Abstract
Differences in patient classification of myocardial injury between high-sensitivity cardiac troponin (hs-cTn) assays have largely been attributed to assay design and analytical sensitivity aspects. Our objective was to compare Ortho Clinical Diagnostics’ (OCD) hs-cTnI assay to OCD’s contemporary/conventional assay (cTnI ES) and another hs-cTnI assay (Abbott hs-cTnI) in samples obtained from different emergency departments (EDs). Two different sample types were evaluated (lithium heparin and ethylenediaminetetraacetic acid (EDTA) plasma) in a non-selected ED population (study 1, n = 469 samples) and in patients for which ED physicians ordered cardiac troponin testing (study 2, n = 1147 samples), from five different EDs. The incidence of injury in study 1 was higher with the OCD hs-cTnI assay (30.9%; 95% CI: 26.9 to 35.2) compared to that of the Abbott hs-cTnI (17.3%; 95% CI: 14.1 to 21.0) and the OCD cTnI ES (15.4%; 95% CI: 12.4 to 18.9) assays, with repeat testing identifying 4.8% (95% CI: 3.0 to 7.5) of the OCD hs-cTnI results with poor reproducibility. In study 2, 4.6% (95% CI: 3.5 to 6.0) of the results were not reported for the OCD hs-cTnI assay (i.e., poor reproducibility) with 12.7% (95%CI: 8.7 to 17.8) of the OCD hs-cTnI results positive for injury being negative for injury with the Abbott hs-cTnI assay. In summary, the OCD hs-cTnI assay yields higher rates of biochemical injury with a higher rate of poor reproducible results in different ED populations.
Highlights
In the emergency setting, physicians will order a cardiac troponin test on patients presenting with symptoms suggestive of acute coronary syndrome (ACS) in order to rule-in or rule-out acute myocardial infarction
The percentage of injury in this group (n = 84) was 55.9% for the Ortho Clinical Diagnostics (OCD) hs-cTnI assay as compared to only 22.6% with the Abbott hs-cTnI assay (p < 0.01)
Removal of these 84 samples increased the correlation between OCD hs-cTnI and Abbott hs-cTnI and yielded the following equation: OCD = 0.72 × Abbott hs-cTnI + 0.3 (n = 327) (Figure 2)
Summary
Physicians will order a cardiac troponin (cTn) test on patients presenting with symptoms suggestive of acute coronary syndrome (ACS) in order to rule-in or rule-out acute myocardial infarction. For newer versions of cTn tests, such as the highsensitivity cardiac troponin (hs-cTn) assays, both analytical and clinical studies are required to verify their performance. Both diagnostic and prognostic studies in patients presenting with symptoms suggestive ACS in the emergency department (ED) are important for obtaining regulatory approval and supporting clinical adoption of newer tests such as the Ortho Clinical Diagnostics (OCD) hs-cTnI assay [1,2,3,4,5]. ACS, tachyarrhythmias, and heart failure [6] Within these elevated hs-cTnI samples, a small percentage of elevations are due to analytical issues/interferences, which are problematic for both the clinical and laboratory staff [7,8,9,10,11,12].
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