Determination of biological variation of Carbohydrate-Deficient transferrin and other sialotransferrin forms via a commercial HPLC procedure using indirect sampling.

OBJECTIVE

The study aimed to determine the biological variation (BV) components for carbohydrate-deficient transferrin (CDT-disialotransferrin) and various forms of sialylated transferrin (sialoTf) via indirect sampling and establish analytical performance targets for clinical and diagnostic applications, particularly in monitoring alcohol consumption.

METHODS

Herein, serial sialoTf measurements via high-performance liquid chromatography (Eureka Lab Division, Sentinel Diagnostics, Italy) were collected from 141 subjects aged 18-65. The participants were grouped based on the follow-up duration (short-term: 6-9 series; long-term: ≥10 series). The BV components, including within-subject (CV) and between-subject (CV) variations, were calculated using a twofold nested ANOVA. Reference change values (RCVs), individuality index (II) values, and analytical performance specifications were also determined.

RESULTS

A total of 141 patients (female:male = 24:117) were included in the study. The mean age of the participants was 37.9 ± 10.22 years, and the average number of follow-up series (min-max) per participant was 7.35 (ranging from 5 to 35 series). The median (IQR) levels for di-, tri-, tetra-, and pentasialoTf were 1.18 % (0.96-1.52), 4.19 % (3.31-5.17), 81.01 % (79.93-82.00), and 13.38 % (12.18-14.59), respectively. The CV and CV (95 % CI), respectively, were as follows: disialoTf, 26.3 (24.3-28.5) and 11.4 (6.2-17.9); trisialoTf, 23.5 (21.9-25.4) and 13.3 (9.1-18.8); tetrasialoTf, 1.5 (1.4-1.6) and 0.6 (0.4-0.9); and pentasialoTf, 9.7 (9.1-10.3) and 6.2 (4.7-8.2). The RCV% for di-, tri-, tetra-, and pentasialoTf was calculated as 91.35, 72.5, 5.2, and 36.5 %, respectively, and the II values were 2.29, 1.77, 2.36, and 1.56, respectively.

CONCLUSION

In this study, the BV components for CDT and other sialoTf forms were determined. The indirect sampling approach is a reliable alternative for BV estimation, offering valuable insights for clinical decision-making and analytical performance targets in sialoTf measurements.