Maya Rahme1, Laila Al-Shaar1, Ravinder Singh2, Rafic Baddoura3, Georges Halaby4, Asma Arabi1, Robert H Habib5, Rose Daher6, Darina Bassil1, Karim El-Ferkh1, Maha Hoteit1, Ghada El-Hajj Fuleihan7. 1. Department of Internal Medicine, Division of Endocrinology, Calcium Metabolism and Osteoporosis Program, WHO Collaborating Center for Metabolic Bone Disorders, American University of Beirut Medical Center, Beirut, Lebanon. 2. Division of Clinical Biochemistry and Immunology, Mayo Clinic Laboratories, Mayo Clinic, Rochester, MN, USA. 3. Department of Rheumatology, Hotel Dieu de France, St Joseph University, Beirut, Lebanon. 4. Department of Endocrinology, Hotel Dieu de France, St Joseph University, Beirut, Lebanon. 5. Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. 6. Department of Pathology & Laboratory Medicine, American University of Beirut Medical Center, Beirut, Lebanon. 7. Department of Internal Medicine, Division of Endocrinology, Calcium Metabolism and Osteoporosis Program, WHO Collaborating Center for Metabolic Bone Disorders, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address: gf01@aub.edu.lb.
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 ± 7.8 vs 20.5 ± 7.6 ng/ml (p < 0.001), and all other time points. Diasorin (25OHD) = 0.76 × LC-MS/MS (25OHD) + 4.3, R2 = 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.
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 ± 7.8 vs 20.5 ± 7.6 ng/ml (p < 0.001), and all other time points. Diasorin(25OHD) = 0.76 × LC-MS/MS (25OHD) + 4.3, R2 = 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.
Authors: G D Carter; J Berry; R Durazo-Arvizu; E Gunter; G Jones; J Jones; H L J Makin; P Pattni; K W Phinney; C T Sempos; E L Williams Journal: J Steroid Biochem Mol Biol Date: 2017-03-15 Impact factor: 4.292
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Authors: Rosemary L Schleicher; Maya R Sternberg; David A Lacher; Christoher T Sempos; Anne C Looker; Ramon A Durazo-Arvizu; Elizabeth A Yetley; Madhulika Chaudhary-Webb; Khin L Maw; Christine M Pfeiffer; Clifford Johnson Journal: Natl Health Stat Report Date: 2016-04-25
Authors: Maya Barake; Rose T Daher; Ibrahim Salti; Najwa K Cortas; Laila Al-Shaar; Robert H Habib; Ghada El-Hajj Fuleihan Journal: J Clin Endocrinol Metab Date: 2012-01-11 Impact factor: 5.958
Authors: Barbara Altieri; Etienne Cavalier; Harjit Pal Bhattoa; Faustino R Pérez-López; María T López-Baena; Gonzalo R Pérez-Roncero; Peter Chedraui; Cedric Annweiler; Silvia Della Casa; Sieglinde Zelzer; Markus Herrmann; Antongiulio Faggiano; Annamaria Colao; Michael F Holick Journal: Eur J Clin Nutr Date: 2020-01-06 Impact factor: 4.016