AbstractOver the period from December 3rd, 2019 to March 13th, 2020, after the urgent field safety notice reported by Roche, we performed double determinations of all troponins from the same tube in parallel and in the same run. We used the same Elecsys troponin T hs reagent (ref 08469873190), first result was obtained with the current hs-cTnT application (18 min) and the second measurement was with the STAT application (9 min). On the 11,388 results in the range from 3 to 500 ng/L, we observed 4.18% discordant results (above 18.8% RCV). Overall, we observed an overestimation of the hs-cTnT STAT assay. The Elecsys Troponin T hs STAT assay demonstrated good analytical performances on Cobas e801 analyzer. However, its use according to the ESC recommendations for the 0 h/1 h algorithm should be carefully evaluated and requires further studies with serial cTn testing.
Regulatory Autonomy under the WTO Agreement on Sanitary and Phytosanitary Measures: Implications of Korea – Import Bans, and Testing and Certification Requirements for Radionuclides — ERRATUM
