Clinica chimica acta; international journal of clinical chemistry · 2026
Investigating non-reproducible high-sensitivity cardiac troponin T results in real-world practice.
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Evren Zeynep Şule, Uçar Kamil Taha
Аннотация
OBJECTIVES: High-sensitivity cardiac troponin T (hs-cTnT) testing is central to myocardial injury diagnosis, but non-reproducible ("outlier") results may complicate interpretation. Real-world data on their frequency and implications remain limited. We evaluated non-reproducible hs-cTnT results in our laboratory.
METHODS: This retrospective study at Başakşehir Çam and Sakura City Hospital used hs-cTnT measurements from June 2023-December 2025. Non-reproducible results were identified by a critical difference (CD)-based approach applied to repeat testing of original serum and lithium-heparin plasma specimens on a Roche cobas e801 platform (fifth-generation assay). The common change criteria (3C) served as an alternative classifier. Chi-square tests compared outlier rates between serum and plasma and between URL-triggered and delta-triggered subgroups. Directional changes on repeat and additional turnaround time were also assessed.
RESULTS: Among 10,815 repeated measurements, non-reproducible results occurred in 3.3% (n = 356; 95% CI 2.97-3.64). They were more frequent in plasma than in serum (5.4% vs. 0.7%, p < 0.001) and most common at initial concentrations of 10-20 ng/L (n = 223), followed by 20-30 ng/L (n = 92). Rates were 2.29% in URL-triggered and 3.87% in delta-triggered repeats (p < 0.001). On repeat, most results decreased (95.8%); increases were uncommon (4.2%). Repeat testing added a median delay of 42 min. The 3C criterion identified 425 results, comprising all CD-flagged cases plus 69 additional.
CONCLUSIONS: Non-reproducible hs-cTnT results occur with appreciable frequency and may be influenced by sample matrix and concentration range. Most represent isolated elevations decreasing on repeat, potentially affecting workflow and time-sensitive decisions. Selective repeat testing with careful interpretation may preserve analytical reliability while minimizing delays.
METHODS: This retrospective study at Başakşehir Çam and Sakura City Hospital used hs-cTnT measurements from June 2023-December 2025. Non-reproducible results were identified by a critical difference (CD)-based approach applied to repeat testing of original serum and lithium-heparin plasma specimens on a Roche cobas e801 platform (fifth-generation assay). The common change criteria (3C) served as an alternative classifier. Chi-square tests compared outlier rates between serum and plasma and between URL-triggered and delta-triggered subgroups. Directional changes on repeat and additional turnaround time were also assessed.
RESULTS: Among 10,815 repeated measurements, non-reproducible results occurred in 3.3% (n = 356; 95% CI 2.97-3.64). They were more frequent in plasma than in serum (5.4% vs. 0.7%, p < 0.001) and most common at initial concentrations of 10-20 ng/L (n = 223), followed by 20-30 ng/L (n = 92). Rates were 2.29% in URL-triggered and 3.87% in delta-triggered repeats (p < 0.001). On repeat, most results decreased (95.8%); increases were uncommon (4.2%). Repeat testing added a median delay of 42 min. The 3C criterion identified 425 results, comprising all CD-flagged cases plus 69 additional.
CONCLUSIONS: Non-reproducible hs-cTnT results occur with appreciable frequency and may be influenced by sample matrix and concentration range. Most represent isolated elevations decreasing on repeat, potentially affecting workflow and time-sensitive decisions. Selective repeat testing with careful interpretation may preserve analytical reliability while minimizing delays.