A comparative research of soluble ST2 determination by two different detection methods

Objective: The study in this paper is to evaluate the analytical performances of two soluble growth stimulating gene 2 protein (sST2) detection methods, and to observe the consistency of clinical application to provide a reference for the laboratory to select appropriate detection methods. Methods: The current research mainly evaluated and compared the analytical performances of two sST2 detection methods: magnetic particle chemiluminescence (CLIA) and enzyme-linked immunosorbent assay (ELISA), with reference to CLSI documents and industry standard requirements. A total of 229 serum samples were collected to evaluate the correlation between the two methods. Results: The study showed that the precision, linear range, minimum detection limit, quantitative detection limit, and reference interval evaluation results of the two methodologies met the requirements of the instructions. Among them, CLIA method's within-run precision (CV < 3%) and between run precision (CV < 3%) were significantly better than those of ELISA method (within-run precision CV < 5%, between run precision CV < 11%), (all P values < 0.05). CLIA method's linear range (1.00-300.00) ng/mL, minimum detection limit (0.12 ng/mL) and quantitative detection limit (1.00 ng/mL) were also better than ELISA method's linear range (3.00-200.00) ng/mL, minimum detection limit (0.36 ng/mL) and quantitative detection limit (2.40 ng/mL). The correlation coefficient of the two detection methods for a total of 229 clinical samples was R² = 0.9871, and there was no significant difference between CLIA method and control ELISA method (P > 0.05). Conclusion: CLIA detection method is superior to ELISA in precision, minimum detection limit, while CLIA has a wider linear range, which improves detection efficiency. Therefore, in summary, the performance of CLIA detection method is superior to ELISA method. (authors)