Abstract
Rapid rule-out pathways for myocardial infarction using high-sensitivity cardiac troponin depend on thresholds and time intervals
validated for a specific assay, yet these pathways are sometimes applied unchanged after a laboratory switches troponin
platforms. We review the assay-specific evidence behind the commonest 0/1-hour and 0/2-hour rule-out algorithms, the magnitude
of between-assay differences at the diagnostic decision limits these pathways use, and document a series of pathway-assay
mismatches identified across a hospital network following unannounced platform changes. Between-assay differences at the 99th
percentile upper reference limit ranged from 34% to 61% across four commonly used high-sensitivity troponin I and T assays, and
one network site continued applying a rule-out threshold validated for its previous assay for five months after switching platforms,
during which the pathway's negative predictive value could not be assured. We set out what a laboratory changing troponin assay
needs to revalidate, and propose a change-control checklist that ties any platform switch to a mandatory pathway threshold
review before the new assay goes live clinically.
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