Analytical and clinical validation of a radioimmunoassay for the measurement of 1,25 dihydroxy vitamin D
Objectives: The analytical and clinical validation of the DiaSorin 1,25 dihydroxyvitamin D RIA is described. Design and Methods: The analytical parameters assessed included analytical sensitivity, dilution linearity, intra- and inter-assay precision, recovery, specificity, and interference studies....
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Published in | Clinical biochemistry Vol. 35; no. 7; pp. 517 - 521 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Elsevier Inc
01.10.2002
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Subjects | |
Online Access | Get full text |
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Summary: | Objectives: The analytical and clinical validation of the DiaSorin 1,25 dihydroxyvitamin D RIA is described.
Design and Methods: The analytical parameters assessed included analytical sensitivity, dilution linearity, intra- and inter-assay precision, recovery, specificity, and interference studies. Where appropriate, assessments were performed according to NCCLS guidelines. The clinical validation assessed normal individuals and end-stage renal disease patients.
Results: The analytical sensitivity of the assay is < 2.0 pg/mL or < 4.8 pM. The assay is specific for both 1,25 dihydroxyvitamin D2 and D3. Recovery ranged from 97% to 108% for spiked samples. Intra-assay precision, as %CV, ranged from 7% to 11%, while inter-assay precision was 12% to 15%. No interference was observed from bilirubin, cholesterol, hemoglobin, or triglycerides. Clinical validation demonstrated complete discrimination between normal and ESRD populations.
Conclusions: These data demonstrate that the DiaSorin 1,25 (OH)
2 vitamin D RIA is a robust, accurate, and precise tool for the assessment of 1,25 (OH)
2 vitamin D. |
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Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
ISSN: | 0009-9120 1873-2933 |
DOI: | 10.1016/S0009-9120(02)00378-8 |