Key result
Subsequent lots of hs-cTnT reagent did not significantly change the prevalence of myocardial injury (≥14 ng/L) compared to the original lot (24-28% vs 27%, P>0.10), but increased values <5 ng/L.
Why the study?
Does the downward shift in subsequent lots of the hs-cTnT assay affect the prevalence of myocardial injury or the detection of low troponin concentrations in hospitalized patients?
Population
8,835 hs-cTnT results from a specific subgroup of hospitalized patients
Comparison
Subsequent lots of Roche hs-cTnT reagent… vs First lot of Roche hs-cTnT reagent not affected…
Design
Editorial
Authors
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The downward shift in certain lots of the Roche hs-cTnT assay primarily affects concentrations below the 99th percentile, potentially impacting rapid rule-out algorithms but not standard myocardial infarction diagnosis.
Does the downward shift in subsequent lots of the hs-cTnT assay affect the prevalence of myocardial injury or the detection of low troponin concentrations in hospitalized patients?
p-value: p=>0.10
The downward shift in certain lots of the Roche hs-cTnT assay primarily affects concentrations below the 99th percentile, potentially impacting rapid rule-out algorithms but not standard myocardial infarction diagnosis.
Kavsak et al. (2013) conducted a letter in Hospitalized patients (n=8,835). Subsequent lots of hs-cTnT reagent vs. Original lot (153401) was evaluated on Prevalence of myocardial injury (hs-cTnT concentrations ≥14 ng/L) (p=>0.10). Subsequent lots of hs-cTnT reagent did not significantly change the prevalence of myocardial injury (≥14 ng/L) compared to the original lot (24-28% vs 27%, P>0.10), but increased values <5 ng/L.
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