Accuracy of 6 Routine 25-Hydroxyvitamin D Assays: Influence of Vitamin D Binding Protein Concentration

Heijboer, Annemieke C.; Blankenstein, Marinus A.; Kema, Ido P.; Buijs, Madelon M.

doi:10.1373/clinchem.2011.176545

Cited by 306 publications

(230 citation statements)

References 21 publications

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“…This also ensures that the endogenous binding protein does not interfere with the assay. A study investigating the influence of VDBP on the performance of 25-OHD immunoassays confirmed that the Elecsys assay is not affected by special cohorts having elevated VDBP concentrations such as pregnant women (29).…”

Section: Discussionmentioning

confidence: 88%

Automated Competitive Protein‐Binding Assay for Total 25‐OH Vitamin D, Multicenter Evaluation and Practical Performance

Wielders

Carter²,

Eberl

et al. 2014

Clinical Laboratory Analysis

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Background:The Roche Elecsys Vitamin D Total competitive protein-binding assay uses recombinant vitamin D binding protein for measuring 25-hydroxyvitamin D (25-OHD), which is different from commonly used antibody assays. Methods: The assay, standardized against LC-MS/MS, was tested at four sites. Evaluation included precision; between-laboratory variability; functional sensitivity; correlation to LC-MS/MS, HPLC, and immunoassays; as well as robustness, traceability, and EQAS performance. Results: Precision testing showed within-run coefficient of variations (CVs) of ࣘ7%, within-laboratory CVs of <9.5%, between-laboratory precision CVs of ࣘ10.1%, and a functional sensitivity below 9.8 nmol/l (at CV 12.9%). The assay showed equivalent 25-OHD levels for matched serum and plasma samples, good reagent lot-to-lot consistency in pooled sera over time, and good agreement with HPLC (relative bias −8.8%). Comparison with LC-MS/MS methods yielded relative biases of −15.4, −13.5, −10.2, and 3.2%. Comparison against immunoassays showed a relative bias of 14.5% (DiaSorin Liaison) and −58.2% (IDS-iSYS). The overall mean results in 2 years DE-QAS was 102% of the ALTM. In a certified reference patient panel, the average bias was <4% for the sum of 25-OHD2 and 25-OHD3. Conclusion: The Elecsys Vitamin D Total assay demonstrated good overall performance and is, according to present standards, very suitable for automated measurement of 25-OHD.

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Section: Discussionmentioning

confidence: 88%

Automated Competitive Protein‐Binding Assay for Total 25‐OH Vitamin D, Multicenter Evaluation and Practical Performance

Wielders

Carter²,

Eberl

et al. 2014

Clinical Laboratory Analysis

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“…21 Another limiting factor is that the immunoassay used for detecting 25-hydroxyvitamin D in the study depends on vitamin D binding protein, which is decreased in septic states. 47 Furthermore, a small study 48 of cardiovascular surgery patients indicated that intravenous fluid replacement results in hemodilution, which lowers serum concentration of 25-hydroxyvitamin D by 35% for up to 24 hours. However, in our study, only 9 patients (7%) had 25-hydroxyvitamin D levels measured within 24 hours of the start of sepsis, thus limiting subtherapeutic 25-hydroxyvitamin D concentrations due to decreased vitamin D binding protein and fluid shifts.…”

Section: Financial Disclosures None Reportedmentioning

confidence: 99%

Deficiency in 25-Hydroxyvitamin D and 30-Day Mortality in Patients With Severe Sepsis and Septic Shock

Rech

Hunsaker

Rodriguez

2014

American Journal of Critical Care

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Background Vitamin D has immunomodulating properties. Objective To determine if vitamin D deficiency within 30 days of admission to the intensive care unit in patients with sepsis might be associated with increased all-cause 30-day mortality. Methods In a retrospective cohort study at a large, tertiary, urban, academic medical center, records of patients who had 25-hydroxyvitamin D levels measured within 30 days of admission for severe sepsis or septic shock from June 2006 to April 2011 were examined. Patients were considered deficient in vitamin D if its serum concentration was 15 ng/mL or less. The primary outcome of interest was 30-day mortality. Results Among the 121 patients in the sample, 65 (54%) were vitamin D deficient. Baseline demographics were similar between vitamin D deficient and nondeficient groups, except that the vitamin D deficient group had more African Americans (P = .01). All-cause 30-day mortality was significantly higher in patients deficient in vitamin D (37% vs 20%; P = .04) and remained higher at 90 days (51% vs 25%, P = .005). In multivariate analysis, age (odds ratio, 1.04; 95% CI 1.01–1.07; P = .01) and vitamin D deficiency (odds ratio, 2.7; 95% CI, 1.39–18.8; P = .02) were independently associated with increased 30-day mortality. Conclusion Patients deficient in vitamin D within 30 days of hospital admission for severe sepsis or septic shock may be at increased risk for all-cause 30-day mortality.

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“…This study adds to a growing literature [9][10][11][12][13][14][15][16][17][22][23][24][25][26][27][28] [13,15,23]. In the accuracy performance testing using Labquality reference serum panel, both Roche and Abbott displayed a similar bias at higher 25(OH)D concentrations as with study serum samples.…”

Section: Discussionmentioning

confidence: 65%

“…It is a small hydrophobic molecule, and therefore subject to matrix effects resulting from interference by lipids: this problem is not encountered with chromatographic or competitive protein binding assays. In addition, it is tightly bound to vitamin D binding protein (VDBP), which can compete with capturing antibodies used in immunoassays, or with other competitive binding proteins; inaccuracy in some of Abbott's Architect assay, has been shown to be largely dependent on VDBP concentrations [16,17,22].…”

Section: Discussionmentioning

confidence: 99%

Analytical and clinical performance of the new Fujirebio 25-OH vitamin D assay, a comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and three other automated assays

Saleh

Müller

Eckardstein

2016

Clinical Chemistry and Laboratory Medicine (CCLM)

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Results: Intra-and inter-day imprecision of the Fujirebio 25(OH)D assay was < 5%. Fujirebio 25(OH)D assay showed the highest correlation among the assays tested with the LC-MS/MS method (R = 0.986). The mean relative bias obtained was -15.6% (Fujirebio), -12.7% (Beckman), -2.1% (Abbott) and 9.7% (Roche) as compared to LC-MS/ MS. Comparison with the Labquality certified reference serum panel yielded a mean bias of -11.8% (Fujirebio), -14.1% (Beckman), 4.4% (Abbott) and 3.2% (Roche), respectively. Compared to LC-MS/MS, the sensitivity of different methods in detecting vitamin D insufficiency ( < 50 nmol/L) varied from 100% for the Fujirebio assay to 72.7% for Roche, and specificity ranged from 94.4% for Roche to 87.6% for Beckman.

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Accuracy of 6 Routine 25-Hydroxyvitamin D Assays: Influence of Vitamin D Binding Protein Concentration

Cited by 306 publications

References 21 publications

Automated Competitive Protein‐Binding Assay for Total 25‐OH Vitamin D, Multicenter Evaluation and Practical Performance

Automated Competitive Protein‐Binding Assay for Total 25‐OH Vitamin D, Multicenter Evaluation and Practical Performance

Deficiency in 25-Hydroxyvitamin D and 30-Day Mortality in Patients With Severe Sepsis and Septic Shock

Analytical and clinical performance of the new Fujirebio 25-OH vitamin D assay, a comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and three other automated assays

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