Performance Validation and Clinical Concordance of a Novel Fully Automated Immunoassay System for Five Tumor Markers: A Comparative Study with an International Reference Platform

The high cost of imported platforms limits widespread lung cancer risk stratification in resource-limited settings. Based on CLSI guidelines, this study aimed to conduct a preliminary analytical verification of a novel automated chemiluminescence immunoassay system (Health) for five tumor markers (SCC, CEA, CYFRA21-1, Pro-GRP, and NSE), and to compare it with established reference systems. Analytical precision and method comparison with Roche, Abbott, and Beckman platforms were verified referencing CLSI EP recommendations. A total of 180 patients with lung cancer and 77 healthy controls were enrolled. Receiver operating characteristic (ROC) curve analysis was performed to evaluate the diagnostic performance of individual tumor markers and their combined use. The evaluated system demonstrated good precision across all analytes, with within-run and total coefficients of variation below 6.8%. Deming regression demonstrated high quantitative ( r > 0.98) and high qualitative agreement (Kappa > 0.93) with the reference platforms. The combined multi-marker panel partially compensated for the low sensitivity of individual markers (e.g., SCC, 4.0%), improving overall diagnostic performance to a moderate level (AUC = 0.731). Statistical comparison indicated that the combined AUC of the evaluated system was lower than that of the Roche platform (0.895, P < 0.001) but comparable to the Abbott system (0.782, P > 0.05), while maintaining relatively high specificity (>90%). Following preliminary verification, the system showed acceptable analytical performance and satisfactory reference concordance. While offering a cost-effective adjunctive tool for preliminary risk assessment, its clinical use requires external validation.