J Clin Endocrinol Metab. 2012 Jan 11.
Barake M, Daher RT, Salti I, Cortas NK, Al-Shaar L, Habib RH, El-Hajj Fuleihan G.
Division of Endocrinology and Metabolism, Department of Internal Medicine (I.S., G.E.-H.F.); Department of Pathology and Laboratory Medicine (R.T.D., N.K.C.); Outcomes Research Unit (L.A.-S., R.H.H.); and Calcium Metabolism and Osteoporosis Program (G.E.-H.F.), American University of Beirut-Medical Center, Beirut 1107 2020, Lebanon.
Context:Laboratories are increasingly shifting to new automated 25-hydroxyvitamin D (25-OHD) assays, with subsequent variability in results.Objective/Setting:We describe the experience at our center with such a shift and illustrate its clinical implications.Methods:25-OHD levels were measured in 494 patients using Immunodiagnostic Systems RIA (IDS-RIA) and DiaSorin Liaison assays. Sources of variability between the assays were investigated in a subset of 83 samples, retested in the reference laboratory in the United States, and by reviewing the performance reports issued by the International Vitamin D External Quality Assessment Scheme, DEQAS. 25-OHD cut-points for target levels were used to compare the two assays.
Results:25-OHD concentrations were significantly lower when measured with Liaison as compared to IDS-RIA:
mean bias was -5 ng/ml,
range was -38.1 to 18.7 ng/ml, P < 0.001;
the absolute bias was independent of 25-OHD value.
Interassay variability was also detected in values obtained in the reference laboratory and in DEQAS reports.
- 52% of patients required treatment when tested by Liaison, as opposed to
- 36% by IDS-RIA (P < 0.001).
- 79 % and
- 64 %, respectively (P < 0.001).
The two assays agreed in only 41-68% of subjects, proportions that depended on criteria used to define agreement.
Conclusion:A change in 25-OHD assays has a significant impact on results, patient classification, and treatment recommendations.
Such variability cannot be ignored when deriving and applying vitamin D guidelines.
It also renders universal assay standardization a pressing call.
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So, when comparing your vitamin D test results to those from a different machine/lab:
Place only some trust in the most significant digit.
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- All items in category Vitamin D testing
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- Comparison of four current 25-hydroxyvitamin D assays
"official" deficiency of < 50 nmol/L= LC-MS/MS (44.6%) vs. ADVIA Centaur (51.6%), LIAISON (52.2%), Elecsys (37.6%)
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