Citations 2
Improving Care by FAster risk-STratification through use of high sensitivity point-of-care troponin in patients presenting with possible acute coronary syndrome in the EmeRgency department (ICare-FASTER): a stepped-wedge cluster randomized trial
Than, Martin , Pickering, John W. , Buchan, Vanessa A, Florkowski, Christopher M , Mills, Nicholas L. , Hamill, Laura , Prystowsky, Jason, Harger, Simon, Reed, Mary, Bayless, Jared, Feberwee, Alexander, Attenburrow, Tamsin, Norman, Timothy, Welfare, Oliver, Heiden, Tamika L., Kavsak, Peter, Jaffe, Allan S. , Apple, Fred S. , Cullen, L, Aldous, Sally, Frampton, Christopher MA, Body, Richard, Lord, Sarah Jane, George, Peter Myles, Devlin, Gerard, Kavsak, Peter A. , Mills, Nicholas L , Than, Martin , Pickering, John W , Joyce, Laura R, Buchan, Vanessa, Florkowski, Christopher M , Hamill, Laura, Prystowsky, Jason, Harger, Simon, Reed, Mary, Bayless, Jared, Feberwee, Alexander, Attenburrow, Tamsin, Norman, Timothy, Welfare, Oliver, Heiden, Tamika, Kavsak, Peter , Jaffe, Allan S. , Apple, Fred S. , Peacock, William Frank , Cullen, Louise , Aldous, Sally, Richards, Arthur M , Lacey, Cameron, Troughton, Richard W , Frampton, Christopher, Body, Rick , Mueller, Christian , Lord, Sarah, George, Peter M, Devlin, Gerard
No container title available | April 23, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available
ABSTRACT BACKGROUND Point-of-care (POC) high-sensitivity cardiac troponin (hs-cTn) testing has the potential to expedite decision-making and reduce emergency department (ED) length of stay for patients presenting with possible myocardial infarction (MI) by ensuring that results are consistently available when looked for by clinicians. We assessed the real-life effectiveness and safety of implementing POC hs-cTn testing in the ED. METHODS We conducted a pragmatic, stepped-wedge cluster randomized trial. The control arm was usual care with an accelerated diagnostic pathway utilizing a single-sample rule-out step with a central laboratory hs-cTn assay. The intervention arm used the same pathway with a POC hs-cTnI. The primary effectiveness outcome was ED length of stay assessed using a generalized linear mixed model, and the safety outcome was 30-day MI or cardiac death. RESULTS Six sites participated with 59,980 ED presentations (44,747 individuals, 61±19 years, 49.5% female) from February 2023 to January 2025, in which 31,392 presentations were during the intervention arm. After adjustment for co-variates associated with length of stay, the intervention reduced length of stay by 13% (95% confidence intervals [CI], 9 to 16%. P<0.001), corresponding to a reduction of 47 minutes (95%CI, 33 to 61 minutes) from a mean length of stay in the control arm of 376 minutes. The 30-day MI or cardiac death rate was similar in the control and intervention arms (0.39% and 0.39% respectively, P=0.54). CONCLUSIONS Implementation of whole-blood hs-cTnI testing at the POC into an accelerated diagnostic pathway was safe and reduced length of stay in the ED compared with laboratory testing. (Australia New Zealand Clinical Trials Registry ACTRN12619001189112) Clinical Perspective What is new? Point-of-care troponin assays with good precision have become available and received regulatory approval as high-sensitivity assays. A pragmatic stepped-wedge cluster randomized trial implementing the validated Siemens VTLi high-sensitivity point-of-care assay into 6 emergency departments investigating ∼60,000 patients, was conducted to ascertain if the rapid turnaround time reduced lengths of stay. Introduction of the VTLi high-sensitivity point-of-care assay into clinical pathways reduced emergency department lengths of stay by an average 13% (47 minutes) without compromising safety. What are the clinical implications? Early decision-making using a point-of-care high-sensitivity troponin assay within a structured clinical pathway was safe. Faster turnaround means troponin results are consistently available when clinicians first seek them. This can facilitate earlier decisions and reduce patient length of stay.
