FIELD: medicine; biochemistry.
SUBSTANCE: described is a diagnostic test system (DTS) for determining a biomarker and a method for determining a biomarker specific for neurodegenerative diseases, including Alzheimer's disease, or neurodegenerative disorders, as well as use of said DTS for diagnosing neurodegenerative diseases or neurodegenerative disorders, including Alzheimer's disease. Test system includes: internal standard, which is (4S,7S,10S,13S)-4-((1H-imidazol-4-yl)methyl)-13-carbamoyl-10-(2-carboxyethyl)-7-methyl-2,5,8,11-tetraoxo-3,6,9,12-tetraazagexadecane-16 acid, labelled with 13C2 isotope, or (4S,7S,10S,13S)-4-((1H-imidazol-4-yl)methyl)-13-carbamoyl-10-(2-carboxyethyl)-7-methyl-2,5,8,11-tetraoxo-3,6,9,12-tetraazagexadecane-16 acid, labelled with 15N isotope, or (4S,7S,10S,13S)-4-((1H-imidazol-4-yl)methyl)-13-carbamoyl-10-(2-carboxyethyl)-7-methyl-2,5,8,11-tetraoxo-3,6,9,12-tetraazagexadecane-16 acid, labelled with D isotope, or (4S,7S,10S,13S)-4-((1H-imidazol-4-yl)methyl)-13-carbamoyl-10-(2-carboxyethyl)-7-methyl-2,5,8,11-tetraoxo-3,6,9,12-tetraazagexadecane-16 acid, labelled with 18O isotope, or combinations thereof; set of calibrators, which is a series of dilutions 4S,7S,10S,13S-4-((1H-imidazol-4-yl)methyl)-13-carbamoyl-10-(2-carboxyethyl)-7-methyl-2,5,8,11-tetraoxo-3,6,9,12-tetraazagexadecane-16 acid; signal quality control (QC) – series of solutions (48,78,108,138)-4-((1H-imidazol-4-yl)methyl)-13-carbamoyl-10-(2-carboxyethyl)-7-methyl-2,5,8,11-tetraoxo-3,6,9,12-tetraazagexadecane-16 acid of low, medium and high concentration.
EFFECT: invention enables high reproducibility of results and measurement accuracy of determining a biomarker specific for neurodegenerative diseases or neurodegenerative disorders, including Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis (ALS).
18 cl, 12 ex
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