Registration Number
0219U000055,
0117U006932
, R & D reports
Title
Development of an immunoenzyme test system for the determination of the hydroxylated form of vitamin D as a marker of vitamin D-deficiency state.
popup.stage_title
Head
Komisarenko S., Доктор біологічних наук
Registration Date
10-01-2019
Organization
A.V.Palladin Institute of Biochemistry of National Academy of Sciences
popup.description2
Five laboratory samples of the developed immunozyme test system for determining 25OНD were produced and the Acts on their manufacture were issued. A protocol was developed for conducting and establishing the analytical characteristics (specificity, sensitivity, reproducibility of results) of the test system samples and evaluating their effectiveness. It is shown that the sensitivity of the developed test system is 6.25 nmol/l. It is established that the variability of results reproduction (Intra CV) is within 5% with the maximum allowable value of 10%; The variability of results repeatability (Inter CV) is within 20%. It was revealed that hemoglobin, bilirubin and triacylglycerols in physiological concentrations do not have an interfering effect on the analysis procedure. A protocol was drawn up for the procedure and the analytical characteristics of the immunoenzyme reaction. The procedure for carrying out an immunoenzyme reaction has been validated using standard equipment for immunoenzyme analysis. A test of the developed immunodiagnostic for the quantitative determination of 25OНD in serum samples of experimental animals, healthy donors and patients with various diseases was conducted, which showed high efficiency of the test system and low variability of the results obtained. Instructions for use of the test system was developed.
Product Description
popup.authors
Великий Микола Миколайович
Дробот Людмила Борисівна
Колеснікова Ірина Миколаївна
Лісаковська Ольга Олександрівна
Мазанова Анна Олександрівна
Шиманський Ігор Олександрович
popup.nrat_date
2020-04-02
