Key result
The STAT hs-cTnI assay on the Abbott Alinity ci series demonstrated comparable analytical performance to the ARCHITECT assay (regression slope 0.99; 95% CI 0.98-1.00).
Why the study?
The study evaluated the analytical performance of the STAT hs-cTnI assay on an integrated chemistry and immunoassay system and assessed its suitability for continued use of an early rule-out algorithm for ACS.
Does the hs-cTnI assay on the Abbott Alinity ci series have comparable analytical performance to the Abbott ARCHITECT assay for early rule-out of acute coronary syndrome?
Observational
Yes
Does the hs-cTnI assay on the Abbott Alinity ci series have comparable analytical performance to the Abbott ARCHITECT assay for early rule-out of acute coronary syndrome?
Effect estimate: slope 0.99 (95% CI 0.98-1.00)
The hs-cTnI assay on the new Abbott Alinity ci series demonstrates comparable analytical performance to the existing ARCHITECT assay, supporting its continued use in early rule-out algorithms for suspected acute coronary syndrome.
Supports Alinity hs-cTnI adoption in labs; leaves open clinical outcome validation in diverse settings.
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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Sharrod–Cole et al. (2019) conducted an observational in Acute coronary syndrome. STAT high-sensitivity troponin I (hs-cTnI) assay on Abbott Alinity ci series vs. Abbott ARCHITECT hs-cTnI assay was evaluated on Analytical performance (Passing and Bablok regression slope) (slope 0.99, 95% CI 0.98-1.00). The STAT hs-cTnI assay on the Abbott Alinity ci series demonstrated comparable analytical performance to the ARCHITECT assay (regression slope 0.99; 95% CI 0.98-1.00).
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