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Method evaluation study of a new generation of vitamin D assays
INTRODUCTION: Recently several diagnostic manufacturers have launched new 25-hydroxy-vitamin D (25[OH]D) assays, which are aligned to the National Institute of Standards and Technology (NIST) Standard Reference Materials (SRM) (NIST, Gaithersburg, Maryland). The aim of this study was to compare the...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Croatian Society of Medical Biochemistry and Laboratory Medicine
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4470105/ https://www.ncbi.nlm.nih.gov/pubmed/26110032 http://dx.doi.org/10.11613/BM.2015.020 |
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author | Enko, Dietmar Kriegshäuser, Gernot Stolba, Robert Worf, Elfriede Halwachs-Baumann, Gabriele |
author_facet | Enko, Dietmar Kriegshäuser, Gernot Stolba, Robert Worf, Elfriede Halwachs-Baumann, Gabriele |
author_sort | Enko, Dietmar |
collection | PubMed |
description | INTRODUCTION: Recently several diagnostic manufacturers have launched new 25-hydroxy-vitamin D (25[OH]D) assays, which are aligned to the National Institute of Standards and Technology (NIST) Standard Reference Materials (SRM) (NIST, Gaithersburg, Maryland). The aim of this study was to compare the performance of one liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, one enzyme linked immunosorbent assay (ELISA), and one recalibrated and previous version of a chemiluminescence immunoassay (CLIA). MATERIAL AND METHODS: Serum-aliquots of 198 patient samples from routine 25(OH)D analysis were measured by the ClinMass® LC-MS/MS Complete Kit (RECIPE Chemicals + Instruments GmbH, Munich, Germany), the ORGENTEC 25(OH)D(3)/D(2) ELISA (ORGENTEC Diagnostika GmbH, Mainz, Germany), the recalibrated Immunodiagnostic Systems (IDS)-iSYS 25(OH)D(S) and the previous used IDS-iSYS 25(OH)D CLIA (Immunodiagnostic Systems Ltd, Boldon, United Kingdom). Bland-Altman and Deming regression analyses were calculated for methods comparison of all tested 25(OH)D assays. The LC-MS/MS method was defined as the reference method. Within-run and between-run precision measurements were performed for all methods with three different concentration levels. RESULTS: Compared to the LC-MS/MS method, the new IDS-iSYS 25(OH)D(S) and ORGENTEC 25(OH)D(3)/D(2) assay demonstrated mean relative biases of 16.3% and 17.8%. The IDS-iSYS 25(OH)D assay showed the lowest mean bias of 1.5%. Deming regression analyses of the recalibrated IDS-iSYS 25(OH)D(S) and the ORGENTEC 25(OH)D(3)/D(2) assay showed proportional differences, when compared to the reference method. All assays showed a within-run and between-run imprecision of ≤ 20% at each of the evaluated concentration levels. CONCLUSIONS: The evaluated standardized immunoassays and LC-MS/MS are useful methods for measuring 25(OH)D serum-levels in clinical laboratories. |
format | Online Article Text |
id | pubmed-4470105 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Croatian Society of Medical Biochemistry and Laboratory Medicine |
record_format | MEDLINE/PubMed |
spelling | pubmed-44701052015-06-24 Method evaluation study of a new generation of vitamin D assays Enko, Dietmar Kriegshäuser, Gernot Stolba, Robert Worf, Elfriede Halwachs-Baumann, Gabriele Biochem Med (Zagreb) Research Article INTRODUCTION: Recently several diagnostic manufacturers have launched new 25-hydroxy-vitamin D (25[OH]D) assays, which are aligned to the National Institute of Standards and Technology (NIST) Standard Reference Materials (SRM) (NIST, Gaithersburg, Maryland). The aim of this study was to compare the performance of one liquid chromatography-tandem mass spectrometry (LC-MS/MS) method, one enzyme linked immunosorbent assay (ELISA), and one recalibrated and previous version of a chemiluminescence immunoassay (CLIA). MATERIAL AND METHODS: Serum-aliquots of 198 patient samples from routine 25(OH)D analysis were measured by the ClinMass® LC-MS/MS Complete Kit (RECIPE Chemicals + Instruments GmbH, Munich, Germany), the ORGENTEC 25(OH)D(3)/D(2) ELISA (ORGENTEC Diagnostika GmbH, Mainz, Germany), the recalibrated Immunodiagnostic Systems (IDS)-iSYS 25(OH)D(S) and the previous used IDS-iSYS 25(OH)D CLIA (Immunodiagnostic Systems Ltd, Boldon, United Kingdom). Bland-Altman and Deming regression analyses were calculated for methods comparison of all tested 25(OH)D assays. The LC-MS/MS method was defined as the reference method. Within-run and between-run precision measurements were performed for all methods with three different concentration levels. RESULTS: Compared to the LC-MS/MS method, the new IDS-iSYS 25(OH)D(S) and ORGENTEC 25(OH)D(3)/D(2) assay demonstrated mean relative biases of 16.3% and 17.8%. The IDS-iSYS 25(OH)D assay showed the lowest mean bias of 1.5%. Deming regression analyses of the recalibrated IDS-iSYS 25(OH)D(S) and the ORGENTEC 25(OH)D(3)/D(2) assay showed proportional differences, when compared to the reference method. All assays showed a within-run and between-run imprecision of ≤ 20% at each of the evaluated concentration levels. CONCLUSIONS: The evaluated standardized immunoassays and LC-MS/MS are useful methods for measuring 25(OH)D serum-levels in clinical laboratories. Croatian Society of Medical Biochemistry and Laboratory Medicine 2015-06-05 /pmc/articles/PMC4470105/ /pubmed/26110032 http://dx.doi.org/10.11613/BM.2015.020 Text en |
spellingShingle | Research Article Enko, Dietmar Kriegshäuser, Gernot Stolba, Robert Worf, Elfriede Halwachs-Baumann, Gabriele Method evaluation study of a new generation of vitamin D assays |
title | Method evaluation study of a new generation of vitamin D assays |
title_full | Method evaluation study of a new generation of vitamin D assays |
title_fullStr | Method evaluation study of a new generation of vitamin D assays |
title_full_unstemmed | Method evaluation study of a new generation of vitamin D assays |
title_short | Method evaluation study of a new generation of vitamin D assays |
title_sort | method evaluation study of a new generation of vitamin d assays |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4470105/ https://www.ncbi.nlm.nih.gov/pubmed/26110032 http://dx.doi.org/10.11613/BM.2015.020 |
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