A-002 Analytical Validation of the Zybio High Sensitivity Cardiac Troponin I CLIA Assay

Abstract

Abstract Background High-sensitivity cardiac troponin (hs-cTn) plays a pivotal role in the early diagnosis of Acute Coronary Syndrome (ACS). With technological advancements, the sensitivity of troponin assays has significantly improved. The International Federation of Clinical Chemistry (IFCC) criteria for hs-cTn assays include a total imprecision (Coefficient of Variation, CV) ≤10% at the gender-specific 99th percentile value and detectable levels in ≥50% of a healthy population. This study aims to evaluate the performance of Zybio's hs-cTnI assay against these high-sensitivity standards Methods This study involved 1661 individuals undergoing routine health checks at Chongqing Medical University Third Hospital. Exclusion criteria included recent medication use, abnormal NT-proBNP levels, significant cardiac silhouette changes in chest X-rays, age <20, incomplete data, pregnancy, or history of severe chronic diseases. Participants were classified into apparent healthy and healthy groups based on blood pressure, lipid profiles, and electrocardiogram results. Laboratory examinations included hs-cTn and NT-ProBNP concentrations using Zybio's chemiluminescence instrument EXI2400 and associated reagent kits, with other parameters measured using standard biochemical and high-performance liquid chromatography methods. Results Of the 1247 participants (556 males, 691 females) included in the final analysis, 1157 showed detectable hs-cTnI levels above the limit of detection (LOD), yielding an overall detection rate of 92.78%. Detection rates were 93.71% in males and 92.04% in females. The total imprecision (CV) of hs-cTnI at gender-specific 99th percentile values over 20 days was below 10%, meeting the high-sensitivity criteria. This finding was consistent across lower and higher concentration ranges. Conclusions The Zybio hs-cTnI assay demonstrated a high detection rate in a healthy population, with 92.78% detectability overall, 93.71% in males, and 92.04% in females. The assay met the high-sensitivity criteria of IFCC, with a total imprecision (CV) of less than 10% at the gender-specific 99th percentile levels. These results validate the utility of Zybio's hs-cTnI assay for clinical application in the early diagnosis of ACS.