TY - JOUR
T1 - Analytical performance specifications for 25-hydroxyvitamin d examinations
AU - Cavalier, Etienne
AU - Fraser, Callum G.
AU - Bhattoa, Harjit P.
AU - Heijboer, Annemieke C.
AU - Makris, Konstantinos
AU - Ulmer, Candice Z.
AU - Vesper, Hubert W.
AU - Vasikaran, Samuel
AU - Lukas, Pierre
AU - Delanaye, Pierre
AU - Carobene, Anna
AU - IFCC-IOF Committee for Bone Metabolism
N1 - Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2021/1/28
Y1 - 2021/1/28
N2 - Currently the 25-hydroxy vitamin D (25(OH)D) concentration is thought to be the best estimate of the vitamin D status of an individual. Unfortunately, its measurement remains complex, despite recent technological advances. We evaluated the biological variation (BV) of 25(OH)D in order to set analytical performance specifications (APS) for measurement uncertainty (MU). Six European laboratories recruited 91 healthy participants. The 25(OH)D concentrations in K3-EDTA plasma were examined weekly for up to 10 weeks in duplicate on a Lumipulse G1200 (Fujirebio, Tokyo, Japan). The linear regression of the mean 25(OH)D concentrations at each blood collection showed that participants were not in a steady state. The dissection of the 10-sample collection into two subsets, namely collections 1–5 and 6–10, did not allow for correction of the lack of homogene-ity: estimates of the within-subject BV ranged from 5.8% to 7.1% and the between-subject BV ranged from 25.0% to 39.2%. Methods that would differentiate a difference induced by 25(OH)D supple-mentation at p < 0.05 should have MU < 13.6%, while at p < 0.01, the MU should be <9.6%. The development of APS using BV assumes a steady state of patients. The findings in this study suggest that patients are not in steady state. Therefore, APS that are based on MU appear to be more appro-priate.
AB - Currently the 25-hydroxy vitamin D (25(OH)D) concentration is thought to be the best estimate of the vitamin D status of an individual. Unfortunately, its measurement remains complex, despite recent technological advances. We evaluated the biological variation (BV) of 25(OH)D in order to set analytical performance specifications (APS) for measurement uncertainty (MU). Six European laboratories recruited 91 healthy participants. The 25(OH)D concentrations in K3-EDTA plasma were examined weekly for up to 10 weeks in duplicate on a Lumipulse G1200 (Fujirebio, Tokyo, Japan). The linear regression of the mean 25(OH)D concentrations at each blood collection showed that participants were not in a steady state. The dissection of the 10-sample collection into two subsets, namely collections 1–5 and 6–10, did not allow for correction of the lack of homogene-ity: estimates of the within-subject BV ranged from 5.8% to 7.1% and the between-subject BV ranged from 25.0% to 39.2%. Methods that would differentiate a difference induced by 25(OH)D supple-mentation at p < 0.05 should have MU < 13.6%, while at p < 0.01, the MU should be <9.6%. The development of APS using BV assumes a steady state of patients. The findings in this study suggest that patients are not in steady state. Therefore, APS that are based on MU appear to be more appro-priate.
KW - 25(OH)-vitamin D
KW - Analytical performance specifications biological variation
KW - Measurement uncertainty
KW - Vitamin D
UR - http://www.scopus.com/inward/record.url?scp=85100108778&partnerID=8YFLogxK
U2 - 10.3390/nu13020431
DO - 10.3390/nu13020431
M3 - Article
C2 - 33525653
AN - SCOPUS:85100108778
SN - 2072-6643
VL - 13
JO - Nutrients
JF - Nutrients
IS - 2
M1 - 431
ER -