Public Health and clinical dilemmas resulting from imprecise vitamin D tests

Harrison, Simone L. , Nowak, Madeleine, Buettner, Petra G., Kimlin, Michael, Porter, David, Kennedy, R. Lee, and Speare, Richard (2009) Public Health and clinical dilemmas resulting from imprecise vitamin D tests. Journal of Rural and Tropical Public Health, 8. pp. 53-58.

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Objective: To determine whether there are clinical and public health dilemmas resulting from the reproducibility of routine vitamin D assays.

Methods: Blinded agreement studies were conducted in eight clinical laboratories using two commonly used assays to measure serum 25-hydroxyvitamin D (25(OH)D) levels in Australasia and Canada (DiaSorin Radioimmunoassay (RIA) and DiaSorin LIAISON® one).

Results: Only one laboratory measured 25(OH)D with excellent precision. Replicate 25(OH)D measurements varied by up to 97% and 15% of paired results differed by more than 50%. Thirteen percent of subjects received one result indicating insufficiency [25-50 nmol/l] and another suggesting adequacy [>50 nmol/l]). Agreement ranged from poor to excellent for laboratories using the manual RIA, while the precision of the semi-automated Liaison® system was consistently poor.

Conclusions: Recent interest in the relevance of vitamin D to human health has increased demand for 25(OH)D testing and associated costs. Our results suggest clinicians and public health authorities are making decisions about treatment or changes to public health policy based on imprecise data. Clinicians, researchers and policy makers should be made aware of the imprecision of current 25(OH)D testing so that they exercise caution when using these assays for clinical practice, and when interpreting the findings of epidemiological studies based on vitamin D levels measured using these assays. Development of a rapid, reproducible, accurate and robust assay should be a priority due to interest in population based screening programs and research to inform public health policy about the amount of sun exposure required for human health. In the interim, 25(OH)D results should routinely include a statement of measurement uncertainty.

Item ID: 10958
Item Type: Article (Research - C1)
ISSN: 1832-2921
Keywords: vitamin D assay; vitamin D deficiency; sun exposure; skin cancer; precision
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Date Deposited: 09 May 2010 22:47
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1117 Public Health and Health Services > 111706 Epidemiology @ 20%
11 MEDICAL AND HEALTH SCIENCES > 1199 Other Medical and Health Sciences > 119999 Medical and Health Sciences not elsewhere classified @ 80%
SEO Codes: 92 HEALTH > 9202 Health and Support Services > 920203 Diagnostic Methods @ 100%
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