Clinical performance validation and four diagnostic strategy assessments of high-sensitivity troponin I assays
Abstract Acute coronary syndrome (ACS) includes conditions such as unstable angina (UA), non-ST elevation myocardial infarction (NSTEMI), and ST elevation myocardial infarction (STEMI). High-sensitivity cardiac troponin I (hs-cTnI) assays have been recommended as primary biomarkers for NSTEMI diagno...
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Nature Portfolio
2025-04-01
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| Online Access: | https://doi.org/10.1038/s41598-025-99273-5 |
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| author | Junyi Wu Yaotong Hua Yilin Ge Ke Chen Siyu Chen Jiashu Yang Hui Yuan |
| author_facet | Junyi Wu Yaotong Hua Yilin Ge Ke Chen Siyu Chen Jiashu Yang Hui Yuan |
| author_sort | Junyi Wu |
| collection | DOAJ |
| description | Abstract Acute coronary syndrome (ACS) includes conditions such as unstable angina (UA), non-ST elevation myocardial infarction (NSTEMI), and ST elevation myocardial infarction (STEMI). High-sensitivity cardiac troponin I (hs-cTnI) assays have been recommended as primary biomarkers for NSTEMI diagnosis due to their high sensitivity and specificity. However, there is no consensus on the optimal diagnostic strategy for early NSTEMI detection. This study aims to evaluate the diagnostic performance of four hs-cTnI-based strategies for suspected NSTEMI: Limit of Detection (LoB), Single Cut-off, hs-cTnI 0/1 h Algorithm, and hs-cTnI 0/2 h Algorithm, in a Chinese cohort and compare the performance of assays from different manufacturers. Performance verification was conducted, including LoB, LoD, LoQ, and precision analysis. Clinical samples from 267 ACS patients were analyzed using Hybiome hs-cTnI assays. Diagnostic accuracy was assessed based on sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score. The LoB strategy demonstrated 100% sensitivity but low PPV (14.0%). Both the hs-cTnI 0/1 h Algorithm and hs-cTnI 0/2 h Algorithm showed high diagnostic performance, with the 0/2 h algorithm providing the best overall. 89.0% accuracy, 93.3% sensitivity, and 73.68% F1-score. The hs-cTnI 0/2 h Algorithm offers the most reliable diagnostic performance for early NSTEMI diagnosis. |
| format | Article |
| id | doaj-art-3e1dcf3853bd445fb1e4085d6d6418db |
| institution | DOAJ |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-04-01 |
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| spelling | doaj-art-3e1dcf3853bd445fb1e4085d6d6418db2025-08-20T03:14:03ZengNature PortfolioScientific Reports2045-23222025-04-011511810.1038/s41598-025-99273-5Clinical performance validation and four diagnostic strategy assessments of high-sensitivity troponin I assaysJunyi Wu0Yaotong Hua1Yilin Ge2Ke Chen3Siyu Chen4Jiashu Yang5Hui Yuan6Department of Laboratory Medicine, Beijing Anzhen Hospital, Capital Medical UniversityDepartment of Laboratory Medicine, Beijing Anzhen Hospital, Capital Medical UniversityDepartment of Laboratory Medicine, Beijing Anzhen Hospital, Capital Medical UniversityDepartment of Laboratory Medicine, Beijing Anzhen Hospital, Capital Medical UniversityDepartment of Laboratory Medicine, Beijing Anzhen Hospital, Capital Medical UniversityDepartment of Laboratory Medicine, Beijing Anzhen Hospital, Capital Medical UniversityDepartment of Laboratory Medicine, Beijing Anzhen Hospital, Capital Medical UniversityAbstract Acute coronary syndrome (ACS) includes conditions such as unstable angina (UA), non-ST elevation myocardial infarction (NSTEMI), and ST elevation myocardial infarction (STEMI). High-sensitivity cardiac troponin I (hs-cTnI) assays have been recommended as primary biomarkers for NSTEMI diagnosis due to their high sensitivity and specificity. However, there is no consensus on the optimal diagnostic strategy for early NSTEMI detection. This study aims to evaluate the diagnostic performance of four hs-cTnI-based strategies for suspected NSTEMI: Limit of Detection (LoB), Single Cut-off, hs-cTnI 0/1 h Algorithm, and hs-cTnI 0/2 h Algorithm, in a Chinese cohort and compare the performance of assays from different manufacturers. Performance verification was conducted, including LoB, LoD, LoQ, and precision analysis. Clinical samples from 267 ACS patients were analyzed using Hybiome hs-cTnI assays. Diagnostic accuracy was assessed based on sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and F1-score. The LoB strategy demonstrated 100% sensitivity but low PPV (14.0%). Both the hs-cTnI 0/1 h Algorithm and hs-cTnI 0/2 h Algorithm showed high diagnostic performance, with the 0/2 h algorithm providing the best overall. 89.0% accuracy, 93.3% sensitivity, and 73.68% F1-score. The hs-cTnI 0/2 h Algorithm offers the most reliable diagnostic performance for early NSTEMI diagnosis.https://doi.org/10.1038/s41598-025-99273-5NSTEMIhs-cTnIDiagnostic strategy |
| spellingShingle | Junyi Wu Yaotong Hua Yilin Ge Ke Chen Siyu Chen Jiashu Yang Hui Yuan Clinical performance validation and four diagnostic strategy assessments of high-sensitivity troponin I assays Scientific Reports NSTEMI hs-cTnI Diagnostic strategy |
| title | Clinical performance validation and four diagnostic strategy assessments of high-sensitivity troponin I assays |
| title_full | Clinical performance validation and four diagnostic strategy assessments of high-sensitivity troponin I assays |
| title_fullStr | Clinical performance validation and four diagnostic strategy assessments of high-sensitivity troponin I assays |
| title_full_unstemmed | Clinical performance validation and four diagnostic strategy assessments of high-sensitivity troponin I assays |
| title_short | Clinical performance validation and four diagnostic strategy assessments of high-sensitivity troponin I assays |
| title_sort | clinical performance validation and four diagnostic strategy assessments of high sensitivity troponin i assays |
| topic | NSTEMI hs-cTnI Diagnostic strategy |
| url | https://doi.org/10.1038/s41598-025-99273-5 |
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