Abstract
Background:
We provide a clinical and analytical evaluation of the reformulated version of the Abbott Architect 25-hydroxyvitamin D assay. We compared this assay with three commercial automated immunoassays and against a VDSP-traceable liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in six different populations. We also supplemented 40 healthy volunteers with either 600,000 IU of vitamin D2 or 100,000 of vitamin D3 to evaluate the performance of the immunoassays vs. the LC-MS/MS.
Methods:
Precision and limit of quantification were assessed, 25(OH)D2 and C3-epimer recovery were calculated. Two hundred and forty samples obtained in healthy Caucasians and Africans, osteoporotic, hemodialyzed and intensive care patients and 3rd trimester pregnant women were analyzed by all methods. Correlation was studied using Passing-Bablok and Bland-Altman analysis. Concordance correlation coefficient (CCC) was calculated to evaluate agreement between immunoassays and LC-MS/MS. We verified if patients were homogeneously classified with the immunoassays when they took vitamin D2 or vitamin D3 after 1, 7 and 28 days.
Results:
We observed excellent analytical features and showed a very good correlation to the LC-MS/MS results in the overall population. Compared to the other immunoassays, concordance of the new Abbott assay with the LC-MS/MS was at least similar, and often better in diseased populations. Althought the cross-reactivity with 25(OH)D2 was not of 100%, there was no significant difference in the classifications of the patients, either supplemented with D2 or D3 or after 7 or 28 days.
Conclusions:
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.
References
1. Holick MF. Vitamin D deficiency. N Engl J Med 2007;357:266–81.10.1056/NEJMra070553Search in Google Scholar PubMed
2. Sempos CT, Vesper HW, Phinney KW, Thienpont LM, Coates PM. Vitamin D status as an international issue: national surveys and the problem of standardization. Scand J Clin Lab Invest Suppl 2012;243:32–40.Search in Google Scholar
3. Cavalier E, Carlisi A, Bekaert A-C, Rousselle O, Chapelle J-P, Souberbielle JC. Analytical evaluation of the new Abbott Architect 25-OH vitamin D assay. Clin Biochem 2012;45:505–8.10.1016/j.clinbiochem.2012.01.021Search in Google Scholar PubMed
4. NCCLS. Evaluation of precision performance of quantitative measurement methods, approved guideline, EP05-A2, ISBN 1-56238-542-9. n.d.Search in Google Scholar
5. Wielders JP, Wijnberg FA. Preanalytical stability of 25(OH)-vitamin D3 in human blood or serum at room temperature: solid as a rock. Clin Chem 2009;55:1584–5.10.1373/clinchem.2008.117366Search in Google Scholar PubMed
6. Le Goff C, Peeters S, Crine Y, Lukas P, Souberbielle JC, Cavalier E. Evaluation of the cross-reactivity of 25-hydroxyvitamin D2 on seven commercial immunoassays on native samples. Clin Chem Lab Med 2012;50:2031–2.10.1515/cclm-2012-0164Search in Google Scholar PubMed
7. Cavalier E, Wallace AM, Carlisi A, Chapelle J-P, Delanaye P, Souberbielle J-C. Cross-reactivity of 25-hydroxy vitamin D2 from different commercial immunoassays for 25-hydroxy vitamin D: an evaluation without spiked samples. Clin Chem Lab Med 2011;49:555–8.10.1515/CCLM.2011.072Search in Google Scholar PubMed
8. Lin LI. A concordance correlation coefficient to evaluate reproducibility. Biometrics 1989;45:255–68.10.2307/2532051Search in Google Scholar
9. Mcbride GB. A proposal for strength-of-agreement criteria for Lin’s Concordance Correlation Coefficient. NIWA Client Rep 2005;HAM2005-06:14.Search in Google Scholar
10. Cavalier E, Lukas P, Crine Y, Peeters S, Carlisi A, Le Goff C, et al. 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;431:60–5.10.1016/j.cca.2014.01.026Search in Google Scholar PubMed
11. Cavalier E, Lukas P, Bekaert A-C, Peeters S, Le Goff C, Yayo E, et al. Analytical and clinical evaluation of the new Fujirebio Lumipulse®G non-competitive assay for 25(OH)-vitamin D and three immunoassays for 25(OH)D in healthy subjects, osteoporotic patients, third trimester pregnant women, healthy African subjects, hemodia. Clin Chem Lab Med 2016;54:1347–55.10.1515/cclm-2015-0923Search in Google Scholar PubMed
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