Medicina di laboratorio

The Laboratory Medicine Department is one of the core departments of Sir Run Run Shaw Hospital. Since the hospital was founded, it has brought together laboratory medicine and pathology experts from Loma Linda University Medical Center in the United States, as well as management professionals in various fields. Over the past 30 years, the department has integrated advanced Western management concepts and laboratory technologies with domestic medical practice and has achieved remarkable results in discipline development. With a sound organizational structure, a rational talent structure, and high-quality, efficient work, the department stands out in its field. The department has a comprehensive quality-control system and has passed ISO 15189 medical laboratory accreditation. It is the reference laboratory for clinical laboratory quality in Zhejiang Province, the Quality Control Center for Standardized Residency Training in Medical Laboratory Departments of Zhejiang Province, and the Key Laboratory of Medical Precision Testing and Monitoring Research of Zhejiang Province. It is also the institution where the President-elect of the Laboratory Physicians Branch of the Chinese Medical Doctor Association and the current Chairperson of the Laboratory Medicine Branch of the Zhejiang Medical Association are based. The Individualized Laboratory Diagnostics discipline established by the department was recognized as a medical innovation discipline by the Zhejiang Provincial Health Department, was shortlisted among China’s Top Ten Outstanding Laboratory Medicine Departments for 2014, and has been nominated for the Best Specialty in the Fudan Rankings for many consecutive years.

The department has long adhered to the service mission of “Count On Us for Result You Can Trust” and followed the quality policy of “objectivity and impartiality, accuracy and timeliness, scientific management, quality service, and continuous improvement.” It responds to patients’ urgent needs and anticipates clinical needs, takes patients as the center and employees as the principal participants, and strives to provide the general public and clinical physicians with laboratory results that are rapid, accurate, and trustworthy. “Serving clinical practice and serving those seeking medical care” is the intrinsic value that we will always pursue.

Technical Strengths

The Laboratory Medicine Department is divided into multiple subspecialties and teams, including clinical laboratory testing, biochemistry, immunology, microbiology, molecular diagnostics, mass spectrometry, transfusion medicine, the outpatient and emergency laboratory, quality control, and research and teaching. It is equipped with first-class large- and medium-sized laboratory instruments and equipment and automated testing lines from China and abroad, and conducts more than 600 laboratory test items. In terms of management, the department promotes a development model of “integration across multiple campuses and services of consistent quality,” providing clinical departments with accurate and timely laboratory services, a comprehensive range of testing items, and professional reports. The Laboratory Medicine Department independently developed an LIS system, which received the Third Prize of the Zhejiang Provincial Government Science and Technology Progress Award and the Science and Technology Progress Award of the Zhejiang Provincial Education Commission in 2003, and was subsequently promoted and applied in many hospitals inside and outside Zhejiang Province.

The Mass Spectrometry Laboratory is a key technical platform developed by Sir Run Run Shaw Hospital and an important component of the metabolomics research and development platform of the Key Laboratory of Medical Precision Testing and Monitoring Research of Zhejiang Province. It currently conducts testing projects for reproductive hormones; vitamin profiles including VitA, VitB, VitD, VitE, and VitK; and therapeutic drug monitoring projects for antibiotics, immunosuppressants, psychotropic drugs, and other therapeutic drugs. It plays an important role in the diagnosis and treatment of clinically relevant diseases. The mass spectrometry technology platform carries out technological innovation in metabolomics research and laboratory-developed tests (LDTs), and has developed a metabolic biomarker model that can be used for the early diagnosis of breast cancer. It became the first medical institution in China capable of detecting free testosterone by mass spectrometry. It has also developed new blood drug concentration testing projects for polymyxin B, tigecycline, and several other drugs, which are at the national leading level.

The flow cytometry technology platform conducts clinical testing projects and research in the diagnosis of hematological diseases, testing and monitoring of immune levels, and development of new markers. In addition, the platform is equipped with an advanced mass cytometry testing platform, providing a high-quality technical platform for the development of domestically produced instruments, testing of the immune-system status of diseases, and discovery of new markers.

The Clinical Laboratory conducts specialized testing projects including peripheral blood cell morphology testing, platelet aggregation tests, hemorheology, coagulation function, anticoagulant factors, bone marrow diagnosis of difficult hematological diseases, and tests related to tumors of the hematopoietic and lymphatic systems. As the Bone Marrow Laboratory is an important component of the Clinical Laboratory, peripheral blood testing, bone marrow cell diagnosis, and flow cytometric analysis can be closely integrated and communicated in a timely manner, thereby enabling the department to provide more precise diagnoses for clinical practice.

The Immunology Laboratory currently has multiple technology platforms, including chemiluminescent immunoassay, enzyme-linked immunoassay, and indirect immunofluorescence. It routinely conducts tests for antibodies against pathogens such as hepatitis viruses, human immunodeficiency virus, and Treponema pallidum, as well as tumor markers, autoantibodies, endocrine hormones, drug concentrations, and other items. It has carried out in-depth exploration in the optimization of testing procedures, immunology quality management, clinical trial design, and performance evaluation, and has gradually promoted its experience in these areas.

As the center of Zhejiang Province’s “Glycated Hemoglobin Consistency Program,” the Biochemistry Laboratory has gradually established an operational system featuring intelligent testing procedures, intelligent quality control, intelligent instrument management, and intelligent sample management. It continuously conducts various nationally leading projects, including testing projects for routine biochemical indicators, reproductive hormones, glycated hemoglobin, serum protein electrophoresis, and other indicators, providing clinical departments with accurate and rapid test results.

