Abstract Background Patients with type 2 diabetes (T2D) are at high risk of metabolic dysfunction-associated steatotic liver disease, which may progress to advanced fibrosis but remains underdiagnosed in routine clinical practice. Automated laboratory-based tools may improve early identification of at-risk patients. Methods We conducted a retrospective single-center study between January 2023 and August 2025 including 445 patients with T2D. The Fibrosis-4 (FIB-4) score was automatically calculated through the laboratory information system. Its diagnostic performance was assessed in patients who underwent transient elastography (TE). Results The median age was 58 years, 64% of patients were obese, and 55% were men. Men had a higher risk of elevated FIB-4 (odds ratio = 1.32, P < 0.05). FIB-4 was ≥1.3 in 36.9% of patients. Among the 43 patients referred for TE, 26 (60.5%) had significant fibrosis. FIB-4 correlated with liver stiffness (r = 0.48; P < 0.01), with an area under the ROC curve of 0.74 (95% CI, 0.58–0.89) for detecting significant fibrosis (≥8 kPa) using a cutoff of 1.33 (sensitivity 84.6%; specificity 47.1%). Patients with significant fibrosis had significantly higher alkaline phosphatase (P = 0.03) and C-reactive protein levels (P = 0.01). Only 14% of at-risk patients underwent TE. Conclusions Automated calculation of FIB-4 enables identification of patients with T2D at risk of liver fibrosis in routine practice. However, its clinical impact may be limited by low referral rates for confirmatory testing. The diagnostic performance estimates reported here derive from a selected TE subcohort and should therefore be interpreted with caution. Integration of such laboratory-based tools into clinical workflows may support earlier detection, provided that appropriate care pathways are implemented.
Abstract Background Vitamin B12 is an essential water-soluble vitamin required for critical biological processes such as DNA synthesis, erythrocyte maturation, and maintenance of nervous system integrity. Deficiency of vitamin B12 can lead to serious clinical outcomes, including megaloblastic anemia and potentially irreversible neurological damage. Conversely, hypercobalaminemia may be associated with severe disorders, including solid neoplasms and hematological malignancies, or may result from inappropriate supplementation or immunoglobulin–B12 macrocomplexes. Current guidelines recommend total serum vitamin B12 and holotranscobalamin (holoTC) as first-line biomarkers for assessing cobalamin status. Content Despite guideline recommendations, total serum vitamin B12 remains the most widely used test in routine clinical practice. However, holoTC represents the biologically active fraction of vitamin B12 available for receptor-mediated cellular uptake and may therefore provide a more reliable assessment of cobalamin status, particularly in specific clinical settings. Compared with total vitamin B12 measurement, holoTC is evaluated using a more limited number of analytical methods, and most commercially available assays are traceable to the WHO reference standard, improving interassay harmonization. This review examines the role of vitamin B12 and holoTC, focusing on analytical challenges and clinical interpretation. Summary The available evidence suggests that holoTC may offer important advantages over total serum vitamin B12 in the evaluation of B12 status. Its biological relevance and improved analytical harmonization support its potential utility as a more reliable biomarker in selected clinical contexts.
