Early cancer screening and when patients with advanced cancer cannot obtain tumor tissue, they must rely on free tumor nucleic acid in peripheral blood to detect or dynamically monitor the patient's condition. Therefore, the quality of free nucleic acid extraction and purification directly affects the reliability of subsequent detection results. Conventional free nucleic acid is purified by lysis column. Although the effect of extraction can meet the requirements of the next step, it cannot meet the requirements of high-throughput detection due to the need for high-speed centrifugation and other operation steps. The issuer adopts the magnetic bead method of nucleic acid extraction technology, which can extract multiple samples at the same time, which can meet the requirements of high-throughput testing. At the same time, the issuer designed and developed special consumables and automatic extraction equipment suitable for free nucleic acid extraction, realizing the automatic extraction of free nucleic acid.

The issuer has built an extraction-free fluorescence PCR technology through self-developed rapid nucleic acid release technology and inhibition-resistant fluorescence PCR technology, which can realize one-step fluorescence PCR on-machine detection. This technology eliminates the cumbersome nucleic acid extraction and purification process, extraction reagents and extraction equipment, and reduces the cost of detection. At the same time, due to fewer operating steps, this technology can significantly reduce the possibility of cross-contamination during sample processing, making the test results more authentic and reliable. In addition, this technology speeds up the detection process, and for large-sample inspection items (such as HPV testing), it increases the daily inspection throughput and greatly improves the detection efficiency.

Conventional fluorescence PCR technology is generally used in the projects detecting 1-3 targets, while projects with more targets require multiple tests, gene chips, or high-throughput sequencing technologies to complete. In response to this problem, based on the multiple fluorescence PCR technology, the issuer independently developed the matrix fluorescence PCR technology. By increasing the dimension of annealing temperature, combined with the fluorescence channel, the detectable flux was doubled. This technology significantly improves the throughput of a single test and meets the needs of clinical large sample projects. Compared with the currently widely used gene chip technology, the operation steps are reduced, and the entire detection process is completed in one step, without opening and transferring, reducing the chance of serious problems such as PCR product contamination. Compared with high-throughput sequencing technology, this technology has shorter detection time, fewer operation steps and lower cost. The technology is simple to operate and easy to master, and has lower requirements for quality controller, and is suitable for more levels of labs. 

The molecular diagnostic system is a fully automated, mainly including sample collection, sample processing (cell concentration, cell disruption), nucleic acid extraction (DNA/RNA separation, etc.), gene amplification, product detection (real-time fluorescence quantification, nucleic acid hybridization, etc.) and other detection processes. With accurate temperature control system often being required and difficulty to achieve manually, sample pretreatment process in molecular diagnosis is complex. Therefore, the molecular diagnosis automation system came into being. It has attracted much attention for its advantages of large flux, good repeatability, high efficiency, closed system anti-pollution, not demanding experimental site requirements and the ability to accurately control temperature and achieve complex pretreatment process.

This technical method combines the annealing temperature (3-4 sites) and the fluorescence channel (3-4 sites) to upgrade the detection throughput to more than 3 times than the one-well detection, reaching 12-16 indicators. This technology significantly improves the throughput of single test and meets the needs of large-scale clinical sample projects. Compared with the currently widely used gene chip technology, it reduces operation steps and completes the entire detection process in one step, eliminating the need for cap opening and transferring, which reduces the probability of serious problems such as PCR product contamination. This technology is simple and easy to master, less requirement for testing personnel and being suitable for more levels of testing departments.