Shanghai Chemtron Biotech Co.Ltd.

Current Status of Diagnostic Rapid Test Kit for Hepatitis B Virus Nucleic Acid Detection in China

With the advent and continuous application of real-time fluorescent quantitative PCR, the process of quantitative detection is greatly simplified, and the accuracy of quantitative detection is guaranteed. The commercial diagnostic rapid test kits produced by many manufacturers make the experiment more selective. The application of these diagnostic rapid test kits not only keeps the PCR technology sensitive and fast, but also overcomes the shortcomings of traditional PCR false positive contamination and the inability to accurately quantify. Real-time quantitative PCR is a molecular method for clinical detection of hepatitis B virus nucleic acid. Its specificity and sensitivity are difficult to achieve by other methods. However, the high sensitivity is a double-edged sword. On the one hand, it can detect very low concentrations of viruses in the body. On the other hand, improper operation or defective design of diagnostic rapid test kit may lead to false positive results. In order to avoid the occurrence of false positives and to ensure the accuracy of quantitative measurement results, it is necessary to evaluate and analyze the different diagnostic rapid test kit manufacturers and different batches of hepatitis B virus nucleic acid diagnostic rapid test kits for detection. Through the fluorescence quantitative PCR method, the correlation curve is established, and then the result data is used to evaluate from the indication error, the detection limit, the linearity and the repeatability, etc., to achieve the consistency of the quantitative determination results of the hepatitis B virus nucleic acid, and to ensure the accuracy of the diagnosis and treatment method of the hepatitis B patient. 
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