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Updated: Jan 26, 2026
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Analytical performance evaluation and reference limits establishment of a new chemiluminescence growth stimulation
Litao Zhang1, Chenbin Zhang1, Xin Shu1
1Clinical Laboratory of Wuhan Asia General Hospital, 432000 Wuhan, Hubei, China.
Background And Objectives:
Growth stimulation expressed gene 2 (ST2) is an established biomarker for assessing myocardial fibrosis and ventricular remodeling in heart disease. This study aimed to comprehensively evaluate the analytical performance of a novel chemiluminescent immunoassay (CLIA) for ST2 and to establish its reference limits.
Methods:
Analytical performance, including precision, detection capability, linearity, interference, and sample type correlation, was validated according to CLSI guidelines. A method comparison was conducted with the Presage ST2 ELISA (Critical Diagnostics). Sex-specific 99th percentile upper reference limits (URLs) were established from 1592 healthy adults.
Results:
The ST2 (CLIA) assay demonstrated high precision, with both repeatability and reproducibility CVs < 5%. The limits of blank (LoB), detection (LoD), and quantitation (LoQ) were within the claimed specifications. The assay showed excellent linearity from 2.00 to 2000 ng/mL (r > 0.99). No significant interference was observed, and correlations between different sample types were high (r > 0.99). Method comparison with the Presage ST2 assay yielded a regression equation of y = 1.0365x - 1.9307 (r = 0.9760). The 99th percentile URLs were 42.3 ng/mL for males, 36.2 ng/mL for females, and 37.7 ng/mL for the overall cohort.
Conclusions:
The Mindray ST2 chemiluminescent immunoassay exhibits robust analytical performance, meeting the demands of clinical practice with high precision, sensitivity, and specificity. The established reference intervals support its application for precise patient stratification.
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