Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodialyzed and intensive care patients

Abstract

Fujirebio Lumipulse®G 25-OH Vitamin D Total assay is therefore considered suitable for assessment of vitamin D status in clinical routine.

Analytical and clinical validation of the new Abbot Architect 25(OH)D assay: fit for purpose?

“…Compared to competing immunoassays, the new 5P02 assay presents a better agreement with the LC-MS/MS, in the global population, but also especially in osteoporotic patients and in patients from the intensive care unit. Unfortunately, we did not have the opportunity to compare the performances of the 5P02 assay to the Fujirebio Lumipulse we recently validated and which is the only sandwich method available for 25(OH)D. Indeed, our results had shown that this assay presented a much improved clinical concordance compared to the other "classical" competitive immunoassays [11].…”

Consensus statement from 2nd International Conference on Controversies in Vitamin D

“…If we consider 30 nmol/L as the threshold for hypovitaminosis D, the question is whether we can apply this threshold using every current method (mostly automated immunoassays)? Comparisons among and between methods show a bias of several immunoassays compared to LC-MS/ MS methodologies [31][32][33][34].…”

An evaluation of total 25-hydroxyvitamin D assay standardization: Where are we today?

“…Several studies have evaluated and compared 25(OH)D assays. Though the methods overall correlated well, substantial variability between assays was found [12][13][14][15][16]. Some of these studies were performed early after the initiation of the VDSP initiative where standardization of assays…”