Multicenter Evaluation of a High-Sensitivity Troponin I Assay and Verification of an Early Rule-Out Algorithm

The objectives of this study were to independently evaluate the analytical performance of the STAT high-sensitivity troponin I (hs-cTnI) assay on a recently launched and CE-marked integrated chemistry and immunoassay system, confirm acceptable performance of the assay in line with The Third Global MI Task Force recommendations, and confirm suitability of the assay for continued use of an early rule-out algorithm for acute coronary syndrome at our Trust.

A multicenter evaluation of the analytical performance characteristics of the hs-cTnI assay on the Abbott Alinity ci series was performed in 5 clinical laboratories across Europe. Comparison studies were performed vs the existing Abbott ARCHITECT hs-cTnI assay.

Passing and Bablok regression analysis revealed a slope of 0.99 [95% confidence interval (CI), 0.98-1.00] and an intercept of -0.09 ng/L (95% CI, -0.21-0.11). Intermediate imprecision ranged from 3.7% to 5.4%, 2.6% to 4.5%, and 2.0% to 6.1% at concentrations of 19.1-21.1 ng/L, 196.6-205.5 ng/L, and 15229-16265 ng/L, respectively. There was good concordance between the 2 assays at the early rule-out cutoff.

Comparable analytical performance of the hs-cTnI assay on new Abbott Alinity ci series supports the continued use of the early rule out algorithm for patients with suspected ACS at our Trust.