Method evaluation study of a new generation of vitamin D assays

Enko, Dietmar; Kriegshäuser, Gernot; Stolba, Robert; Worf, Elfriede; Halwachs‐Baumann, Gabriele

doi:10.11613/bm.2015.020

Cited by 60 publications

(54 citation statements)

References 29 publications

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“…The mass screening of the VD deficiency, which is based on the blood 25(OH)D 3 quantification, in neonatal infants is important for the early detection, diagnosis and health risk assessment of several diseases (Enko, Kriegshäuser, Stolba, Worf, & H‐Baumann, ; Gervasoni, Cocci, Zuppi, & Persichilli, ). A permanently charged Cookson‐type reagent called SecoSET™ (Figure h), which is commercially available from Novilytic as the VD assay kit, was applied to the determination of plasma 25(OH)D 3 on the card (dried blood spot).…”

Section: Application Of Cookson‐type Reagents To Analysis Of Vd Compomentioning

confidence: 99%

Application of Cookson‐type reagents for biomedical HPLC and LC/MS analyses: a brief overview

Higashi

Shimada

2016

Biomedical Chromatography

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High-performance liquid chromatography (HPLC), LC/mass spectrometry (MS) and LC/tandem mass spectrometry (MS/MS) have been widely used for biomedical analyses, in which chemical derivatization is one of the most important methods to increase the sensitivity and selectivity. A Cookson-type reagent [4-substituted-1,2,4-triazoline-3,5-dione (4-substituted-TAD)] reacts with the compound bearing a conjugated diene, such as the vitamin D compound, to quantitatively form the stable Diels-Alder adduct. The reagent with a chromophore or fluorophore at the 4-position of TAD yields a highly responsive adduct for the UV or fluorescence detection, respectively. The Diels-Alder adduct with a Cookson-type reagent having a permanently charged, proton-affinitive or electron-affinitive moiety is sensitively detected by a specific MS analyzer. This paper is a brief overview of the applications of the reagents for biomedical analyses mainly using HPLC or LC/MS(/MS).

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Section: Application Of Cookson‐type Reagents To Analysis Of Vd Compomentioning

confidence: 99%

Application of Cookson‐type reagents for biomedical HPLC and LC/MS analyses: a brief overview

Higashi

Shimada

2016

Biomedical Chromatography

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“…On the other hand Clinical and Laboratory Standards Institute (CLSI) recommends plotting differences against the reference method. Therefore, differences between values from comparative immunoassays and the reference method against the reference method value were displayed in the difference plots according to CLSI recommendations (Enko, 2015).…”

Section: Discussionmentioning

confidence: 99%

A Comparison between Three Different Automated Total 25-hydroxyvitamin D Immunoassay Methods and Ultra Performance Liquid Chromatography

Reda¹,

Soliman²,

Girguis³

et al. 2020

Asian Pac J Cancer Prev

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Objective: Vitamin D is a fat soluble vitamin responsible for calcium metabolism and more recently discovered effects. This led to an increase in requests for vitamin D test by clinicians. New automated assays have been introduced for 25-hydroxyvitamin D measurement. Methods: Results from these new method have to be related to a Standard method to obtain best results for practical usage. In our study, one hundred venous blood samples were analyzed for 25-OH vitamin D on three immunological methods in our lab and correlated with ultra-performance liquid chromatography (UPLC) method as a reference method. Results: Statistically analysis of results obtained for correlations between the 3 methods against the reference UPLC was done by Spearman's Correlation. It showed positive correlation in all methods with significant p value < 0.001. Differences and biases between methods were evaluated using a Bland-Altman plot and Cohen's Kappa agreement. Best agreement was found in Cobas 6000 followed by the Access2 then comes Architect. Conclusions: All immunoassays can be used in routine 25(OH) D measurements, still some methods are better than others. A clinical laboratory must at least be aware of its method to avoid misinterpretation of results.

