The Development Of Accurate Quantitative Method For Clinical Disease Markers

The human chorionic gonadotropin (hCG), C-reactive protein (CRP), C-Peptide are important clinical disease markers. In the clinical laboratory, clinical tests make important significance for the determination of health, diagnosis of the disease, and treatment plan formulation. But currently, the detection method of these three markers are complex, tedious. And there is no standardized test method. The test results is not stable and different test methods are not comparable. Its brought difficulties to the diagnosis and treatment of disease. This research firstly established the human chorionic gonadotropins, c-reactive protein, c-peptide standard quantitative methods that based on the isotope dilution mass spectrometry(IDMS). And this research made the evaluation of uncertainty about these established standard method. The mass fraction of hCG is0.6126g·g-1(expanded uncertainty=0.016g·g-1， κ=2). And the mass fraction of C-Peptide is0.8207g·g-1(expanded uncertainty=0.030g·g-1, k=2). And meanwhile accurately quantitating the content of the signature peptides of c-reactive protein provides standard method support for serum CRP. Its provides a standards method for clinical detection of these three clinical makers and fills in the absence of accurate analytical of hCG, CRP, C-Peptide.Meanwhile, the establishment of the two quantitative methods of mass balance method and quantitative nuclear magnetic resonance to detect Vitamin K1. The value of Vitamin K1was99.2%, with the relative expanded uncertainty of0.6%. It is meaningful in clinical diagnose. Furthermore, lyophilization vitamin K1was analyzed by gravimetric-HPLC method, which makes the vitamin K1as the standard material. The certified value was0.96mg·mL-1, with the relative expanded uncertainty of7%. It will assure the accuracy of determination of vitamin K1And meanwhile lyophilization vitamin K1was analyzed by gravimetric-HPLC method, which makes the vitamin K1as the standard material. The certified value was0.96mg·mL-1, with the relative expanded uncertainty of7%. The successful of this research provide the standard quantification method for these disease and make favourable support for the storage of standard materials.