Biological variation of plasma 25-Hydroxyvitamin D3, Serum vitamin B12, folate and ferritin in Turkish healthy subject.

Abstract

Biological variation (BV) plays a crucial role in determining analytical performance specifications, assessing serial measurements of individuals, and establishing the use of population-based reference intervals. Our study aimed to calculate the BV and BV-based quality goals of 25-hydroxyvitamin D₃ (25-OH D₃), ferritin, folate and vitamin B12 tests. We included a total of 22 apparently healthy volunteers (9 women and 13 men) aged 18-55 years in the study that we conducted in Turkey. Blood samples were collected from the participants once a week for five weeks. Serum ferritin, folate and vitamin B12 levels were measured using immunochemical method, while plasma 25-OH D₃ levels were determined using the high-performance liquid chromatography method. Analysis of variance (ANOVA) was used to estimate analytical variation(CV_A), within-subject BV(CV_I) and between-subject BV(CV_G). The individuality index (II) and reference change value (RCV) were calculated based on these data. The CV_I of 25-OH D₃, ferritin, folate, and vitamin B12 were found to be 1.8% (0.6%-2.5%), 16.9% (14.4%-20.2%), 10.7% (9.2%-12.7%), and 8.6% (6.8%-10.5%), respectively. CV_G were 44.2% (34.3%-69.9%), 132% (87.7%-238%), 19.4% (14.4%-28.8%), and 39.6% (29.8%-59.0%) for the same biomarkers, while CV_A were 3.2% (2.81%-3.71%), 3.5% (3.1%-4.1%), 4.0% (3.5%-4.6%), and 7.5% (6.6%-8.6%), respectively. The II values for 25-OH D₃, ferritin, folate, and vitamin B12 were calculated as 0.04, 0.13, 0.55, and 0.22, respectively. The RCV were 10.2%, 47.8%, 31.7%, and 31.6%, respectively. Because the tests analyzed in this study exhibit high individuality, RCV should be preferred rather than population-based reference ranges in clinical interpretation of results.