CK18-M30 serum stability for DILI assessment depends on storage temperature and tube type

Reliable assessment of drug-induced liver injury (DILI) is critical in clinical trials and pharmacovigilance. Cytokeratin 18-M30 (CK18-M30) is an emerging and widely used biomarker for liver apoptosis, indicating liver damage. However, the stability of this biomarker in serum under various storage conditions for deferred testing has not been thoroughly established. Ensuring sample integrity is paramount for accurate and trustworthy biomarker-based safety evaluations, especially when immediate analysis of clinical specimens is not feasible and samples need to be stored.

Researchers collected 22 human serum samples from individuals undergoing routine physical examinations, ensuring a range of CK18-M30 concentrations. An immediate test established the baseline CK18-M30 value for each sample. The remaining samples were then divided into five groups and stored under different conditions: -20°C in cryotubes for 3 days, and 2-8°C in both cryotubes and separation gel tubes for 3 days or 7 days. The primary endpoint was the concordance rate of CK18-M30 levels with the baseline values after storage, aiming to provide data-driven evidence for sample stability.