Key result
MAGLUMI CLIA hs-cTnI establishes a ~7.2 ng/L upper reference limit, with higher levels in men.
Why the study?
The study evaluated the analytical characteristics, performance, and 99th percentile URL value of a new CLIA high-sensitivity cardiac troponin I method.
Cross-Sectional (n=1,037)
Yes
The MAGLUMI CLIA hs-cTnI method meets international guideline criteria and establishes sex- and age-specific 99th percentile upper reference limits.
Enables sex-specific hs-cTnI thresholds with this CLIA assay; extends reference data but leaves open prospective outcome validation.
OBJECTIVES: CLIA high-sensitivity cardiac troponin I (hs-cTnI) method. METHODS: Analytical performances and the 99th percentile URL value of the chemi-luminescent-immuno-assay (CLIA) method were evaluated using validated and standardized experimental protocols. Two cohorts including healthy adult individuals were enrolled. The first one included 989 blood donor volunteers (489 women and 500 men) aged 18-70 years (mean age 43 years, interquartile range 31-54 years). The second population included 47 healthy individuals (31 women and 16 men, mean age 78 years, interquartile range 73-81 years) aged≥71 years. RESULTS: The distributions of hs-cTnI levels in both sexes are highly right-skewed, and men show significantly (p=0.0028) higher biomarker values than women. Moreover, in both sexes the hs-cTnI levels progressively increase after the 55 years. In the multivariate analysis (n=958), hs-cTnI was found to be significantly associated to NT-proBNP (p<0.0001), sex (p<0.0001) and BMI (p=0.0424). The 99th percentile URL values, calculated using the bootstrap method in the total reference heathy population (age≥18 years), were: Females (n=521): 5.93 ng/L (CI 95 % 5.29-8.48), Males (n=516): 9.79 ng/L (CI 95 % 6.37-17.41 ng/L), Total Population (n=1,037): 7.18 ng/L (CI 6.08-12.20 ng/L). CONCLUSIONS: The MAGLUMI CLIA method met all the criteria for an hs-cTnI assay recommended by international guidelines. The hs-cTnI values measured with the CLIA method are higher in men compared to women at the same age, and also progressively increase after the age>55 years.
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Fasano et al. (2025) conducted a cross-sectional in Healthy adults (n=1,037). MAGLUMI CLIA hs-cTnI was evaluated on 99th percentile upper reference limit (URL) (95% CI 6.08-12.20). The MAGLUMI CLIA hs-cTnI method demonstrated a 99th percentile upper reference limit of 7.18 ng/L in the total healthy population, with significantly higher values in men compared to women.
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