Comparison of four routinely used vitamin D automated immunoassays
Status PubMed-not-MEDLINE Jazyk angličtina Země Srbsko Médium print
Typ dokumentu časopisecké články
PubMed
34177372
PubMed Central
PMC8199437
DOI
10.5937/jomb0-27531
PII: jomb-40-3-2103277W
Knihovny.cz E-zdroje
- Klíčová slova
- 25(OH)-vitamin D, Architect, Cobas, Liaison, Unicel, method comparison, vitamin D,
- Publikační typ
- časopisecké články MeSH
BACKGROUND: To compare four automated immunoassays for the measurement of 25(OH)-vitamin D (25-OHD) and to assess the impact on the results obtained from a healthy population. METHODS: We analysed 100 serum samples on Unicel DxI 800 (Beckman Coulter), Architect i1000 (Abbott), Cobas e411 (Roche) and Liaison XL (DiaSorin). Passing-Bablok regression and Bland-Altman plots were used for method comparison. In order to categorise the obtained values, results were categorised into the following groups: 0-25 nmol/L, 25-50 nmol/L, 50-75 nmol/L and above 75 nmol/L and compared. The percentage of samples below 75 nmol/L, and below 50 nmol/L was then calculated for every method. RESULTS: According to paired comparisons, each method differs from others (p<0.0001) except Cobas vs Architect, which do not show a statistically significant difference (p=0.39). The strongest correlation was found between Liaison and Architect (ρ=0.94, p<0.0001). The percentage of samples below the recommended value of 75 nmol/L were: 70% (Architect), 92% (Liaison), 71% (Cobas) and 89% (Unicel). The percentage of samples below the value of 50 nmol/L were: 17% (Architect), 55% (Liaison), 28% (Cobas) and 47% (Unicel). CONCLUSIONS: The observed differences stem from the use of different analytical systems for 25-OHD concentration analysis and can result in different outcomes. The recommended values should be established for each assay in accordance with the data provided by the manufacturer or in the laboratory, in accordance with proper standardisation.
UVOD: Cilj je bio da se uporede četiri automatizovana imunotesta za merenje 25(OH)-vitamina D (25-OHD) i da se proceni uticaj na rezultate dobijene na uzorku zdrave populacije. METODE: Analizirali smo 100 uzoraka seruma na analizatorima Unicel DxI 800 (Beckman Coulter), Architect i1000 (Abbott), Cobas e411 (Roche) i Liaison KSL (DiaSorin). Za upoređivanje metoda su korišćene Passing-Bablok-ova regresija i Bland-Altman-ovi plotovi. Da bi se dobijene vrednosti kategorizovale, rezultati su kategorisani u sledeće grupe: 0-25 nmol/L, 25-50 nmol/L, 50-75 nmol/L i iznad 75 nmol/L i posle toga upoređeni. Potom je izračunat procenat uzoraka ispod 75 nmol/L i ispod 50 nmol/L za svaku metodu. REZULTATI: Prema uparenim poređenjima, svaka metoda se razlikuje od ostalih (p <0,0001), osim u slučaju kada se porede rezultati analizatora Cobas i Architect, koji ne pokazuju statistički značajnu razliku (p = 0,39). Najsnažnija korelacija je uočena između Liason i Architect (ρ = 0,94, p <0,0001). Procenat uzoraka ispod preporučene vrednosti od 75 nmol/L je bio: 70% (Architect), 92% (Liaison), 71% (Cobas) i 89% (Unicel). Procenat uzoraka ispod vrednosti od 50 nmol/L je bio: 17% (Architect), 55% (Liaison), 28% (Cobas) i 47% (Unicel). ZAKLJUČAK: Uočene razlike potiču od upotrebe različitih analitičkih sistema za analizu koncentracije 25-OHD i mogu da rezultiraju različitim ishodima. Preporučene vrednosti treba da budu utvrđene za svaki test u skladu sa podacima koje je dostavio proizvođač ili u laboratoriji, u skladu sa odgovarajućom standardizacijom.
University Hospital Pilsen 2nd Internal Clinic Czech Republic
University Hospital Pilsen Department of Immunochemistry Diagnostics Czech Republic
University Hospital Pilsen Institute of Clinical Biochemistry and Hematology Czech Republic
Zobrazit více v PubMed
Adams J S, Hewison M. Update in Vitamin D. J Clin Endocrinol Metab. 2010;95(2):471. doi: 10.1210/jc.2009-1773. PubMed DOI PMC
Herrmann M. The measurement of 25-hydroxy vitamin D: An analytical challenge. Clin Chem Lab Med. 2012;50(11):1873. doi: 10.1515/cclm-2012-0526. PubMed DOI
Ferrari D, Lombardi G, Banfi G. Concerning the vitamin D reference range: Pre-analytical and analytical variability of vitamin D measurement. Biochem Med (Zagreb) 2017;27(3) doi: 10.11613/bm.2017.030501. PubMed DOI PMC
Wallace A M, Gibson S, de la Hunty A, Lamberg-Allardt C, Ashwell M. Measurement of 25-hydroxyvitamin D in the clinical laboratory: Current procedures, performance characteristics and limitations. Steroids. 2010;75(7):477. doi: 10.1016/j.steroids.2010.02.012. PubMed DOI
