Knock down the mixture: Highly accurate breast milk tests will help monitor the development of babies

Russia is creating the first domestic series of diagnostic kits for working on special devices — tandem mass spectrometers - for accurate assessment of the level of hormones, vitamins, lipids, amino acids and other substances in the human body. This method allows you to determine the number of different compounds in the composition of mixtures. One of the first to be manufactured is a kit for the analysis of fatty acids in breast milk. This is necessary to control the development of infants, including premature babies. The introduction of such tests is an important step for the domestic laboratory diagnostic system, experts interviewed by Izvestia believe.

Analysis for mother and child

The staff of the Institute of Molecular Theranostics of the First Moscow State Medical University, together with the Sechenov Center for Motherhood and Childhood, are creating a series of specialized diagnostic kits for working on tandem mass spectrometers. In this method, several mass analyzers are used sequentially, which makes it possible to carry out structural analysis and identification of substances in mixtures with high accuracy.

In the future, the kits will be used in the country's clinical and diagnostic laboratories to accurately quantify the levels of hormones, vitamins, lipids, amino acids and other substances in the human body.

The goal of the project is to provide Russian clinical diagnostic laboratories with modern, standardized kits for the quantitative analysis of key biomarkers, which will reduce dependence on foreign reagents and equipment, the developers explained to Izvestia.

The first products, kits for the analysis of vitamins and polyunsaturated fatty acids in the blood, have already been tested on model and clinical samples.

According to Natalia Trifonova, Deputy Chief Physician for Science and Innovative Development at the Sechenov Center for Motherhood and Childhood, MD, Professor, as part of this research work, profiling is used not only for fatty acids and vitamins in blood serum, but also for fatty acids in breast milk, which is innovative.

All over the body: innovative bio-ink will accelerate the creation of custom organs

How a special hydrogel helps in regenerating damaged and printing new tissues

— Assessment of the state of fatty acid metabolism in the mother during lactation using high-performance liquid chromatography with tandem mass spectrometry allows you to individually select a diet or nutraceutical support. This is necessary to ensure the optimal supply of vital substances to the child, which is very important for his full development," the professor emphasized.

Upon successful completion of all stages of development and registration, the introduction of pilot panels into clinical practice is possible within two to three years. In the future, the developers plan to create panels for assessing hormonal profiles, cancer markers, metabolic disorders, and therapeutic drug monitoring (monitoring the concentration of drugs in the blood).

A step towards laboratory import independence

The kits being developed will allow laboratories to quickly introduce new types of research into routine practice, and doctors to obtain standardized and reproducible results using domestic technologies, explained Nikolay Eroshchenko, a chemist and expert at the Laboratory of Molecular Oncogenesis at the Institute of Molecular Theranostics at the Sechenov University Biomedical Science and Technology Park.

Unlike common enzyme immunoassay methods (ELISA), mass spectrometry accurately determines the mass of molecules, ensures high research speed and analysis specificity, and eliminates false cross-reactions. It can be used to measure dozens of substances in a single sample of biological material.

— Today in Russia there are only a few domestic kits for extended neonatal screening (includes in the Russian Federation the examination of all newborns for 36 diseases in the first days of life. Our task is to create a complete line that will meet the needs of laboratories in a wide variety of fields, from assessing hormonal profiles to monitoring drug concentrations," said Nikolay Eroshchenko.

The kits are being created primarily for the new Russian triple quadrupole chromatography-mass spectrometer, which is being developed at the National Research Nuclear University MEPhI in collaboration with Sechenov University and other partner organizations. But they will also be used for compatible devices that are used in clinical laboratories. Each solution is comprehensive and includes reagents, techniques and templates for data processing, which simplifies the implementation of the invention in practice.

A strategically important step

The creation of fully domestic kits for tandem mass spectrometry is a strategically important step, because in clinical diagnostics, a "method" is not only a device, but the entire chain: reagents, calibrators, internal standards, control materials, sample preparation protocol, software and quality regulations, the head of the Personalized Medicine center of excellence told Izvestia." Albert Rizvanov of Kazan (Volga Region) Federal University.

When this chain is localized, laboratories are less dependent on logistics and sanctions risks. This is especially critical for quantitative analyses, where a mistake in standardization turns into incorrect clinical decisions.

"As for the analysis of vitamins and fatty acids in the mother and in breast milk, its maximum practical value is in risk groups and in federal centers where difficult patients are treated: premature babies, malabsorption and metabolic disorders in the mother, severe dietary restrictions, and so on," the expert pointed out.

By changing the sample delivery methods and detection methods, it is possible to determine a very large volume of substances, said Natalia Baymeeva, Deputy Director for Quality, Head of Liquid Chromatography with Mass Spectrometry at Eurotest, market expert at NTI Helsnet.

From a different test: how Russian scientists are changing breast cancer treatment

The country has registered the first domestic test system for the selection of targeted treatment

— Of course, the problem of the lack of ready-made solutions in the field of mass spectrometry is very relevant for the Russian market. It is encouraging that some changes have begun, albeit in a narrow area. The protection of motherhood and childhood is very relevant for Russia, and if such decisions improve the situation, it cannot but be encouraging," the expert noted.

The development of such domestic diagnostic kits is a strategically right step, says Andrey Varivoda, market expert at NTI Helsnet and Chairman of the Board of Directors of Deacon Group of Companies.

— The method allows the detection and accurate measurement of substances in very low concentrations, which is necessary for the assessment of hormonal profiles, cancer markers and drugs. High sensitivity is also important for therapeutic drug monitoring, where the control of narrow therapeutic windows of drugs is critical," he noted.

However, for widespread implementation in routine practice, it is important that developers and the healthcare system answer two questions: who exactly is shown such profiling and how economically justified it is compared to simpler preventive strategies, Albert Rizvanov believes.

The project is being implemented within the framework of the "Priority 2030" program (the national project "Youth and Children").