Key result
High-sensitivity cardiac troponin assays from Abbott, Beckman Coulter, Siemens, and Roche demonstrated total precision under 7% and linearity, but showed only borderline comparability for classifying type 4a and 5 myocardial infarctions.
Why the study?
The study was conducted to compare selected analytical characteristics, the 99th percentile, and the comparability of 99th percentile multiples among high-sensitivity cardiac troponin assays.
Observational (n=220)
No
High-sensitivity troponin assays from different manufacturers show good analytical precision and linearity but are not interchangeable, which significantly affects the classification of type 4a and 5 myocardial infarctions.
Cl studie: Porovnat vybran charakteristiky stanoven kardilnch troponin vysoce senzitivnmi metodami hs-cTnI (Abbott, Beckman Coulter, Siemens) a hs-cTnT (Roche).Typ studie: Prospektivn studie clen na oven analytickch charakteristik, 99. percentilu a porovnatelnosti nsobk 99. percentilu.Nzev a sdlo pracovit: IKEM, Pracovit laboratornch metod, Praha.Materil a metody: Analytick systmy: Architect i2000 (Abbott), UniCel DxI 800 (Beckman Coulter), Cobas e801 (Roche) a ADVIA Centaur XP (Siemens). Diagnostick soupravy: STAT High Sensitive Troponin-I assay (Abbott, dle hs-cTnI Abbott), ACCESS hsTnI (Beckman Coulter, dle hs-cTnI Beckman Coulter), Elecsys hsTnT (STAT) (Roche, dle hs-cTnT Roche) a ADVIA Centaur TNIH (dle hs-cTnI Siemens). Linearita byla urena podle Krolla. Studie preciznosti probhla podle zkrcenho protokolu EP05-A2. Oven 99. percentilu bylo provedeno temi postupy: prvnm byl neparametrick odhad s 90% konfidennm intervalem s vylouenm odlehlch hodnot podle Reeda, druhm byl postup podle Harrella a Davise (jackknifed method) s vylouenm odlehlch hodnot podle Reeda a tetm byl neparametrick odhad 99. percentilu s urenm pouze doln meze 90% konfidennho intervalu. Oven porovnatelnosti nsobk 99. percentilu bylo provedeno na klinickch vzorcch pacient pomoc hodnocen shody (kappa statistika) v esti psmech nsobk 99. percentilu s ohledem na definici infarktu myokardu 4. a 5. typu.Vsledky: Celkov preciznost uren podle protokolu EP05-A2 nepeshla 7 % v irokm psmu koncentrac pro vechny tyi typy stanoven (hs-cTnI Abbott, hs-cTnI Beckman Coulter, hs-cTnT Roche a hs-cTnI Siemens). Linearita byla prokzna pro vechny tyi typy stanoven hs-cTn, ale v ppad hs-cTnT Roche lpe vyhovovala kvadratick funkce. Oven 99. percentilu (stanoveno pro hs-cTnI Abbott, hs-cTnI Beckman Coulter a hs-cTnT Roche) ukzalo vznamn rozdly mezi mui a enami a shodu s daji vrobce. Uren 99. percentilu podle Harrella a Davise s vylouenm odlehlch hodnot je monm zpsobem odhadu 99. percentilu pro situace s potem referennch jedinc nim ne doporuovanch 299 jedinc. Shoda nsobk 99. percentilu (stanoveno pro hs-cTnI Abbott, hs-cTnI Beckman Coulter a hs-cTnT Roche) ukzala lep statistickou shodu pro hs-cTnI Abbott a hs-cTnI Beckman Coulter, ale ni rove shody mezi hs-cTnI a hs-cTnT. Klasifikace infarktu typu 4a a 5 zvis na pouit diagnostick souprav.Zvr: Porovnnm vysoce senzitivnch metod stanoven troponin hs-cTnT (Roche) a hs-cTnI (Abbott, Beckman Coulter, Siemens) jsme ovili dostatenou preciznost stanoven a linearitu v irokm psmu koncentrac. Ovili jsme pohlavn rozdly na rovni 99. percentilu a monost pouit rznch statistickch nstroj pro vylouen odlehlch hodnot a uren 99. percentilu s intervalem spolehlivosti. Pro klasifikaci pacient s ohledem na definici infarktu myokardu 4. a 5. typu jsme nalezli pouze hranin shodu mezi jednotlivmi typy stanoven koncentrace cTn. Vsledky zjitn pouitmi diagnostickmi soupravami jsou analyticky spolehliv, avak nezamniteln. Klinick oprvnnost stanoven troponin vysoce senzitivnmi metodami, interpretace nzkch koncentrac nebo malch zmn (delta) koncentrac zskv v uvedench diagnostickch soupravch velmi robustn zklad.
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Jabor et al. (2019) conducted an observational in Healthy individuals (for reference limits) and cardiology patients (n=220). High-sensitivity cardiac troponin assays (hs-cTnI Abbott, Beckman Coulter, Siemens; hs-cTnT Roche) vs. Comparison among different assays was evaluated on Analytical precision, linearity, 99th percentile estimation, and comparability of 99th percentile multiples. High-sensitivity cardiac troponin assays from Abbott, Beckman Coulter, Siemens, and Roche demonstrated total precision under 7% and linearity, but showed only borderline comparability for classifying type 4a and 5 myocardial infarctions.
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