Analytical and clinical validation of the new Abbot Architect 25(OH)D assay: fit for purpose?

Cavalier, Étienne; Lukas, Pierre; Bekaert, Anne-Catherine; Carlisi, Agnès; Goff, Caroline Le; Delanaye, Pierre; Souberbielle, Jean‐Claude

doi:10.1515/cclm-2016-0566

Cited by 21 publications

(16 citation statements)

References 8 publications

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“…Blood samples were drawn after at least a 4-h fast and stored at − 80 °C. Serum 25-hydroxyvitamin D, which is the circulating biomarker of vitamin D status, was analyzed between 2016 and 2018 at the University Medical Center Hamburg-Eppendorf (Hamburg, Germany) within the frame of the European BiomarCaRE project (Biomarkers for Cardiovascular Risk Assessment in Europe) [19] and measured using a one-step immunoassay on the Abbott Architect i2000 (Abbott Laboratories, Abbott Park, IL, USA) [20]. The valid measurement range was 8-160 ng/mL.…”

Section: Assessment Of Vitamin D Concentrationsmentioning

confidence: 99%

Time trends of vitamin D concentrations in northern Sweden between 1986 and 2014: a population-based cross-sectional study

et al. 2019

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Purpose Vitamin D, produced through cutaneous photosynthesis or ingested via foods or supplements, has generated considerable research interest due to its potential health effects. However, epidemiological data on the time trends of vitamin D status are sparse, especially from northern Europe. We examined the time trend of vitamin D concentrations in northern Sweden between 1986 and 2014. Methods We used data on 11,129 men and women (aged 25-74 years) from seven population-based surveys (the Northern Sweden MONICA study), recruited between 1986 and 2014. Serum vitamin D (25-hydroxyvitamin D) status was measured using a one-step immunoassay (Abbott Architect). Multivariable linear regression models, adjusted for age, sex, and a number of other variables, were used to estimate the time trend of vitamin D concentrations. Results The mean value of vitamin D in the entire study population was 19.9 ng/mL [standard deviation (SD) 7.9], with lower values in men (19.4 ng/mL; SD 7.5) than in women (20.5 ng/mL; SD 8.2). Using the survey in 1986 as reference category, the multivariable-adjusted mean difference [95% confidence interval (CI)] in ng/mL was 2.

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Section: Assessment Of Vitamin D Concentrationsmentioning

confidence: 99%

Time trends of vitamin D concentrations in northern Sweden between 1986 and 2014: a population-based cross-sectional study

et al. 2019

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“…As the sources of lead exposure have decreased (leaded gasoline and paint), so too has the number of children presenting with increased blood lead concentrations. The most recent CDC guidelines state that blood lead concentrations ≥5 μg/dL are considered increased, and in 2015 only 3% of US children <72 months of age had lead concentrations ≥5 μg/dL (3).…”

Section: To the Editormentioning

confidence: 99%

“…As the ease of quantifying blood lead has increased and median concentrations have decreased, the use of ZPP as a screen for lead toxicity has become unnecessary according to the most recent CDC guidelines (3). Despite these recommendations, we continued to receive requests for ZPP and lead…”

Section: To the Editormentioning

confidence: 99%

An Underestimation of 25-OH Vitamin D in Patients with Renal Disease by the Abbott Architect Immunoassay

Brock

Strickland

Bazydlo

et al. 2017

The Journal of Applied Laboratory Medicine

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“…Various analytical evaluations related to CV and bias have been published in previous studies in the literature [12][13][14]. Cavalier et al [16] reported within-run and between-run CV values of 10.9-13.3% and 1. .0-3.5%, respectively, and within-run, between-run, and between-day CV% values of the Beckman Coulter Access 25(OH)D Total test at concentrations of 21.5±6.5 ng/mL and 45.0±10 ng/mL in the Access2 System were 6.7-6.1% and 13.9-5.6%, respectively.…”

Section: Resultsmentioning

confidence: 99%

Evaluation of the analytical performance of two vitamin D immunoassay methods

Yis¹

2019

Int J Med Biochem

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Evaluation of the analytical performance of two vitamin D immunoassay methods V itamin D is a regulatory, bone-stimulating vitamin that has a role in the absorption of calcium and inorganic phosphorus from the intestine. A deficiency is known to be a risk factor for osteoporosis [1]. The importance of vitamin D deficiency in many chronic diseases, including cancer, diabetes, hypertension, and asthma, as well as bone, liver, and kidney diseases has also been demonstrated in recent studies [2, 3]. This has increased the demand for a 25-hydroxyvitamin D [25(OH)D] test as a routine measurement in clinical laboratories [4]. Among the analytical techniques used in vitamin D measurement are a radioimmune assay, enzyme-linked immunosorbent assay, chemiluminescence immunoassay, and chemiluminescence microparticle immunoassay methods, including a competitive immunoassay, competitive protein-binding measurement, non-immunological high performance liquid chromatography performed directly after chromatographic separation, and liquid chromatography using tandem-mass spectrometry (LC-MS/MS) [5]. The poor antibody selectivity of immunoassay methods results in significant differences in various 25(OH)D measurements through cross-reaction with other vitamin D metabolites, as well as serum matrix components, such as lipids [6, 7]. In recent years there has been discussion of reference methods and reference standards to improve the quality of 25(OH) D testing [3]. Standardization of the 25(OH)D test is a global problem [8]. The Architect 5P02 25(OH)D test (Abbott Labo-Objectives: The increasing clinical significance of 25-hydroxyvitamin D [25(OH)D] has made it an indispensable test in the laboratory. The aim of this study was to investigate the analytical performance of 2 widely used immunoassay methods, the new Abbott Architect 5P02 25-OH Vitamin D assay (Abbott Laboratories, Lake Bluff, IL, USA) and the Beckman Coulter product, the Access 25 (OH) Vitamin D Total assay (Beckman Coulter, Inc., Brea, CA, USA). Methods: A total of 96 serum samples were used to compare the accuracy, linearity, limit of blank, limit of detection, limit of quantification, and precision of the 2 tests using the Architect i2000SR System (Abbott Laboratories, Lake Bluff, IL, USA) and the Access2 (Beckman Coulter, Brea, CA, USA) immunoassay platform. Deming regression analysis and Bland Altman graphs were used to compare the 2 methods. Results: The within-run coefficient of variation (CV%) of the Architect and the Access systems was <3.1% and <6.72%, respectively. There was good linearity of the 25(OH)D measurement at 98.9-114% for the Architect assay and 94.1-103.5% for the Access assay at concentrations of 5-160 ng/mL and 6.2-210.4 ng/mL, respectively. The correlation coefficient was 0.921 (y=-2.1+0.97x). Conclusion: Thorough testing indicated that the new 5P02 Abbott Architect 25(OH)D and the Beckman Coulter Ac-cess2 25(OH)D Total test demonstrated appropriate analytical performance.

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Analytical and clinical validation of the new Abbot Architect 25(OH)D assay: fit for purpose?

Abstract: This modified version of the Abbott Architect assay is clearly improved compared to the previous one and presents a better agreement with the LC-MS/MS.

Cited by 21 publications

References 8 publications

Time trends of vitamin D concentrations in northern Sweden between 1986 and 2014: a population-based cross-sectional study

Time trends of vitamin D concentrations in northern Sweden between 1986 and 2014: a population-based cross-sectional study

An Underestimation of 25-OH Vitamin D in Patients with Renal Disease by the Abbott Architect Immunoassay

Evaluation of the analytical performance of two vitamin D immunoassay methods

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