Аннотация
В свете современных знаний о роли витамина D в метаболизме, актуально лабораторное определение уровня его содержа-
ния в крови пациентов.
Цель работы – разработка экспресс набора для лабораторного количественного/полуколичественного исследования актив-
ных метаболитов витамина D в крови человека.
Материалы и методы. Технология иммунохроматографического полуколичественного исследования целевого аналита в кро-
ви и обеспечение процесса исследования иммуноактивными соединениями.
Результаты. Разработан новый набор «Тест-система иммунохроматографическая для полуколичественного определения
множественных форм 25-гидроксивитамина D в цельной капиллярной крови человека «ИХА-Витамин D-полуколичественный»,
позволяющий оценивать содержания 25(ОН)D по 3 градуирующим уровням: дефицит (D <10 нг/мл), недостаточный (10≤ D
<30 нг/мл) и достаточный (30≤ D <100 нг/мл). Технические доклинические испытания нового набора с набором реагентов
сравнения и верифицирующие иммуноферментные исследования продемонстрировали высокие показатели клинической чув-
ствительности, специфичности и воспроизводимости результатов. Установлено отсутствие потенциально интерфериру-
ющего влияния на результаты ИХА со стороны ряда активных соединений энлогенной и экзогенной природы.
3аключение. Набор рекомендован для использования в медицинских учреждениях РФ и при самотестировании населением
(РУ № РЗН 2023/21510 от 10.11.2023 г.).
Annotation
In light of current knowledge about the role of vitamin D, laboratory determination of its level in patients’ blood is relevant.
The aim of the work is to develop an express kit for laboratory quantitative/semi-quantitative study of active metabolites of vitamin
D in human blood.
Materials and methods. Technology of immunochromatographic semi-quantitative study of the target analyte in blood and providing
the study process with immunoactive compounds.
Results. A new kit «Immunochromatographic test system for semi-quantitative determination of multiple forms of 25-hydroxyvitamin
D in human whole capillary blood «ICA-Vitamin D-semi-quantitative» has been developed, which allows to estimate the content
of 25(OH)D by 3 graduated levels: deficiency (D <10 ng/ml), insufficient (10≤ D <30 ng/ml) and sufficient (30≤ D <100 ng/ml).
Technical preclinical tests of the new kit with a set of comparison reagents and verifying enzyme immunoassays demonstrated high
rates of clinical sensitivity, specificity and reproducibility of the results. The absence of a potential interfering effect on the results of
ICA from a number of active compounds of enogenic and exogenous nature was established.
Conclusion. The kit is recommended for use in medical institutions of the Russian Federation and for self-testing by the population
(RU No. RZN 2023/21510 dated 11/10/2023).
Key words: laboratory diagnostics; vitamin D; 25(OH)D; immunochromatography; reagent kit
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