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ISSN 2410-7751 (Print)
ISSN 2410-776X (on-line)

 2 2016

"Biotechnologia Acta" V. 9, No 2, 2016
https://doi.org/10.15407/biotech9.02.028
Р. 28-36, Bibliography 33, English
Universal Decimal Classification: 557.161.2+612.017.1:616-097

DEVELOPMENT AND VALIDATION OF IMMUNOENZYME TEST-SYSTEM FOR DETERMINATION OF 25-HYDROXYVITAMIN D IN BLOOD SERUM

A. O. Mazanova, I. O. Shymanskyy, M. M. Veliky

Palladin Institute of Biochemistry of NAS of Ukraine, Kyiv

The   present   study   was   aimed   at   designing   of   immunoenzyme   test-system   for   competitive determination  of  25OHD  in  blood  serum  using  polyclonal  antibodies  against  25OHD  and  biotin-streptavidin  visualization  technique.  The  validation  parameters  of  test-system  were  determined.  For  development of test-system we used the preparation of specific antibodies against 25OHD with the titer 1:3000.  The  optimal  concentration  of  competing  agent  (25OHD3-LC-biotin)  was  found  to  be  equal to 5 ng/ml. The standard calibration curve was built by using a set of seven calibrators. For the validation of  test-system  the  following  parameters  were  established:  limit  of  detection,  quantitative  limit,  cross-reactivity,  intra-  and  inter-system  coefficients  of  variation  (Intra.CV,  Inter.CV)  and  “matrix  effect”.  Constructed  immunoenzyme  test-system  can  be  used  successfully  for  25OHD  determination  in  blood  serum samples.

Key words: 25-Hydroxyvitamin D3, immunoenzyme analysis, polyclonal antibodies.

© Palladin Institute of Biochemistry of National Academy of Sciences of Ukraine, 2016