At present, domestically developed ELISA kits have reached a level of quality and performance that is comparable to those from foreign countries. The data obtained using these kits meet the same technical standards, proving their reliability and effectiveness. This achievement marks a significant breakthrough in China's biotechnology sector, as it has successfully challenged the long-standing monopoly of imported enzyme-linked immunosorbent assay (ELISA) kits in the domestic market.
Today, there are five key factors that influence the accuracy and reliability of detection when using original R&D kits:
1. Tumor markers often exhibit both specific and non-specific characteristics, making them challenging to interpret consistently.
2. Tumors vary greatly in terms of stage, size, location, tissue origin, and metastatic potential, which can affect the detection outcomes significantly.
3. Antibodies used in the assays differ in type—such as polyclonal versus monoclonal antibodies—and also in terms of epitope recognition, affinity, and specificity, all of which impact test results.
4. Detection systems vary widely, including differences in detection principles, target markers, experimental conditions, techniques, instruments, and sensitivity levels, leading to variability in results.
5. Human factors also play a crucial role, including the professional expertise and technical experience of the operators, as well as laboratory conditions and the overall reliability of the testing process.
These factors highlight the complexity involved in developing and using ELISA kits for tumor marker detection, emphasizing the need for continuous improvement and standardization in both technology and practice.
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