Limitations of platform assays to measure serum 25OHD level impact on guidelines and practice decision making

Maya Rahme, Laila Al-Shaar, Ravinder Jit Singh, Rafic Baddoura, Georges Halaby, Asma Arabi, Robert H. Habib, Rose Daher, Darina Bassil, Karim El-Ferkh, Maha Hoteit, Ghada El-Hajj Fuleihan

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1-7
Number of pages7
JournalMetabolism: Clinical and Experimental
Volume89
DOIs
StatePublished - Dec 1 2018

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Practice Guidelines
Vitamin D
Decision Making
Technology
Serum
Reference Values
Immunoassay
Liquid Chromatography
Calibration
Meta-Analysis
Mass Spectrometry
Guidelines
Health
Research
Therapeutics

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Limitations of platform assays to measure serum 25OHD level impact on guidelines and practice decision making. / Rahme, Maya; Al-Shaar, Laila; Singh, Ravinder Jit; Baddoura, Rafic; Halaby, Georges; Arabi, Asma; Habib, Robert H.; Daher, Rose; Bassil, Darina; El-Ferkh, Karim; Hoteit, Maha; El-Hajj Fuleihan, Ghada.

In: Metabolism: Clinical and Experimental, Vol. 89, 01.12.2018, p. 1-7.

Research output: Contribution to journalArticle

Rahme, M, Al-Shaar, L, Singh, RJ, Baddoura, R, Halaby, G, Arabi, A, Habib, RH, Daher, R, Bassil, D, El-Ferkh, K, Hoteit, M & El-Hajj Fuleihan, G 2018, 'Limitations of platform assays to measure serum 25OHD level impact on guidelines and practice decision making', Metabolism: Clinical and Experimental, vol. 89, pp. 1-7. https://doi.org/10.1016/j.metabol.2018.09.003
Rahme, Maya ; Al-Shaar, Laila ; Singh, Ravinder Jit ; Baddoura, Rafic ; Halaby, Georges ; Arabi, Asma ; Habib, Robert H. ; Daher, Rose ; Bassil, Darina ; El-Ferkh, Karim ; Hoteit, Maha ; El-Hajj Fuleihan, Ghada. / Limitations of platform assays to measure serum 25OHD level impact on guidelines and practice decision making. In: Metabolism: Clinical and Experimental. 2018 ; Vol. 89. pp. 1-7.
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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.",
author = "Maya Rahme and Laila Al-Shaar and Singh, {Ravinder Jit} and Rafic Baddoura and Georges Halaby and Asma Arabi and Habib, {Robert H.} and Rose Daher and Darina Bassil and Karim El-Ferkh and Maha Hoteit and {El-Hajj Fuleihan}, Ghada",
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AU - Rahme, Maya

AU - Al-Shaar, Laila

AU - Singh, Ravinder Jit

AU - Baddoura, Rafic

AU - Halaby, Georges

AU - Arabi, Asma

AU - Habib, Robert H.

AU - Daher, Rose

AU - Bassil, Darina

AU - El-Ferkh, Karim

AU - Hoteit, Maha

AU - El-Hajj Fuleihan, Ghada

PY - 2018/12/1

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N2 - 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.

AB - 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.

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