Determination of high‐sensitivity cardiac troponin T upper reference limits under the improved selection criteria in a Chinese population. Issue 1 (16th August 2019)

• Record Type: Journal Article
• Authors: Zhang, Xin; Han, Xiaoxu; Zhao, Min; Mu, Runqing; Wang, Shuo; Yun, Ke; Shang, Hong
• Is Part Of: Journal of clinical laboratory analysis. Volume 34:Issue 1(2020)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2019-08-16
• Subjects: 99th percentile -- high‐sensitivity cardiac troponin T -- reference population -- selection criteria; Diagnosis, Laboratory -- Periodicals; Medical laboratory technology -- Periodicals; 616
• DOI: 10.1002/jcla.23007
• Languages: English
• ISSNs: 0887-8013

Abstract

Abstract: Background: There is no common consensus on how to define the reference population for determination of high‐sensitivity cardiac troponin (hs‐cTn) upper reference limit (URL). This study aimed to establish 99th percentile URLs of hs‐cTnT under both 2018 AACC/IFCC criteria and improved selection criteria for further judging whether two URLs are different. Methods: Applying the stratified cluster sampling protocol, this study took 1848 apparently healthy subjects in communities of Shenyang China as the screening objects. We first followed 2018 AACC/IFCC criteria using surrogate biomarker for diabetes, myocardial dysfunction, renal dysfunction, and electrocardiogram. Then, we followed improved selection criteria to exclude hypertension, overweight and obesity, and dyslipidemia by physical examination and laboratory screening. Accordingly, 99th percentile URLs of hs‐cTnT were established. Results: If the 2018 AACC/IFCC criteria were applied, 99th percentile URLs (90% confidence interval) of hs‐cTnT male, female, and total were 19 (17‐20) ng/L, 16 (15‐17) ng/L, and 18 (16‐19) ng/L, respectively. If added a single supplementary selection criteria, 99th percentile URLs of hs‐cTnT total reduced to 16 ng/L, 17 ng/L, and 16 ng/L, respectively. If the improved selection criteria were applied, 99th percentile URLs (90% confidence interval) of hs‐cTnT male, female, and total were 18 (14‐24) ng/L, 13 (11‐16) ng/L, and 16 (13‐17) ng/L, respectively. The 99th percentile URLs of hs‐cTnT male were higher than those of female in every age group. Conclusions: Improved selection criteria through questionnaire survey, physical examination, and laboratory screening to further exclude hypertension, overweight and obesity, and dyslipidemia can avoid overestimation of the 99th percentile URL of hs‐cTnT.