Two-site evaluation of the Roche Elecsys Vitamin D total III assay.
Clin Chem Lab Med
; 60(10): 1598-1606, 2022 09 27.
Article
em En
| MEDLINE
| ID: mdl-35849629
ABSTRACT
OBJECTIVES:
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.METHODS:
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)2D3 and 3-epi-25(OH)D3, and outlier rate were evaluated for the Elecsys Vitamin D total III assay.RESULTS:
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)2D3 and 3-epi-25(OH)D3 was weak or modest in available patient samples. However, using SRM972a with a high level of 3-epi-25(OH)D3 (enriched) revealed an important cross-reactivity with both Roche Elecsys Vitamin D total II and III assays (+74.7% and +73.7%).CONCLUSIONS:
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)D3 is still problematic in high titer samples.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vitamina D
/
Espectrometria de Massas em Tandem
Limite:
Humans
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article