What question did this study set out to answer?

To characterize the analytical performance of a novel high-sensitivity cardiac troponin I assay and determine whether it improves early detection of acute myocardial injury.

January 23, 2009Clinical ChemistryOpen Access

Analytic and Clinical Utility of a Next-Generation, Highly Sensitive Cardiac Troponin I Assay for Early Detection of Myocardial Injury

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Why the study?

Does the Beckman Coulter hs-cTnI assay improve early detection of evolving myocardial injury compared to the AccuTnI assay in patients with symptoms suggestive of cardiac ischemia?

Population

125 healthy individuals and 290 subjects with symptoms suggestive of cardiac ischemia.

Comparison

Beckman Coulter high-sensitivity cardiac… vs AccuTnI assay

Design

Cohort

Follow-up

median 1 hour between specimens

Authors

PKPeter A. KavsakGeneral Cardiology AMAndrew R. MacRaeUniversidade Federal do Rio de Janeiro MYMarie-Jeanne YernaBeckman Coulter Foundation

Discussion

Member takes

Implication

May support earlier myocardial injury detection with hs-cTnI in suspected ischemia; hypothesis-generating, needs prospective validation before practice change.

Key Points

To characterize the analytical performance of a novel high-sensitivity cardiac troponin I assay and determine whether it improves early detection of acute myocardial injury.
Determined the limit of detection, precision profiles, and preliminary 99th percentile reference values across lithium heparin, serum, and EDTA plasma specimens in 125 healthy individuals (age <55 years, 54% male).
Compared early concentration change criteria between the Beckman Coulter hs-cTnI assay and the standard AccuTnI assay using the first two serial blood samples (median interval 1 h; 25th-75th percentile, 1-3 h) in patients presenting with symptoms of cardiac ischemia (n = 290).
The hs-cTnI assay achieved a limit of detection of 2.06 ng/L, with 20% and 10% CVs at 2.95 ng/L and 8.66 ng/L, and preliminary 99th percentile limits of 9.20 ng/L (heparin), 8.00 ng/L (serum), and 8.60 ng/L (EDTA plasma).
Among 108 patients with confirmed myocardial injury, the hs-cTnI assay identified 81% (95% CI 73%-88%) of cases using change criteria across the first two specimens, compared to 62% (95% CI 53%-71%) identified by the AccuTnI assay (P < 0.001).

Structured PICO

Does the Beckman Coulter hs-cTnI assay improve early detection of evolving myocardial injury compared to the AccuTnI assay in patients with symptoms suggestive of cardiac ischemia?

Population

125 healthy individuals (age <55 years, 54% male) and 290 subjects with symptoms suggestive of cardiac ischemia.

Intervention

Beckman Coulter high-sensitivity cardiac troponin I (hs-cTnI) assay

Comparator

AccuTnI assay

Outcome

Proportion of patients with myocardial injury identified by change criteria in the first 2 specimens (median time between specimens, 1 h)surrogate

The Beckman Coulter hs-cTnI assay detects evolving myocardial injury significantly earlier than the standard AccuTnI assay in patients with suspected cardiac ischemia.

Limitations

more extensive validation studies are required

Cite This Study

Kavsak et al. (2009) studied this question.

synapsesocial.com/papers/69fab3cb79c9fe70ce3f5660 https://doi.org/10.1373/clinchem.2008.116020

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Implication

May support earlier myocardial injury detection with hs-cTnI in suspected ischemia; hypothesis-generating, needs prospective validation before practice change.

Analytic and Clinical Utility of a Next-Generation, Highly Sensitive Cardiac Troponin I Assay for Early Detection of Myocardial Injury

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Analytic and Clinical Utility of a Next-Generation, Highly Sensitive Cardiac Troponin I Assay for Early Detection of Myocardial Injury

Discussion

Member takes

Implication

Key Points

Structured PICO

Limitations

Cite This Study

Also Consider

Also Consider