Revista de Engenharia Biomédica e Dispositivos Médicos
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Solid-phase Immuno Radio Metric Assay (IRMA) of 25-hydroxy Vitamin D and Displacement from Serum Binding Proteins for Resource-limited Settings

Tshiband A, Mputu L, Tozin R, Ingala and Kiampa Philomene M

The development of a solid-phase immunoradiometric assay to satisfy the pressing need for a simple yet effective method for measuring 25-hydroxyvitamin D[25(OH)D] in a serum and thus more suited to routine use in clinical biochemical laboratories[1]. The aim of this study was not to compare our home made with commercially available method but tested for general assay performance, including homemade polyclonal antibody specificity. Methods: We used our home made radioiodine (125I)-based IRMA kit for the detection of 25(OH)D. It is based upon, non-competitive displacement agents which enable effective separation of vitamin D metabolites from binding proteins to enable the amount of vitamin D metabolites to be measured, without competing with the proteins or requiring its solvent extraction from the serum [2,3]. Results: Our package called: “cgea 25(OH)D-irma” is analytically, all qualities we expect from a good medical test kit, with a precision of coefficients below 13% as well as intra-series that in inter-series and inter-batch accuracy with a linearity estimated at 0.8ng/ml and good stability of the radio labeled trace (60 days) [4,5]. Conclusion: Simplification of the methods for extraction and separation has been a key feature in the improvement of assays for vitamin D in Democratic Republic of Congo. However, continuing efforts to improve laboratory performance vigilance with quality assurance programs are required and continuous efforts for improving the reliability of our homemade-test, such as regular internal QC are needed.