ARCHITECT STAT High Sensitive Troponin I Familiarization Study (FAM) in the Department of Laboratory Medicine, Collegium Medicum, Nicolaus Copernicus University in Bydgoszcz, Poland

Abstract

Background. International guidelines recommend the use of cardiac troponin assays for early detection of acute myocardial infarction. New high-sensitivity assays along with improved precision and sensitivity, are now widely available, accelerating patient's diagnosis, treatment and invasive therapy. In this study we evaluated analytical performance of the Abbott ARCHITECT STAT high-sensitive troponin-I immunoassay and its 99 th percentile upper reference limit.Methods. We performed the analytical evaluation of the hs-cTnI assay using Abbott ARCHITECT i2000 SR immunoanalyzers. Features of the assay including imprecision, detection limits, linearity of dilution, interferences and method comparisons were assessed, as well as the 99 th percentile upper reference limits in a cohort of 427 presumably healthy individuals were established.Results. Total imprecision ranged from 3.1% to 4.7% and was lowest for the medium controls. The observed limit of blank, limit of detection and limit of quantitation assumed values of 0.1, 1.5 and 4.8 ng/L, respectively. Common interferences, sample dilution and carry over did not affect the hs-cTnI results. Hs-cTnI was detectable in 98% of presumably healthy individuals. The 99 th percentile values were age and sex dependent in the presumably healthy, but not in the healthy individuals. Conclusion.The new high-sensitivity troponin-I assay has improved analytical features and may be a valuable diagnostic tool.

The 99th percentile of reference population for cTnI and cTnT assay: methodology, pathophysiology and clinical implications

“…A more satisfactory definition of differences in cTnI circulating levels according to gender and age is now available thanks to the highly sensitive method using the ARCHITECT platform, able to measure biomarker values above the LoD value in the majority of healthy subjects from the day of birth to senescence [14,15,33,34,[49][50][51]. No studies found significant gender-related differences in cTnI values of pediatric age subjects (Table 2 and Figure 2) [15,33,34,50].…”