GB/T 38165-2019 in English

Background and significance of standard formulation

Circulating free DNA (cfDNA) detection is of great value in precision medicine and disease monitoring. Accurate quantitative analysis of cfDNA concentration is achieved through real-time fluorescence PCR based on the highly conserved Alu sequence.

Technology Evolution Analysis

Traditional PCR technology requires electrophoresis detection after amplification, while real-time fluorescence PCR achieves real-time monitoring and quantitative analysis of the amplification process by continuously monitoring changes in fluorescence signals during the amplification process. This technological advancement has significantly improved detection efficiency and accuracy.

Implementation Recommendations

To ensure the accuracy and consistency of test results, in actual applications, the following should be done:

• Strictly follow standard operating procedures for sample extraction and PCR reaction system configuration.
• Regularly calibrate instruments to ensure stable performance of real-time fluorescence PCR instruments.
• Use validated standards to establish reliable standard curves.
• Strengthen biosafety protection measures to comply with GB/T19489 laboratory requirements.