title: Total vitamin D assay comparison of the Roche Diagnostics "Vitamin D total" electrochemiluminescence protein binding assay with the Chromsystems HPLC method in a population with both D2 and D3 forms of vitamin D.
abstract: This study compared two methods of assaying the 25-hydroxylated metabolites of cholecalciferol (vitamin D3) and ergocalciferol (vitamin D2). A fully automated electrochemiluminescence assay from Roche Diagnostics and an HPLC based method from Chromsystems were used to measure vitamin D levels in surplus sera from 96 individuals, where the majority has the D2 form of the vitamin. Deming regression, concordance rate, correlation and Altman Bland agreement were performed. Seventy two subjects (75%) had a D2 concentration >10 nmol/L while the remaining twenty four subjects had vitamin D2 concentration of less than 10 nmol/L by HPLC. Overall, the Roche Diagnostics method showed a negative bias of -2.59 ± 4.11 nmol/L on the e602 as compared to the HPLC with a concordance rate of 84%. The concordance rate was 91% in samples with D2 of less than 10 nmol/L and 82% in those with D2 concentration >10 nmol/L. The overall correlation had an r value of 0.77. The r value was higher in samples with D2 levels of less than 10 nmol/L, r = 0.96, as compared to those with D2 values of greater than 10 nmol/L, r = 0.74. The observed bias had little impact on clinical decision and therefore is clinically acceptable.
authors.affiliation: Pathology & Laboratory Medicine Institute, Sheikh Khalifa Medical City, Abu Dhabi 51900, UAE. labdelwareth@skmc.ae
authors.forename: Laila
authors.initials: L
authors.lastname: Abdel-Wareth
authors.forename: Afrozul
authors.initials: A
authors.lastname: Haq
authors.forename: Andrew
authors.initials: A
authors.lastname: Turner
authors.forename: Shoukat
authors.initials: S
authors.lastname: Khan
authors.forename: Arwa
authors.initials: A
authors.lastname: Salem
authors.forename: Faten
authors.initials: F
authors.lastname: Mustafa
authors.forename: Nafiz
authors.initials: N
authors.lastname: Hussein
authors.forename: Fasila
authors.initials: F
authors.lastname: Pallinalakam
authors.forename: Louisa
authors.initials: L
authors.lastname: Grundy
authors.forename: Gemma
authors.initials: G
authors.lastname: Patras
authors.forename: Jaishen
authors.initials: J
authors.lastname: Rajah
mesh_terms: D002762:Cholecalciferol / Q000097:blood* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D055664:Electrochemical Techniques / Q000379:methods*; D004872:Ergocalciferols / Q000097:blood* / Q000737:chemistry; D006801:Humans; D016014:Linear Models; D008163:Luminescent Measurements / Q000379:methods*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D004872:Ergocalciferols; D002762:Cholecalciferol