Key result
High-sensitivity cardiac troponin assays showed analytic variation, with maximum mean differences of ±4, ±8, and ±9 ng/L for normal, female, and male 99th-percentile samples, respectively.
Why the study?
What is the analytic result variation for high-sensitivity cardiac troponin assays across different instruments and clinical laboratories?
Observational
Yes
What is the analytic result variation for high-sensitivity cardiac troponin assays across different instruments and clinical laboratories?
High-sensitivity cardiac troponin assays exhibit analytic variation across instruments and sites, which may impact clinical interpretation near the 99th-percentile diagnostic thresholds.
Variability in hs-troponin results across labs may affect MI diagnostic thresholds; leaves open assay-specific standardization needs.
A multicentre prospective observational study (36 sites in 8 Canadian provinces), imbedded in the CODE-MI trial, had clinical laboratories at these sites test 3 samples (normal, female 99th-percentile, and male 99th-percentile concentrations) monthly for 1 year on 67 instruments, producing 2142 results from 6 distinct troponin assays. Mean differences varied per assay with maximum values being ± 4, ± 8, and ± 9 ng/L for the normal, female 99th-percentile, and male 99th-percentile sample, respectively.
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Kavsak et al. (2023) conducted an observational in High-Sensitivity Cardiac Troponin testing. High-sensitivity cardiac troponin assays was evaluated on Mean differences in troponin concentrations. High-sensitivity cardiac troponin assays showed analytic variation, with maximum mean differences of ±4, ±8, and ±9 ng/L for normal, female, and male 99th-percentile samples, respectively.
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