Multicenter reference limits of hs-cTnI and NT-proBNP in a Chinese cohort.
This study aimed to validate the analytical performance of high-sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) assays, and to establish age- and sex-specific reference intervals (RIs) using a large multicenter Chinese cohort.
hs-cTnI and NT-proBNP were measured on a fully automated chemiluminescence platform (Maglumi X8, Snibe, China). Analytical performance was validated following Clinical and Laboratory Standards Institute guidelines. Sex- and age-specific RIs for hs-cTnI (n=2,323) and NT-proBNP (n=2,333) were determined nonparametrically from IFCC-compliant cohorts across six Chinese provinces.
Analytical validation confirmed high sensitivity, specificity, satisfactory linearity, and strong interference resistance of hs-cTnI and NT-proBNP. hs-cTnI demonstrated 3.19 % total imprecision near 99th percentile URLs and >99.5 % detectable rates (>LoD) in healthy individuals, meeting third-generation hs-cTn criteria. RIs were established stratified by age and sex. In plasma, RIs of hs-cTnI were 11.97 ng/L for males and 11.61 ng/L for females, while 97.5th percentile URLs of NT-proBNP were 145.00 ng/L overall, 113.63 ng/L for males, and 160.75 ng/L for females. Elevated hs-cTnI levels were observed in residents of Ningxia and in women with central obesity.
The Snibe hs-cTnI assay fulfills IFCC high-sensitivity criteria. Age- and sex-specific RIs of hs-cTnI and NT-proBNP were established from a large multicenter Chinese cohort, confirming their essential role in accurate cardiovascular risk stratification.
hs-cTnI and NT-proBNP were measured on a fully automated chemiluminescence platform (Maglumi X8, Snibe, China). Analytical performance was validated following Clinical and Laboratory Standards Institute guidelines. Sex- and age-specific RIs for hs-cTnI (n=2,323) and NT-proBNP (n=2,333) were determined nonparametrically from IFCC-compliant cohorts across six Chinese provinces.
Analytical validation confirmed high sensitivity, specificity, satisfactory linearity, and strong interference resistance of hs-cTnI and NT-proBNP. hs-cTnI demonstrated 3.19 % total imprecision near 99th percentile URLs and >99.5 % detectable rates (>LoD) in healthy individuals, meeting third-generation hs-cTn criteria. RIs were established stratified by age and sex. In plasma, RIs of hs-cTnI were 11.97 ng/L for males and 11.61 ng/L for females, while 97.5th percentile URLs of NT-proBNP were 145.00 ng/L overall, 113.63 ng/L for males, and 160.75 ng/L for females. Elevated hs-cTnI levels were observed in residents of Ningxia and in women with central obesity.
The Snibe hs-cTnI assay fulfills IFCC high-sensitivity criteria. Age- and sex-specific RIs of hs-cTnI and NT-proBNP were established from a large multicenter Chinese cohort, confirming their essential role in accurate cardiovascular risk stratification.
Authors
Xu Xu, Li Li, Xie Xie, Hou Hou, Xu Xu, Cui Cui, Chen Chen, Zhang Zhang, Peng Peng, Zhou Zhou, Wang Wang
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