Key result
The Access hsTnI method satisfied international criteria for high-sensitivity assays, with 99th percentile URL values greatly affected by age, sex, and statistical calculation methods.
Why the study?
The study was conducted to accurately evaluate analytical performances, the 99th percentile URL, and reference change values of the Access cTnI method among commercially available assays in Italy.
Observational (n=1,306)
Yes
The Access hs-cTnI assay meets international criteria for high-sensitivity troponin methods, highlighting the need for age- and sex-specific 99th percentile reference limits.
Supports age- and sex-specific URLs for Access hsTnI interpretation; leaves open optimal statistical methods for 99th percentiles.
BACKGROUND: The Italian Society of Clinical Biochemistry (SIBioC) and the Italian Section of the European Ligand Assay Society (ELAS) have recently promoted a multicenter study (Italian hs-cTnI Study) with the aim to accurately evaluate analytical performances and reference values of the most popular cTnI methods commercially available in Italy. The aim of this article is to report the results of the Italian hs-cTnI Study concerning the evaluation of the 99th percentile URL and reference change (RCV) values around the 99th URL of the Access cTnI method. MATERIALS AND METHODS: Heparinized plasma samples were collected from 1306 healthy adult volunteers by 8 Italian clinical centers. Every center collected from 50 to 150 plasma samples from healthy adult subjects. All volunteers denied the presence of chronic or acute diseases and had normal values of routine laboratory tests (including creatinine, electrolytes, glucose and blood counts). An older cohort of 457 adult subjects (mean age 63.0 years; SD 8.1 years, minimum 47 years, maximum 86 years) underwent also ECG and cardiac imaging analysis in order to exclude the presence of asymptomatic cardiac disease. RESULTS AND CONCLUSIONS: The results of the present study confirm that the Access hsTnI method using the DxI platform satisfies the two criteria required by international guidelines for high-sensitivity methods for cTn assay. Furthermore, the results of this study confirm that the calculation of the 99th percentile URL values are greatly affected not only by age and sex of the reference population, but also by the statistical approach used for calculation of cTnI distribution parameters.
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Clerico et al. (2019) conducted an observational in Healthy adults (n=1,306). Access hsTnI method was evaluated on 99th percentile URL and reference change (RCV) values. The Access hsTnI method satisfied international criteria for high-sensitivity assays, with 99th percentile URL values greatly affected by age, sex, and statistical calculation methods.
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