The Microbiology Laboratory conducts not only routine microbiology testing projects but also provides individualized diagnostic and precision treatment services in the etiological diagnosis of difficult pathogens, combined antimicrobial susceptibility testing for multidrug-resistant bacteria, and resistance gene testing. The Microbiology Laboratory has participated in a number of international and domestic pathogen epidemiological investigation projects, including SMART (Study for Monitoring Antimicrobial Resistance Trends), CHINET (China Antimicrobial Surveillance Network, China Bacterial Resistance Surveillance Network), and CARSS (China Antimicrobialresistance Surveillance System, National Bacterial Resistance Surveillance Network). It is a participating institution in domestic ECOFF (Epidemiological cut-off values) clinical trials and in the development of epidemiological breakpoints for multiple antibiotics, and has a certain influence both domestically and internationally.

The Molecular Laboratory offers novel coronavirus nucleic acid testing, hepatitis B virus nucleic acid testing, folate metabolism gene (MTHFR) polymorphism testing, and clopidogrel drug-metabolism gene (CYP2C19) polymorphism testing. Based on its work in novel coronavirus nucleic acid testing, the department organized and drafted the national group standard Specification for the Operation and Management of Emergency Nucleic Acid Testing Laboratories (T/ZCHSP 003-2023).

During its development, the Transfusion Department has actively participated in perioperative patient blood management, rationally used various blood components, and improved the success rate of rescue for critically ill patients. Through the development and application of platelet-rich plasma (PRP) treatment programs, the department has achieved good clinical results in the treatment of difficult-to-heal wounds, osteoarthritis, diabetic foot, facial rejuvenation and cosmetic procedures, and other conditions.

The Outpatient and Emergency Laboratory offers a wide range of testing projects, comprehensively and meticulously covering the testing needs of routine outpatient services and the Department of Critical Care Medicine. In addition to routine blood, body-fluid, and biochemical tests, it also conducts morphological, hormonal, blood-lipid, and other tests, providing clinical departments with accurate and rapid test results and truly meeting patients’ need for a “one-stop” service in which, beginning with sample collection, they need to make fewer trips or no trips at all.

Academic Standing

Institution of the President-elect of the Laboratory Physicians Branch of the Chinese Medical Doctor Association

Institution of the Chairperson of the Laboratory Medicine Branch of the Zhejiang Medical Association

Construction institution for a core unit of the National Clinical Medical Research Center for Medical Laboratory

National Standardized Residency Training Base for Laboratory Medicine

Practical Training Base of the National Bacterial Resistance Surveillance Network

Zhejiang Provincial Quality Control Center for Standardized Training of Laboratory Physicians

Talent Training Base for the Discipline of Clinical Laboratory Diagnostics at Zhejiang University

Construction Base for the Zhejiang Innovative Discipline—Individualized Laboratory Diagnostics

Key Laboratory of Medical Precision Testing and Monitoring Research of Zhejiang Province

Research Achievements

This discipline focuses on major chronic diseases involving infection and tumors, respiratory diseases, and cardiovascular and metabolic diseases. Through the screening and validation of new biomarkers using multi-omics technologies, in the areas of tumor-marker screening, confirmation, and clinical application assessment, this laboratory was the first internationally to report the high expression of nicotinamide-N-methyltransferase (NNMT) in multiple tumors; established that NNMT is a potential therapeutic target for colorectal cancer and breast cancer; and established that NNMT and its metabolic molecules are important biomarkers for predicting the efficacy of tumor chemotherapy. These findings provide a theoretical basis for the selection of individualized clinical chemotherapy regimens for colorectal cancer and breast cancer. The department established an online prediction system for treatment response rates, disease-progression-free probabilities, and survival probabilities in patients with non-small cell lung cancer receiving anti-PD-1 monoclonal antibody treatment; constructed a diagnostic model based on serum metabolites in breast cancer; obtained three General Program projects of the National Natural Science Foundation of China and two key research and development projects of Zhejiang Province; received the Third Prize of the Zhejiang Provincial Science and Technology Progress Award; and obtained one granted national patent. As a principal participating institution, the department helped draft the national industry standard concerning blood glucose, a key monitoring marker in diabetes prevention and control.

Using whole-genome sequencing technology, this laboratory was the first internationally to develop a Multilocus sequence typing (MLST) scheme and its extended scheme (eMLST) for Ureaplasma urealyticum, for the precise detection and diagnosis of pathogenic Ureaplasma urealyticum, thereby avoiding the widespread clinical use of antimicrobial drugs and overtreatment. We developed a fluorescence quantitative PCR method for detecting 14 serotypes of Ureaplasma urealyticum. This research provided new clues and research tools for exploring the pathogenic mechanisms of Ureaplasma urealyticum infection, laid the foundation for establishing a new clinical diagnostic technology for pathogenic Ureaplasma urealyticum based on virulence-factor detection, and provided a scientific basis for distinguishing Ureaplasma urealyticum colonization from infection. Subsequent research work received four General Program projects of the National Natural Science Foundation of China and the Second Prize of the Zhejiang Provincial Science and Technology Progress Award.

Focusing on its research directions, the department has led and undertaken more than 30 projects funded by the National Natural Science Foundation of China and three projects under the Zhejiang Provincial Key Research and Development Program. It has published more than 180 SCI papers, with a highest impact factor of 71.4; received one First Prize, three Second Prizes, and one Third Prize of the Zhejiang Provincial Science and Technology Progress Award; and applied for more than 20 national invention patents, of which seven have been granted.