Key result
Various storage conditions maintain sixth-generation hs-cTnT stability in serum and plasma within maximum permissible deviations.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The sixth generation troponin T assay is actually able to more accurately predict which patients would go on to have cardiovascular disease, such as a heart attack or stroke, at a future date compared to older assays. So that's a very encouraging potential avenue for the future in identifying the people who're going to benefit from preventative treatment.”
“Our new test enables clinicians to detect even the smallest elevations in troponin levels – a critical biomarker for heart attack – with high confidence. This ensures that in a situation when every second counts, patients receive the life-saving care they need at the earliest opportunity, and emergency services can prioritise resources to deliver care effectively to those in urgent need.”
The novel sixth-generation high-sensitivity cardiac troponin T assay demonstrates stable performance across various storage conditions, supporting its regulatory approval and clinical utility.
BACKGROUND: High-sensitivity cardiac troponin T (hs-cTnT) assays must meet strict criteria prior to regulatory approval, as the test is central to myocardial infarction diagnosis. Evaluating analyte stability is essential for ensuring accurate results in stored samples. Here, cTnT stability using the novel sixth-generation assay was evaluated. We also discuss regulatory complexity. METHODS: From patients with acute coronary syndrome, serum and lithium heparin plasma (Li-Hep) were collected, pooled per matrix, and aliquoted. One aliquot was immediately analyzed (fresh) while the remainder was stored at ≤-60°C. Selected aliquots were thawed and measured (fresh-frozen) before transfer to 15-25°C for 3 and 5 h, or 2-8°C for 11 and 24 h. Long-term aliquots were transferred frozen to -15 to -25°C for ≥13 months or ≤-60 for 9 and ≥13 months. Measurements were performed in quadruplicate using the Elecsys® hs-cTnT Gen 6 assay on a Cobas® Pure analyzer (Roche Diagnostics). Recovery was calculated relative to fresh measurements. Maximum permissible differences (MPD) were ±1.2 ng/L, ±20%, and ±15% for cTnT concentrations <6 ng/L, ≥6-≤24 ng/L, and >24 ng/L, respectively, allowing one exceedance per condition. RESULTS: In total, >2000 measurements were performed in 18 distinct samples per matrix. Median cTnT concentrations were 49.3 ng/L (8.4-782) in Li-Hep and 49.8 ng/L (8.5-822) in serum. The observed deviation in recovery was below the MPD for all storage conditions and acceptance criteria were met. CONCLUSIONS: Stability of cTnT using the sixth-generation hs-cTnT test was demonstrated across different storage conditions for serum and Li-Hep.
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Diederiks et al. (2026) studied Acute coronary syndrome (n=18). Various storage conditions (temperature and duration) vs. Fresh measurements was evaluated on Deviation in recovery relative to fresh measurements. Stability of cTnT using the sixth-generation hs-cTnT test was demonstrated across different storage conditions for serum and lithium heparin plasma, with deviations below maximum permissible differences.
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