Anhui Medical University Licenses Tryptophan Metabolite Detection Patent for RMB 500,000 to Anhui Haibote Medical Technology

Professor Liu Zhicheng, the principal inventor of the patent, is an Associate Professor at the School of Pharmacy, Anhui Medical University. His research focuses on clinical metabolomics, primarily involving the prognosis, treatment, and intervention of diseases such as sepsis and diabetes. He has published five academic papers in international journals, including *Critical Care*, *Analytical & Bioanalytical Chemistry*, and *Life Sciences*.

Tryptophan (TRP) metabolism is closely associated with various diseases, including sepsis and diabetes. As a highly heterogeneous condition, sepsis poses significant challenges in diagnosis, treatment, and prognostic assessment. Studies have shown that the onset and progression of sepsis are intimately linked to dynamic changes in the gut microbiota. Dysbiosis of the gut microbiome is highly correlated with sepsis-induced organ dysfunction, and TRP along with its metabolites plays a crucial role in the pathogenesis and development of sepsis.

Although high-performance liquid chromatography–tandem mass spectrometry (HPLC‑MS/MS) offers high sensitivity and resolution, enabling the identification of tryptophan (TRP) and its metabolites in biological samples, its widespread application is limited by high costs and the specialized expertise required for data analysis.

To thoroughly investigate the metabolic levels of tryptophan (TRP) and its metabolites in sepsis, and to elucidate the associations between these metabolites and the onset, progression, and gut microbiota dysbiosis of sepsis, Professor Liu Zhicheng’s team first pretreated serum samples using reagents containing internal standards. The processed samples were then analyzed by high-performance liquid chromatography with a diode array detector (HPLC-DAD). Using this approach, they obtained chromatographic peak area data and performed normalization with internal standards, thereby accurately determining the relative contents of tryptophan and its metabolites.

It is understood that the HPLC-DAD method can rapidly and effectively analyze nine key TPR metabolites in sepsis patients within a single chromatographic run. This method not only simplifies the pretreatment process of serum samples but also achieves rapid relative quantification of multiple TPR metabolites. With its advantages of simplicity, speed, and stability, the HPLC-DAD method provides robust guidance for the clinical diagnosis and treatment of sepsis.

Compared with traditional testing techniques such as biochemistry and immunoassays, clinical chromatography-mass spectrometry demonstrates significant advantages in sensitivity, specificity, and multiplexed detection. It not only serves as an effective complement to biochemical and immunological methods but also represents an expansion and deepening of traditional testing technologies. Today, this technology is playing an increasingly important role in various clinical areas, including newborn screening for inherited metabolic disorders, vitamin testing, therapeutic drug monitoring, hormone assays, microbial identification, pharmacogenomic analysis, and trace element detection.

Currently, domestic companies are making frequent moves on technical platforms such as liquid chromatography-tandem mass spectrometry (LC-MS/MS), microbial mass spectrometry, nucleic acid mass spectrometry, and inductively coupled plasma mass spectrometry (ICP-MS). Meanwhile, multiple innovative enterprises are actively establishing their presence in the point-of-care testing (POCT) adaptation, automation, and innovative application areas of mass spectrometry instruments.

First, regarding point-of-care testing (POCT) adaptation, given the high cost, bulky size, and complex operational procedures of traditional mass spectrometers, the industry has begun developing POCT devices as the clinical value of mass spectrometry technology becomes increasingly prominent. POCT-adapted mass spectrometers, characterized by their rapid analysis, portability, compact design, and ease of use, demonstrate broad application prospects in real-time analysis. These devices can detect volatile organic compounds (VOCs) and non-volatile organic compounds, making them suitable for bedside monitoring in intensive care units (ICUs) and clinical departments, such as anesthesia monitoring in operating rooms.

Among them, Jingzhi Future has developed a compact point-of-care testing (POCT) breath analysis device using MEMS microfluidic technology. This device is compact, easy to operate, non-invasive, and offers rapid detection times, making it suitable for early cancer screening and diagnosis, detection of infectious diseases, diagnosis in critical care medicine, and personal health management for chronic diseases. Meanwhile, Qingpu Technology has launched a range of portable mass spectrometers, including the Cell Micro Mass Spectrometry Analysis System and the Mini β Compact Mass Spectrometry Analysis System, providing rapid mass spectrometry solutions for disease screening, POCT, and personalized medical research. These solutions cover technologies such as qualitative detection and rapid screening of five antidepressants, including amitriptyline, in urine, and quantitative detection of imatinib in blood.

On the other hand, the automation of clinical chromatography-mass spectrometry technologies is also a key area for corporate strategic deployment. Although mass spectrometry analysis and data processing after sample loading are not complex, the cumbersome sample pretreatment process has become a bottleneck restricting improvements in testing efficiency. To address this issue, several domestic companies have launched fully automated sample pretreatment platforms.

For example, Baichen Medical has developed the iMS-2000 automated immuno-mass spectrometry pre-processing platform. Based on the principle of specific antibody-antigen binding, this platform enables automated, high-throughput enrichment of target analytes. By combining this capability with the high sensitivity and specificity of mass spectrometry detection, it achieves standardization and automation in clinical mass spectrometry testing. Meanwhile, Biotech has established the IntelliQM automated pre-processing workstation, which addresses the need for automated sample preparation during nucleic acid genotyping and protein quantification. It supports flexible switching between 96-well and 384-well formats and meets the pre-processing requirements for both high-abundance and low-abundance protein biomarkers.

As more innovative enterprises join the field and new technologies continue to emerge, clinical mass spectrometry will continue to play a vital role in the future, providing more precise and efficient testing methods for clinical diagnosis and treatment.