Mass spectrometry diagnostics are more sensitive, specific, and accurate than conventional diagnostic technologies, and they have the added benefits of high throughput, high efficiency, and cheap cost. Mass spectrometry technology can systematically and accurately detect dozens or even hundreds of biomarkers in a single diagnosis and can detect a variety of biomarkers that cannot be detected by conventional diagnostic technology, such as hormone small molecular markers, etc. In clinical tests, it can be utilized for biochemical, immunological, microbiological, and molecular biological diagnostics. It is essential for microbial identification, neonatal disease screening, vitamin detection, etc. In addition to clinical application, mass spectrometry is widely used in DNA and protein analysis, drug metabolic toxicity analysis, and drug dosage form design and development because of its high specificity, selectivity, sensitivity, sample pretreatment technology, and chromatographic separation technology.

Under the tenet of precision medicine, the demand for omics detection is a significant factor in the advancement of mass spectrometry. As the currently prevalent PCR technology can only detect a single index at a time, and the information acquired is insufficient, clinicians are unable to make accurate clinical judgments using precision medicine. The second-generation sequencing technology is complex, expensive, involves an overly long cycle, and has a degree of excessive diagnosis and treatment, making it difficult to adapt to the policy of controlling medical insurance. Consequently, the development of precision medicine is still restricted to first-tier cities such as Beijing, Shanghai, Guangzhou, and Shenzhen, and it is difficult to penetrate. Mass spectrometry can quantify and analyze thousands of proteins and bioactive metabolites in tissues, body fluids, or cell cultures simultaneously, and can be used for comprehensive or targeted quantification down to ultra-trace levels to build fine genomics, transcriptomics, proteomics, lipidomics, and metabolomics profiles, providing the basis for big data to enable precision medicine, drug development, testing, and diagnostics.

Article 53 of the newly revised Regulation for the Supervision and Administration of Medical Devices in China emphasizes that if in vitro diagnostic reagents of the same type are not yet available in China, eligible medical institutions may develop and use these reagents in their own units to meet clinical needs. If the LDT system is fully implemented in China, it will facilitate the development of clinical laboratories and various analyte-specific reagents (ASR), promote the personalization of diagnostic products, and thus open the application space for mass spectrometry in various detection fields of precision medicine such as concomitant diagnosis and other precision medicine. At present, clinical mass spectrometry in China is still dominated by microbial testing, vitamin testing, and newborn screening. However, LDT is important for personalized clinical diagnosis and special tests, which is not present in the layout of in vitro diagnostic reagent manufacturers due to the scarcity of patients (such as rare diseases). LDT can fully meet clinical needs with low cost and high efficiency, making it possible for mass spectrometry to be utilized in clinical testing in more diverse fields.