Two-site evaluation of the Roche Elecsys Vitamin D total III assay.
25(OH)D
immunoassay
liquid chromatography tandem mass spectrometry (LC-MS/MS)
vitamin D
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
27 09 2022
27 09 2022
Historique:
received:
25
02
2022
accepted:
03
07
2022
pubmed:
19
7
2022
medline:
31
8
2022
entrez:
18
7
2022
Statut:
epublish
Résumé
The high request for vitamin D testing in the last decades has led manufacturers to develop assays on automated immunoassay platforms. The objective of this study was to evaluate the performance of the new Elecsys Vitamin D total III assay for the measurement of total 25(OH)D. A total of 844 serum samples collected in two clinical laboratories were used to evaluate the new Roche Elecsys Vitamin D total III assay. Comparisons with Roche Elecsys Vitamin D total II and liquid chromatography tandem mass spectrometry (LC-MS/MS) were carried out. Additionally, assay imprecision, linearity, matrix effects, biotin interference, cross-reactivity with 24,25(OH) Only the comparison between LC-MS/MS and Roche Elecsys Vitamin D total III achieved the optimal specification for bias (i.e., <3.4%). Imprecision, linearity and matrix effects showed acceptable results. The biotin interference threshold was increased up to 1,200 ng/mL and the outlier rate was low (0.26%). The cross-reactivity with 24,25(OH) In conclusion, the Roche Elecsys Vitamin D total III assay presents several advantages compared to the previous assay generation: higher biotin interference threshold, broader measuring range, and better comparability with LC-MS/MS. However, the cross-reactivity toward 3-epi-25(OH)D
Identifiants
pubmed: 35849629
pii: cclm-2022-0177
doi: 10.1515/cclm-2022-0177
doi:
Substances chimiques
Vitamins
0
Vitamin D
1406-16-2
Biotin
6SO6U10H04
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1598-1606Informations de copyright
© 2022 Walter de Gruyter GmbH, Berlin/Boston.
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