Establishing Reference Values in Healthy Participants for the Cardiac Troponin T High-Sensitivity Gen 6 Assay: REF-TSIX Global Reference Study
Daniels, Lori B. , Mueller, Christian, Giannitsis, Evangelos, Meex, Steven J. R., Buehlmann, David, Dilba, Peter, Bendig, Garnet, Cole, Mette, Body, Richard, Christenson, Robert H, deFilippi, Christopher R, Inoue, Kenji, Jaffe, A S, McCarthy, Cian P. , McCord, J., Neumann, Johannes T, Omland, T., Papendick, Cynthia , Sandoval, Yader, Twerenbold, Raphael, Peacock, W Frank, Mills, Nicholas L, investigators, the TSIX, Jacobs, Michael B., Lucksinger, Gregg, Powell, Richard, Johnson, Daniel, Coleman, Hugh, Fein, M, Surber, Joseph, Vu, Jack B., Hassman, Michael, Hernandez, John, Kirstein, Judith, Tomaszewski, Christian, Runyon, Michael S. , Gong, Jonathan , Wein, D., Andrabi, Sara , Kopin, David , Larrain, Germain, Tahirkheli, Naheem, Clemency, Brian, Abdullah, Shuaib, Hira, Ravi S. , Klausner, H A, Mahler, Simon A. , Crystal, Chad, Headden, Gary, Chaille, Peter, Cannon, Chad Aaron, Limkakeng, Alexander, Tolia, Vaishal , Knapp, Barry J., Massoomi, Mohammad, Sandoval, Yader, Ko, Emily, Luzzi, Verónica, Christenson, Robert, Carson, Jennifer Powers , Cacioppo, F , Kolev, E., Petrov, Andrey, Hazarbasanov, Dobri , Simova, lana, Magimaiseelan, Luci Suganthi, Kosch, Christine, Klein, G, Mehltretter, Kai, Sauter, Joachim, Baumann, Sybille, Moeckel, Martin, Twerenbold, Raphael, Muller-Hennessen, Matthias, Biener, Moritz , Findeisen, P., Omland, Torbjøm, Wilczek-Kosowska, Urszula, Zimmer-Satora, Ewa, Krecipro-Nizińska, Ewa, Miró, O, Díaz, Víctor Jiménez , Mueller, C, Christ, Michael, Lynch, Stephen, BODY, R. A. F., Matsuki, Shunji, Eto, Takashi, Tanaka, Takanori, Hanada, Ryuzo, Nakagami, Takuo, Nakama, T, Kadota, K., Jing, Shan, Yu, Shuwen, Zhang, Hongxuan, Zhang, Jun, Huo, Yong, Zhang, Yan, Yan, Li, Jiang, Longyuan, Chen, Weiqiang, Huang, Jianying, Zhao, Yan, Guan, Ling, Yang, Yanhua, Zhang, Qin, Qiu, Zhaohui, Body, Richard , Neumann, Franz–Josef , Müller, Christian , Mueller, Christian , Body, Rick , Eggers, Kai M. , Jaffe, Allan S. , Neumann, Johannes T , Sandoval, Yader , Tan, Jack Wei Chieh , Than, Martin , Twerenbold, Raphael , Mills, Nicholas L , Daniels, Lori B , Giannitsis, Evangelos , Meex, Steven J.R. , Christenson, Robert H. , Cobbaert, Christa M. , deFilippi, Christopher R. , McCord, James , Omland, Torbjørn , Sandoval, Yader , Tan, Jack Wei Chieh , Than, Martin , Twerenbold, Raphael , Surber, Joseph, Tomaszewski, Christian, Clemency, Brian, Headden, Gary , Cannon, Chad, Knapp, Barry , Tran, Nam K , Niederdöckl, Jan Daniel , Kolev, Emil, Popov, Todor, Sauter, Joachim, Baumann, Sybille , Möeckel, Martin , Müller‐Hennessen, Matthias, Findeisen, Peter, Scharnhorst, Volkher , Omland, T, Krecipro-Nizińska, Ewa, Christ, Michael , Nakagami, Takuo, Huo, Yong
Clinical Chemistry | January 18, 2026 | Volume: 72 | Issue: 4 | Pages: 488-502
Abstract Background Measurement of cardiac troponin (cTn) using high-sensitivity assays is recommended for the diagnosis of myocardial infarction. We determined sex-specific and uniform 99th percentile upper reference limits (URLs) using the new Elecsys® Troponin T high-sensitivity Gen 6 assay in a global, healthy reference range cohort. Methods Lithium-heparin plasma and serum samples were prospectively collected from apparently healthy individuals aged ≥20 years across 34 global sites in the United States, Europe, China, and Japan. cTnT was measured using the Troponin T high-sensitivity Gen 6 assay on the Cobas® e 801 analyzer. Exclusion criteria were defined according to the 2022 IFCC guidance. Uniform and sex-specific 99th percentile URLs and nonparametric 95% CIs were determined in plasma and serum separately and combined. Results The final study population comprised 4147 participants (52.5% female) with a median (25th–75th percentiles) age of 48.0 (33.0–59.0) years; 45.8%, 47.9%, 5.2%, and 1.1% were White, Asian, Black, and other/unknown, respectively. For sample matrices combined (n = 8294), 81.0% and 99.2% of cTnT values were above the limit of detection in females and males, respectively. Sex-specific 99th percentile URLs (95% CI) were 18 (16–23) ng/L for females and 32 (28–35) ng/L for males; the uniform 99th percentile URL was 27 (24–31) ng/L. URLs were comparable in plasma and serum samples. Conclusions This study determined sex-specific and uniform 99th percentile URLs for the Troponin T high-sensitivity Gen 6 assay that were comparable irrespective of the matrix used in a large, global, healthy reference population.