혈청 검체에 대한 Optical Q Troponin T 현장검사의 성능 평가: Roche Elecsys Troponin T hs 검사와의 비교 연구
Performance evaluation of Optical Q Troponin T point-of-care testing for serum specimen: A comparative study with the Roche Elecsys Troponin T hs assay
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연구목적: 기존 심근 troponin의 자동화 장비 기반 검사는 의료자원이 제한적인 상황에서 활용이 어렵고, 이러한 측면 에서 정확도가 보장되는 현장검사는 유용하게 사용 가능하다. 본 연구에서는 현장진단 검사인Optical Q Troponin T 검사의 성능을 기존 검사인 Roche Elecsys Troponin T hs 검사와 비교하여 분석하고자 하였다. 대상 및 방법: 2024년 6월부터 9월까지 충북대학교병원 진단검사의학과에 troponin T 검사가 의뢰된 검사대상자의 잔여검 체 432개를 분석하였다. Optical Q Troponin T 검사 결과를 충북대학교병원과 옵티바이오 검사실에서 각각 시행한 Elecsys Troponin T hs 검사 결과와 비교하여 상관성 분석을 시행하였다. 결과: Optical Q Troponin T 검사와 옵티바이오 검사실에서 시행한 Elecsys Troponin T hs 검사는 전체 일치도 97.68%, 양성 일치도 98.88%, 음성 일치도 95.73%, κ = 0.95로 높은 일치도를 보였으며 선형 회귀분석에 서 R2 = 0.9864로 우수한 상관성을 보였다. 충북대학교병원 검사실 결과와도 유사한 결과를 나타냈다(전체 일치도 97.68%, 양성 일치도 98.51%, 음성 일치도 96.29%, κ = 0.95, R2 = 0.9911). 결론: Optical Q Troponin T 검사는 기존에 보편적으로 사용되는 자동화 장비 기반 검사법과 비교하여 높은 상 관성을 보였으며, 현장진단 검사로서 경제성과 편리성을 갖추고 있어 급성 심근경색의 신속한 진단에 유용 하게 활용될 수 있을 것으로 기대된다.
Abstract
Purpose: A conventional cardiac troponin assay based on automated instruments is difficult to utilize in situations with limited medical resources. In this respect, point-of-care testing with guaranteed accuracy can be highly useful. The aims of this study were to assess the performance of the Optical Q Troponin T point-of-care testing by comparing it with the conventional Roche Elecsys Troponin T hs assay. Materials and methods: We analyzed 432 leftover specimens from patients who underwent troponin T testing at Chungbuk National University Hospital between June and September 2024. Correlation analyses were conducted by comparing the results of the Optical Q Troponin T test with those of the Elecsys Troponin T hs test performed at both Chungbuk National University Hospital and Optibio laboratories. Results: The Optical Q Troponin T test showed high agreement with the Elecsys Troponin T hs test performed at the Optibio laboratory, with an overall agreement rate of 97.68%, positive agreement rate of 98.88%, negative agreement rate of 95.73%, and κ = 0.95. Linear regression analysis showed excellent correlation with R2 = 0.9864. Similar results were observed with the Chungbuk National University Hospital laboratory results. Conclusion: The Optical Q Troponin T test showed high correlation compared to the the Roche Elecsys Troponin T hs assay. Its cost-effectiveness and convenience as a point-of-care test make it a promising tool for the rapid diagnosis of acute myocardial infarction.
참고문헌 (13)
- Virani SS, "Heart Disease and Stroke Statistics-2021 Update : A Report From the American Heart Association", Circulation, 143, pp.e254~743 (2021)[DOI]
- Kim JH, "Multicenter Cohort Study of Acute Myocardial Infarction in Korea-Interim Analysis of the Korea Acute Myocardial Infarction Registry-National Institutes of Health Registry", Circ J, 80, pp.1427~1436 (2016)[DOI]
- Collet JP, "2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation", Eur Heart J, 42, pp.1289~1367 (2021)[DOI]
- Thygesen K, "Fourth universal definition of myocardial infarction(2018)", Eur Heart J, 40, pp.237~269 (2019)[DOI]
- Apple FS, "Analytical characteristics of high-sensitivity cardiac troponin assays", Clin Chem, 58, pp.54~61 (2012)[DOI]
- Reddy K, "Recent advances in the diagnosis and treatment of acute myocardial infarction", World J Cardiol, 7, pp.243~276 (2015)[DOI]
- Katrukha IA, "Fragmentation of human cardiac troponin T after acute myocardial infarction", Clin Chim Acta, 542, pp.117281~ (2023)[DOI]
- "Point-of-Care Testing" (2023)[URL]
- Landis JR, "The measurement of observer agreement for categorical data", Biometrics, 33, pp.159~174 (1977)
- Cullen L, "Point-ofcare testing with high-sensitivity cardiac troponin assays : the challenges and opportunities", Emerg Med J, 39, pp.861~866 (2022)[DOI]
- Boeddinghaus J, "Early diagnosis of myocardial infarction with point-of-care high-sensitivity cardiac troponin I", J Am Coll Cardiol, 75, pp.1111~1124 (2020)[DOI]
- Sörensen NA, "Diagnostic evaluation of a high-sensitivity troponin I point-of-care assay", Clin Chem, 65, pp.1592~1601 (2019)[DOI]
- Yim J, "Application of the Analytical Performance Specification for Quality Management of Clinical Chemistry Tests", Lab Med Online, 13, pp.255~262 (2023)[DOI]