Sempos C T, Betz J M, Camara J E, Carter G D, Cavalier E, Clarke M W, Dowling K G, Durazo-Arvizu R A, Hoofnagle A N, Liu A, Phinney K W, Sarafin K, Wise S A, Coates P M. General Steps to Standardize the Laboratory Measurement of Serum Total 25-Hydroxyvitamin D. J AOAC Int. 2017;100(5):1230. doi: 10.5740/jaoacint.17-0259. PubMed DOI
Durazo-Arvizu R A, Tian L, Brooks S P J, Sarafin K, Cashman K D, Kiely M, Merkel J, Myers G L, Coates P M, Sempos C T. The Vitamin D Standardization Program (VDSP) Manual for Retrospective Laboratory Standardization of Serum 25-Hydroxyvitamin D Data. J AOAC Int. 2017;100(5):1234. doi: 10.5740/jaoacint.17-0196. PubMed DOI
Holick M F, Binkley N C, Bischoff-Ferrari H A, Gordon C M, Hanley D A, Heaney R P, Murad H M, Weaver C M. Evaluation, Treatment, and Prevention of Vitamin D Deficiency: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2011;96(7):1911. doi: 10.1210/jc.2011-0385. PubMed DOI
Cashman K D, Dowling K G, Škrabáková Z, Gonzalez-Gross M, Valtueña J, de Henauw S, Moreno L, Damsgaard C T, Michaelsen K F, Mølgaard C, Jorde R, Grimnes G, Moschonis G. Vitamin D deficiency in Europe: Pandemic? Am J Clin Nutr. 2016;103(4):1033. doi: 10.3945/ajcn.115.120873. PubMed DOI PMC
Lai J K C, Lucas R M, Banks E, Ponsonby A l L, Ausimmune Investigator Group Variability in vitamin D assays impairs clinical assessment of vitamin D status. Intern Med J. 2012;42(1):43. doi: 10.1111/j.1445-5994.2011.02471.x. PubMed DOI
Nowson C A, Mcgrath J J, Ebeling P R, Haikerwal A, Daly R M, Sanders K M, Seibel M J, Mason R S. Vitamin D and health in adults in Australia and New Zealand: A position statement. Med J Aust. 2012;196(11):686. doi: 10.5694/mja11.10301. PubMed DOI
Vuistiner P, Rousson V, Henry H, Lescuyer P, Boulat O, Gaspoz J, Mooser V, Vollenweider P, Waeber G, Cornuz J, Paccaud F, Bochud M, Guessous I. A Population-Based Model to Consider the Effect of Seasonal Variation on Serum 25(OH)D and Vitamin D Status. Biomed Res Int. 2015 doi: 10.1155/2015/168189. PubMed DOI PMC
Ricos C, Alvarez V, Cava F, et al. Current databases on biological variation: Pros, cons and progress. Scand J Clin Lab Invest. 1999;59:491–500. PubMed
13. European Federation of Clinical Chemistry and Laboratory Medicine EFLM Biological Variation Database https://biologicalvariation.eu/ [July 23, 2019]. https://biologicalvariation.eu/
Viljoen A, Singh D K, Farrington K, Twomey P J. Analytical quality goals for 25-vitamin D based on biological variation. J Clin Lab Anal. 2011;25(2):130. doi: 10.1002/jcla.20446. PubMed DOI PMC
Sempos C T, Heijboer A C, Bikle D D, Bollerslev J, Bouillon R, Brannon P M, Deluca H F, Jones G, Munns C F, Bilezikian J P, Giustina A, Binkley N. Vitamin D assays and the definition of hypovitaminosis D: Results from the First International Conference on Controversies in Vitamin D. Br J Clin Pharmacol. 2018;84(10):2194. doi: 10.1111/bcp.13652. PubMed DOI PMC
Stöckl D, Sluss P M, Thienpont L M. Specifications for trueness and precision of a reference measurement system for serum/plasma 25-hydroxyvitamin D analysis. Clin Chim Acta. 2009;408(1-2):8. doi: 10.1016/j.cca.2009.06.027. PubMed DOI
Ozcan N, Ucar F, Arzuhal A E, Bulut E, Ozturk A, Taslipinar Y M, Temel I, Erden G. Evaluation of the analytical performance of Unicel DXI 800 for the Total 25 (OH) Vitamin D measurements. Clin Biochem. 2016;49(6):486. doi: 10.1016/j.clinbiochem.2015.11.022. PubMed DOI
Carter G D, Berry J, Durazo-Arvizu R, Gunter E, Jones G, Jones J, Makin H L J, Pattni P, Phinney K W, Sempos C T, Williams E L. Quality assessment of vitamin D metabolite assays used by clinical and research laboratories. J Steroid Biochem Mol Biol. 2017;173:100–104. doi: 10.1016/j.jsbmb.2017.03.010. PubMed DOI
Carter G, Walker E. Deqas review 2016/2017 2017:1–23.
Heijboer A C, Blankenstein M A, Kema I P, Buijs M M. Accuracy of 6 Routine 25-Hydroxyvitamin D Assays: Influence of Vitamin D Binding Protein Concentration. Clin Chem. 2012;58(3):543. doi: 10.1373/clinchem.2011.176545. PubMed DOI
Sezgin G, Ozturk G, Turkal R, Caykara B. Vitamin D levels of outpatients admitted to a University Hospital in the Marmara region of Turkey over 3 years. J Med Biochem. 2019;38(2):181. doi: 10.2478/jomb-2018-0027. PubMed DOI PMC
Cavalier E, Lukas P, Crine Y, Peeters S, Carlisi A, Le G C, Gadisseur R, Delanaye P, Souberbielle J. Evaluation of automated immunoassays for 25(OH)-vitamin D determination in different critical populations before and after standardization of the assays. Clin Chim Acta. 2014;431:60–65. doi: 10.1016/j.cca.2014.01.026. PubMed DOI
Binkley N, Dawson-Hughes B, Durazo-Arvizu R, Thamm M, Tian L, Merkel J M, Jones J C, Carter G D, Sempos C T. Vitamin D measurement standardization: The way out of the chaos. J Steroid Biochem Mol Biol. 2017;173:117–121. doi: 10.1016/j.jsbmb.2016.12.002. PubMed DOI