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Information × 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 Close