in women (p=0.0028).
• hs-cTnI levels showed a progressive increase after age 55 in both sexes.
• The 99th percentile URL values were 5.93 ng/L for females, 9.79 ng/L for males, and 7.18 ng/L for the total population.

Conclusions:

• The MAGLUMI CLIA method meets international guidelines for hs-cTnI assays.
• The assay provides reliable measurements of hs-cTnI.
• Clinicians should consider sex and age (especially >55 years) when interpreting hs-cTnI results from this assay.