The new Roche Vitamin D Total assay: fit for its purpose?

Emmen, Judith M. A.; Wielders, Jos P.M.; Boer, Arjen‐Kars; Ouweland, Johannes M.W. van den; Vader, Huib L.

doi:10.1515/cclm-2011-0085

Cited by 38 publications

(21 citation statements)

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“…Other recent publications based on the Elecsys assay have confirmed that the assay has good precision and accuracy, and shows close agreement to other wellestablished methods for 25-OHD analysis, making it very suitable for routine assessment of vitamin D status (32,36,39,40). In conclusion, the Elecsys assay demonstrated low imprecision, high sensitivity, good lot-to-lot consistency, as well as good overall agreement with measurements obtained using LC-MS/MS and HPLC methods.…”

Section: Discussionsupporting

confidence: 69%

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: Discussionsupporting

confidence: 69%

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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“…These findings obtained for the whole group showed variable concordance with other studies and were compatible with recent studies on the performance of the Architect and Cobas systems. 35,36 These regression analysis results were also comparable with the results reported by Ong et al In another comparison study conducted by Farrel et al, both the Architect and the Cobas systems exhibited dissimilar results. 37,38 Heijboer et al evaluated the influence of DBP on the accuracy of the assays and found better results for the Cobas system and worse results for the Architect system using healthy individuals.…”

Section: Discussionsupporting

confidence: 87%

Evaluation of Vitamin D Assays in Relation to the Measurement Range and the Statistical Method

Yücel¹,

Kara²,

Madenci³

et al. 2014

Turkiye Klinikleri J Med Sci

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A AB BS S T TR RA AC CT T O Ob bj je ec ct ti iv ve e: : The aim of this study was to compare three vitamin D measuring assays with a reference method to analyze whether their performance varied according to different statistical procedures and measurement ranges used. M Ma at te er ri ia al l a an nd d M Me et th ho od ds s: : Three vitamin D measurement methods, a high-performance liquid chromatography (HPLC) and two immunoassay systems (Architect, Abbott Diagnostics and Cobas, Roche Diagnostics) were compared with liquid chromatography tandem mass spectrometry (LCMS/MS) as the reference method in a study population of 141 individuals. The study group was investigated as whole group and two different subgroups of <50 ng/ml and <20 ng/ml, according to LCMS/MS measurements. The results were analyzed by Passing Bablok regression analysis, concordance correlation coefficient, interrater agreement, Bland Altman plots. R Re es su ul lt ts s: : Data generated from the various statistical analyses revealed that all of the methods investigated in this study performed worse for lower concentrations (<50 ng/ml and <20 ng/ml). The best overall performance was obtained by HPLC method. The methods showed variable performance with the statistical analysis used. C Co on nc cl lu us si io on n: : Method comparison studies of vitamin D are prone to variable results according to the statistical method and measurement range chosen. Method comparison studies should be based on clinical requirements. Laboratory professionals should determine the range that is important from clinical point of view, and should evaluate the results according to total allowable error for that range.K Ke ey y W Wo or rd ds s: : Vitamin D; immunoassay; chromatography, high pressure liquid; mass spectrometry Ö ÖZ ZE ET T A Am ma aç ç: : Çalışmanın amacı üç D vitamini ölçüm yöntemini, referans kabul edilen bir yöntemle karşılaştırmak ve performanslarının kullanılan istatistiksel yöntem ve seçilen ölçüm aralığına göre değişim gösterip göstermediğini değerlendirmektir. G Ge er re eç ç v ve e Y Yö ön nt te em ml le er r: : Yüz kırk bir bireyden oluşan bir çalışma grubunda, bir yüksek performans likid kromatografi (HPLC) ve iki immunoassay yöntemi (Architect, Abbott Diagnostics ve Cobas, Roche Diagnostics) referans yöntem olarak alınan bir sıvı kromatografi-ardşık kuẗle spektrometresi (LCMS/MS) yöntemi ile karşılaştırıldı. Sonuçlar tüm çalışma grubu, D vitamini konsantrasyonu <50 ng/ml olan ve <20 ng/ml olan üç ayrı alt grupta incelendi. Elde edilen veriler Passing Bablok regresyon analizi, konkordans uyum katsayısı, interrater uyum, Bland Altman grafikleri ile değerlendirildi. B Bu ul lg gu ul la ar r: : Farklı istatistiksel analizlerin sonucuna göre, tüm yöntemler daha düşük konsantrasyonlarda (<50 ng/ml ve <20 ng/ml) daha düşük performans gösterdi. Ayrıca yöntemler, kullanılan istatistiksel analize bağlı olarak değişen performanslar sergilediler. En iyi toplam performans HPLC yöntemi ile elde edildi. S So on nu uç ç: : Yöntem karşılaştırma çalışmalarında el...

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“…Vitamin D deficiency was defined as ⩽20 ng/ml while vitamin D insufficiency is recognized as 21-29 ng/ml. The recommended level for vitamin D is ⩾30 ng/ml [Emmen et al 2012].…”

Section: Methodsmentioning

confidence: 99%

Vitamin D as a risk factor for premature atherosclerosis in patients with type 2 diabetes

Al-Said

EL-Ghaffar

Salam

et al. 2015

Therapeutic Advances in Endocrinology

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Background: Several cardiovascular risk factors have been recognized in patients with diabetes and vitamin D deficiency is emerging as a new risk. The aim of this study was to determine the effect of vitamin D deficiency on the incidence of premature atherosclerosis in patients with type 2 diabetes. Methods: A total of 78 patients with type 2 diabetes were subjected to history taking, physical examination, fasting glucose level, homeostasis model assessment of insulin resistance, lipid profile, 25(OH) vitamin D measurement, and carotid Doppler. Results: Patients with normal carotid intima-media thickness (CIMT) had sufficient vitamin D. Of those with increased CIMT 23.1% had insufficient vitamin D while 76.9% had sufficient vitamin D (six patients had plaques, one of them had vitamin D insufficiency, and the other five patients had sufficient vitamin D). There was a statistically significant difference in the serum level of vitamin D between patients with increased CIMT, and those with normal intima, with a decreased level in the first group. There was a significant negative correlation between vitamin D and fasting blood glucose. There was a statistically significant correlation in left CIMT between the vitamin D sufficiency group and the vitamin D insufficiency group, with higher values in the second group. There was no statistically significant difference in serum cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in patients with increased CIMT and those with normal intima. Conclusions: Decreased vitamin D levels in patients with diabetes lead to increased CIMT. The absence of a statistically significance difference in lipid profile between increased and normal CIMT groups raises the possibility of underlying causes for atherosclerosis in patients with diabetes other than dyslipidemia.

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The new Roche Vitamin D Total assay: fit for its purpose?

Abstract: The new Elecsys assay fulfilled present analytical performance requirements and showed close agreement to other well-established methods for 25(OH)D analysis, making it fit for routine assessment of vitamin D status.

Cited by 38 publications

References 0 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

Evaluation of Vitamin D Assays in Relation to the Measurement Range and the Statistical Method

Vitamin D as a risk factor for premature atherosclerosis in patients with type 2 diabetes

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