Limitations of platform assays to measure serum 25OHD level impact on guidelines and practice decision making.
Metabolism
; 89: 1-7, 2018 12.
Article
em En
| MEDLINE
| ID: mdl-30227144
ABSTRACT
CONTEXT Liquid Chromatography Mass Spectroscopy (LC-MS/MS) is the preferred method to measure 25 hydroxyvitamin D (25OHD) levels, but laboratories are increasingly adopting automated platform assays. OBJECTIVE:
We assessed the performance of commonly used automated immunoassays, with that of LC-MS/MS, and the National Institute of Standards and Technology (NIST) reference values, to measure 25OHD levels. METHODS/SETTING:
We compared serum 25OHD levels obtained from 219 elderly subjects, enrolled in a vitamin D trial, using the Diasorin Liaison platform assay, and the tandem LC-MS/MS method. We also assessed the performance of the Diasorin and Roche automated assays, expressed as mean % bias from the NIST standards, based on the vitamin D External Quality Assessment Scheme (DEQAS) reports, from 2013 to 2017.RESULTS:
Serum 25OHD levels were significantly lower in the Diasorin compared to LC-MS/MS assay at baseline, 18.5⯱â¯7.8 vs 20.5⯱â¯7.6â¯ng/ml (pâ¯<â¯0.001), and all other time points. Diasorin (25OHD)â¯=â¯0.76â¯×â¯LC-MS/MS (25OHD)â¯+â¯4.3, R2â¯=â¯0.596. The absolute bias was independent of 25OHD values, and the pattern unfit for any cross-calibration. The proportion of subjects considered for vitamin D treatment based on pre-set cut-offs differed significantly between the 2 assays. There also was wide variability in the performance of both automated assays, compared to NIST reference values.CONCLUSION:
The performance of most widely used automated assays is sub-optimal. Our findings underscore the pressing need to re-consider current practices with regard to 25OHD measurements, interpretation of results from research studies, meta-analyses, the development of vitamin D guidelines, and their relevance to optimizing health.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vitamina D
/
Deficiência de Vitamina D
/
Tomada de Decisão Clínica
Tipo de estudo:
Guideline
/
Prognostic_studies
Limite:
Aged
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Metabolism
Ano de publicação:
2018
Tipo de documento:
Article
País de afiliação:
Líbano