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Application and Development Study of the Serum MIC-1 Immunoassay Kit

Author: FuChao
Tutor: QiJun
School: Beijing Union Medical College
Course: Clinical Laboratory Science
Keywords: Kit MIC-1 Tumor markers Diagnostic value
CLC: R730.4
Type: Master's thesis
Year: 2011
Downloads: 44
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Abstract


Objective: To establish the serum MIC-1 detection kit basic reaction system, evaluation kit for technical performance and clinical value of serum MIC-1 discussed as a tumor marker clinical value. Methods: The self-developed MIC-1 antigen and anti-MIC-1 antibody, developed by double antibody sandwich ELISA method as the core technology of serum MIC-1 detection kit; SFDA IVD based on the relevant provisions of the performance kit the assessment; application of the kit on a variety of malignant tumors, benign disease and normal control serum MIC-1 levels were detected evaluated serum MIC-1 levels in the diagnosis of malignant tumors of different clinical value and the analysis and evaluation of different tumor types, histological type, TNM stage, the relationship between treatment effect; through quantitative PCR ovarian cancer MIC-lmRNA levels and serum protein levels and the relationship between the comparison. Result: successful establishment of a double antibody sandwich ELISA for serum MIC-1 kit; kit stable period, the average recovery was 98.9% and between intra coefficients of variation were 9.51% and 5.15%, with RD Company research The kit correlation coefficient was 0.979. Pancreatic cancer, stomach cancer, esophageal cancer, colon cancer, lung cancer, serum MIC-1 levels were higher than the control group (P = 0.001) and benign disease group, MIC-1 has an important diagnostic value of these five tumors, better than the current commonly used in clinical CEA and CA199, particularly in the gastric cancer, colon cancer, esophageal cancer early diagnosis, MIC-1 show a good prospect. In colorectal and pancreatic cancer, MIC-1, respectively, combined with the CEA and CA199 diagnosis can improve the diagnostic sensitivity (41.8% vs 64.4%, 83.6% vs93.0%). Serum MIC-1 and tumor histological type and clinical TNM stage (P gt; 0.05). Effective treatment, serum MIC-1 levels decreased significantly compared to before treatment (P = 0.001), while serum MIC-1 in patients with relapsed and significantly higher levels (P = 0.001). Ovarian cancer tissue and serum levels of MIC-lmRNA protein levels exists between positive correlation (P = 0.009, r = 0.523), recurrent group MIC-lmRNA and protein levels were higher than the primary group, but not statistically significant (P = 0.682). Conclusion: Successful completion of the serum MIC-1 test kit development, analytical performance kit meet the requirements of in vitro diagnostic reagents; MIC-1 as a tumor marker has a good prospect, kits clinical value is higher.

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CLC: > Medicine, health > Oncology > General issues > Tumor diagnostics
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