GB/T 37875-2019 in English

Background and significance of standard formulation

The formulation of GB/T 37875—2019 aims to unify the quality evaluation system of nucleic acid extraction and purification kits, standardize industry technical requirements, and ensure the high quality of kits in the production, application and service process. This standard is applicable to the production and quality control of DNA and RNA extraction and purification kits such as bacteria, plasmids, and eukaryotic cells.

With the development of biotechnology, nucleic acid extraction and purification technology is widely used in genetic testing, medical diagnosis, and biological research. This standard provides the industry with a set of scientific quality evaluation methods, which helps to improve product quality and technical level.

Comparative analysis of standard frameworks

Quality evaluation indicators and implementation recommendations

Implementation Recommendations and Best Practices

1. Strictly control experimental conditions: Ensure that multiple parallel tests are performed under reproducible conditions (same operator, same equipment, same batch of kits) and calculate the relative standard deviation (RSD).
2. Establish a quality traceability system: Evaluate the batch differences of different batches of kits to ensure product quality consistency. Refer to formula (3) to calculate the inter-batch RSD value.
3. Optimize the detection method: In the absence of standard substances, use sufficiently uniform samples instead, and combine multiple detection methods (such as fluorescence and electrophoresis) to improve the accuracy of the results.
4. Strengthen personnel training: Improve the operator's understanding of the extraction requirements of different sample types to ensure the reliability and consistency of experimental data.