title: 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: BACKGROUND
  In this study, we provide a short analytical evaluation of the new Fujirebio Lumipulse®G non-competitive immunoassay for 25(OH)D. Clinical performance was compared with three commercial competitive automated immunoassays against a Vitamin D Standardization Program (VDSP)-traceable liquid chromatography-tandem mass spectrometry (LC-MS/MS) in six different clinically relevant populations.
  
  
  METHODS
  Lumipulse®G 25(OH)D precision, measurement uncertainty, recovery, limit of quantification were assessed, as well as 25(OH)D2 and C3-epimer recovery. For method comparison, 250 serum samples obtained in healthy Caucasians and Africans, osteoporotic, hemodialyzed and intensive care patients and 3rd trimester pregnant women were analyzed by all methods. Correlation was studied using Passing-Bablok and Bland-Altman analysis. Concordance correlation coefficient (CCC) was calculated to evaluate agreement between immunoassays and the LC-MS/MS.
  
  
  RESULTS
  The Lumipulse®G 25(OH)D assay presented interesting analytical features and showed excellent correlation to the LC-MS/MS results (y=1.00×-1.35 ng/mL), as obtained in healthy Caucasian individuals. In the other special populations, Lumipulse®G presented a concordance with LC-MS/MS which was generally higher than competitors, even if all methods significantly under-recovered 25(OH)D in hemodialyzed patients. Intra-assay CV ranged from 12.1% at 9.6 ng/mL to 2.1% at 103.7 ng/mL and inter-assay CV ranged from 16.2 to 3.7% at the same concentrations, respectively. Measurement uncertainty, with a probability of 95%, were respectively 33.1 and 7.6% at these concentrations. LOQ was found to be at 4.6 ng/mL. Mean (95% CI) 25(OH)D2 revovery was 77% (74-81) and no cross-reactivity was observed with C3-epimer.
  
  
  CONCLUSIONS
  Fujirebio Lumipulse®G 25-OH Vitamin D Total assay is therefore considered suitable for assessment of vitamin D status in clinical routine.
authors.forename: Etienne
authors.initials: E
authors.lastname: Cavalier
authors.forename: Pierre
authors.initials: P
authors.lastname: Lukas
authors.forename: Anne-Catherine
authors.initials: AC
authors.lastname: Bekaert
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Peeters
authors.forename: Caroline
authors.initials: C
authors.lastname: Le Goff
authors.forename: Eric
authors.initials: E
authors.lastname: Yayo
authors.forename: Pierre
authors.initials: P
authors.lastname: Delanaye
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Souberbielle
mesh_terms: D044383:Black People; D002853:Chromatography, Liquid; D003422:Critical Care; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007118:Immunoassay; D010024:Osteoporosis / Q000097:blood*; D011247:Pregnancy; D011263:Pregnancy Trimester, Third / Q000097:blood*; D006435:Renal Dialysis; D053719:Tandem Mass Spectrometry; D014807:Vitamin D / Q000031:analogs & derivatives* / Q000097:blood; D044465:White People
chemical_list: D014807:Vitamin D; C104450:25-hydroxyvitamin D