Clinical Implications of a Recent Adjustment to the High-Sensitivity Cardiac Troponin T Assay: User Beware

[摘要] To the Editor:Roche Diagnostics recently issued a technical bulletin calling for an adjustment to the calibration curve for the Elecsys Troponin T hs and Elecsys Troponin T hs STAT assays. Although this bulletin was disseminated widely in some countries, it was less widely distributed in others. The Roche high-sensitivity (hs) assays are in clinical use worldwide except within the US, where they are used for research but have not yet been cleared by the Food and Drug Administration. Roche has characterized this action as a “minor adjustment” to the low-end standardization of the Troponin T hs assays in order to return to the original assay specifications. The new revised lots (numbers 167345 and 167650) yield measurable cardiac troponin T concentrations in hs assays in a greater proportion of patient samples for which the concentrations were undetectable with previous lots [163704 (Troponin T hs) and 164773 (Troponin T hs STAT)] and older lots (6 lots total). Specifically, Roche has indicated that the new lots will produce higher recoveries at low concentrations (3–20 ng/L) and produce a shift upward—as much …

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