BACKGROUND: As new high-sensitivity (hs) cardiac troponin (cTn) assays are introduced decision limits, based on the 99th percentile upper reference limit (99 percentile URL), for each method must be determined and from a sufficiently large cohort to mitigate against distortionary effects of high-end outliers. There is a paucity of studies with large multi-ethnic cohorts. METHODS: We determined the 99 percentile URL in 1120 (mean age: 50.4±8.2 y) apparently healthy (no history of diabetes, hypertension, heart, lung, or renal disease) Asians (597 men aged 35-65 y, 523 women aged 40-65 y) in a pre-market hs-cTnI assay (Abbott Diagnostics). RESULTS: Hs-cTnI performance was: limit of blank - 0.6 ng/l, limit of detection (LoD) - 1.5 ng/l; cTnI inter-assay coefficient of variation of 20% and 10% were 1.5 and 6.0 ng/l respectively. Hs-cTnI concentrations (range: 0-49.3 ng/l) were detectable (>assay LoD) in 92.3% of participants, and higher in men and individuals >50 y. All-subject, male, and female 99 percentile URL (90% CI) were 25.6 (19.6-32.6), 32.7 (21.1-47.9) and 17.9 (10.7-26.3) ng/l respectively. CONCLUSION: This hs-cTnI assay exhibits hs performance besides gender and age differences. The all-subject 99 percentile URL values are similar to those reported from some groups but not in others. Users need to establish their own decision limits.
BACKGROUND: As new high-sensitivity (hs) cardiac troponin (cTn) assays are introduced decision limits, based on the 99th percentile upper reference limit (99 percentile URL), for each method must be determined and from a sufficiently large cohort to mitigate against distortionary effects of high-end outliers. There is a paucity of studies with large multi-ethnic cohorts. METHODS: We determined the 99 percentile URL in 1120 (mean age: 50.4±8.2 y) apparently healthy (no history of diabetes, hypertension, heart, lung, or renal disease) Asians (597 men aged 35-65 y, 523 women aged 40-65 y) in a pre-market hs-cTnI assay (Abbott Diagnostics). RESULTS: Hs-cTnI performance was: limit of blank - 0.6 ng/l, limit of detection (LoD) - 1.5 ng/l; cTnI inter-assay coefficient of variation of 20% and 10% were 1.5 and 6.0 ng/l respectively. Hs-cTnI concentrations (range: 0-49.3 ng/l) were detectable (>assay LoD) in 92.3% of participants, and higher in men and individuals >50 y. All-subject, male, and female 99 percentile URL (90% CI) were 25.6 (19.6-32.6), 32.7 (21.1-47.9) and 17.9 (10.7-26.3) ng/l respectively. CONCLUSION: This hs-cTnI assay exhibits hs performance besides gender and age differences. The all-subject 99 percentile URL values are similar to those reported from some groups but not in others. Users need to establish their own decision limits.
Authors: Muhammad Hammadah; Ibhar Al Mheid; Kobina Wilmot; Ronnie Ramadan; Ayman Alkhoder; Malik Obideen; Naser Abdelhadi; Shuyang Fang; Ijeoma Ibeanu; Pratik Pimple; Heval Mohamed Kelli; Amit J Shah; Brad Pearce; Yan Sun; Ernest V Garcia; Michael Kutner; Qi Long; Laura Ward; J Douglas Bremner; Fabio Esteves; Paolo Raggi; David Sheps; Viola Vaccarino; Arshed A Quyyumi Journal: JACC Cardiovasc Imaging Date: 2017-03-15
Authors: Lori B Daniels; Paul Clopton; Christopher R deFilippi; Otto A Sanchez; Hossein Bahrami; Joao A C Lima; Russell P Tracy; David Siscovick; Alain G Bertoni; Philip Greenland; Mary Cushman; Alan S Maisel; Michael H Criqui Journal: Am Heart J Date: 2015-09-28 Impact factor: 4.749
Authors: Brendan M Everett; Tanja Zeller; Robert J Glynn; Paul M Ridker; Stefan Blankenberg Journal: Circulation Date: 2015-03-30 Impact factor: 29.690
Authors: Anoop S V Shah; Megan Griffiths; Kuan Ken Lee; David A McAllister; Amanda L Hunter; Amy V Ferry; Anne Cruikshank; Alan Reid; Mary Stoddart; Fiona Strachan; Simon Walker; Paul O Collinson; Fred S Apple; Alasdair J Gray; Keith A A Fox; David E Newby; Nicholas L Mills Journal: BMJ Date: 2015-01-21
Authors: Vera J Goh; Thu-Thao Le; Jennifer Bryant; Jia Ing Wong; Boyang Su; Chi-Hang Lee; Chee Jian Pua; Chloe P Y Sim; Briana Ang; Tar Choon Aw; Stuart A Cook; Calvin W L Chin Journal: Circ Cardiovasc Imaging Date: 2017-09 Impact factor: 7.792
Authors: Jack Wei Chieh Tan; Carolyn S P Lam; Sazzli Shahlan Kasim; Tar Choon Aw; Joel M Abanilla; Wei-Ting Chang; Van Phuoc Dang; Maria Iboleon-Dy; Sari Sri Mumpuni; Arintaya Phommintikul; Manh Cuong Ta; Punkiat Topipat; Kai Hang Yiu; Louise Cullen Journal: Heart Asia Date: 2017-04-07
Authors: Muhammad Hammadah; Jeong Hwan Kim; Ayman Samman Tahhan; Bryan Kindya; Chang Liu; Yi-An Ko; Ibhar Al Mheid; Kobina Wilmot; Ronnie Ramadan; Ayman Alkhoder; Fahad Choudhary; Mohamad Mazen Gafeer; Naser Abdelhadi; Pratik Pimple; Pratik Sandesara; Bruno B Lima; Amit J Shah; Laura Ward; Michael Kutner; J Douglas Bremner; David S Sheps; Paolo Raggi; Laurence S Sperling; Viola Vaccarino; Arshed A Quyyumi Journal: Ann Intern Med Date: 2018-11-06 Impact factor: 25.391