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“…Because of the high percentage (51-62%) of cross-reactivity with 3-epi-25-hydroxyvitamin D, the enzymatic method seems to be unsuitable for measurements of vitamin D in paediatric samples [11]. A recent study by Stepman et al showed that 3-epi metabolites could be identified not only in children but also in adults, reaching up to [13,17]. Evaluation of mean bias was achieved by Bland-Altman calculations.…”

Section: Discussionmentioning

confidence: 99%

“…The cross-reactivity with 24,25(OH) 2 or 3-epimers in some immunoassays can contribute to overestimation of 25(OH)D and consequently lead to misclassification of vitamin D status. The percentage of 3-epi metabolite was estimated by Bailey et al to be 11% in pregnant women and up to 25% in infants [9,13]. The "gold standard" for adequate separation of 3-epimers and 24,25(OH)D metabolites, which is the function of LC-MS/MS, cannot be commonly implemented because of economical and organisational reasons.…”

Section: Introductionmentioning

confidence: 99%

Comparison of two different methods for routine 25(OH)D measurement in paediatric serum samples

Szternel¹,

Siódmiak²,

Bergmann³

et al. 2018

Medical Research Journal

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Over the last decade interest in automated assays for 25-hydroxy-vitamin D measurement have greatly increased. The presence of different metabolites of vitamin D in the blood influences measurement of its concentration. In paediatric subjects the basic interference is due to the presence of 3-epi-25(OH)D 2 /D 3 , which despite their biological inactivity, influences the total concentration of 25(OH)D. Aim: We assessed the analytical performance and usefulness of two different assays for measurement of total 25(OH)D in children. Materials and Methods: The study was performed in blood samples taken from 100 school-children aged 9-11 years. In all serum samples 25(OH)D total concentration was measured with the use of chemiluminescent assay, which is known to show no cross-reactivity with 3-epi-25(OH)D, and with the use of a newly developed enzyme-immunosorbent method. Results: The mean 25(OH)D concentration in children measured with enzyme-immunosorbent assay (EIA) was significantly higher, at 28.06 ng/mL, than with the chemiluminescent assay (CLIA), at 21.13 ng/mL; < 0.0001. In children with optimal weight the average 25(OH)D was 32.93 ng/ml (EIA) and 21.5 ng/mL (CLIA) (p < 0.0001), respectively, whereas in a subgroup with overweight/obesity the mean concentration of 25(OH)D was similar, at 23.2 ng/ml (EIA) and 20.76 ng/ml (CLIA) (p = 0.15). The nonparametric Spearman's rank correlation of two methods equalled 0.47; 95%CI (0.11 to 0.60) with a significance level p < 0.0001. The calculated concordance correlation coefficient between two methods in the whole group was 0.26; 95%CI (0.17 to 0.35). In a subgroup of children with optimal body mass (N = 50) the concordance correlation coefficient was 0.18; 95%CI (0.06 to 0.29), whereas in children with overweight/obesity (N = 50) it was 0.44; 95%CI (0.29 to 057). Mean bias for the enzyme-immunosorbent method equalled 18.7%; +/-1.96 SD (101.3% to-64%). Conclusions: With reference to 25(OH)D measurement in children, Spearman's correlation coefficient indicated "moderate correlation" between the two compared methods, whereas the strength of agreement (concordance) between both methods was characterised as "poor". The proper selection of assay for accurate assessment of vitamin D status in paediatric samples is necessary to avoid misdiagnosis.

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Method evaluation study of a new generation of vitamin D assays

Cited by 60 publications

References 29 publications

Application of Cookson‐type reagents for biomedical HPLC and LC/MS analyses: a brief overview

Application of Cookson‐type reagents for biomedical HPLC and LC/MS analyses: a brief overview

A Comparison between Three Different Automated Total 25-hydroxyvitamin D Immunoassay Methods and Ultra Performance Liquid Chromatography

Comparison of two different methods for routine 25(OH)D measurement in paediatric serum samples

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