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 99th percentile upper reference limit.

Methods. We performed the analytical evaluation of the hs-cTnI assay using Abbott ARCHITECT i2000SR immunoanalyzers. Features of the assay including imprecision, detection limits, linearity of dilution, interferences and method comparisons were assessed, as well as the 99th 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 99th 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.