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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

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Pathology & Laboratory Medicine Institute, Sheikh Khalifa Medical City, Abu Dhabi 51900, UAE
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Pathology & Laboratory Medicine Department, Military Hospital, Riyadh 11159, Kingdom of Saudi Arabia
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Pediatric Institute, Sheikh Khalifa Medical City, Abu Dhabi 51900, UAE
*
Author to whom correspondence should be addressed.
Nutrients 2013, 5(3), 971-980; https://doi.org/10.3390/nu5030971
Received: 22 November 2012 / Revised: 11 January 2013 / Accepted: 7 March 2013 / Published: 22 March 2013
(This article belongs to the Special Issue Vitamin D and Human Health)
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. View Full-Text
Keywords: 25-hydroxyvitamin D; method evaluation; electrochemiluminescence; high performance liquid chromatography 25-hydroxyvitamin D; method evaluation; electrochemiluminescence; high performance liquid chromatography
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Abdel-Wareth, L.; Haq, A.; Turner, A.; Khan, S.; Salem, A.; Mustafa, F.; Hussein, N.; Pallinalakam, F.; Grundy, L.; Patras, G.; Rajah, J. 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. Nutrients 2013, 5, 971-980.

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