Laboratory Medicine

The Department of Laboratory Medicine is one of the core departments of Sir Run Run Shaw Hospital. Since the hospital was founded, it has brought together laboratory pathology experts and various management professionals from Loma Linda University Medical Center in the United States. Over the past 30 years, the department has combined advanced Western management concepts and laboratory testing technologies with domestic medical practice, achieving remarkable results in discipline development. With a sound organizational structure, a rational talent structure, and high-quality work efficiency, the department stands out among its peers. The department has a comprehensive quality-control system and has passed ISO15189 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 in Zhejiang Province, and the Key Laboratory of Medical Precision Testing and Monitoring Research of Zhejiang Province. It is also the institution of the president-elect of the Laboratory Physicians Branch of the Chinese Medical Doctor Association and the incumbent chairperson of the Laboratory Medicine Branch of the Zhejiang Medical Association. The individualized laboratory diagnosis established by the department was recognized as a medical innovation discipline by the Zhejiang Provincial Department of Health, was shortlisted among the Top Ten Outstanding Laboratory Departments in China in 2014, and has been nominated for Best Specialty in the Fudan Rankings for many consecutive years.

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

Technical Advantages

The Department of Laboratory Medicine is divided into multiple subspecialties and teams, including clinical laboratory testing, biochemistry, immunology, microbiology, molecular testing, mass spectrometry, transfusion, outpatient and emergency laboratories, quality control, and research and teaching. It is equipped with first-rate large- and medium-sized laboratory instruments and equipment from China and abroad, as well as automated testing lines, and conducts more than 600 laboratory test items. In terms of management, the department promotes a development model of “integration across multiple campuses and consistent-quality services,” providing clinical practice with accurate and timely laboratory services, a comprehensive range of test items, and professional reports. The department independently developed a 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 Provincial Education Commission in 2003, and was subsequently promoted and applied in many hospitals inside and outside the province.

The Mass Spectrometry Laboratory is a key technical platform prioritized for development 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, B, D, E, and K; and therapeutic drug monitoring of antibiotics, immunosuppressants, psychotropic drugs, and others, playing 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. The new blood drug concentration testing projects it developed, including polymyxin B and tigecycline, are also at the leading level nationwide.

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

The Clinical Laboratory conducts specialized testing projects including peripheral blood cell morphology testing, platelet aggregation testing, hemorheology, coagulation function, anticoagulant factors, bone marrow diagnosis of difficult hematologic diseases, and testing related to neoplasms of the hematopoietic and lymphoid systems. Because the Bone Marrow Laboratory is an important component of the Clinical Laboratory, peripheral blood testing, bone marrow cell diagnosis, and flow cytometric analysis are closely integrated and communicated in a timely manner, thereby providing more precise diagnoses for clinical practice.

The Immunology Laboratory currently has multiple technology platforms, including chemiluminescence immunoassay, enzyme-linked immunoassay, and indirect immunofluorescence. It routinely conducts testing 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 conducted in-depth exploration and gradually disseminated its experience in testing-process optimization, immunological quality management, clinical trial design, and performance evaluation.

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

The Microbiology Laboratory not only conducts routine microbiological testing projects, but also provides individualized diagnostic and precision-treatment services in the etiological diagnosis of difficult pathogens, combined antimicrobial susceptibility testing of multidrug-resistant bacteria, and antimicrobial-resistance gene testing. The Microbiology Laboratory has participated in multiple 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 establishment 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 the department’s experience in novel coronavirus nucleic acid testing, the department organized the drafting of the national group standard “Specifications 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 the perioperative blood management of clinical patients, rationally used various blood components, and improved the rescue success rate of critically ill patients. Through the implementation and application of platelet-rich plasma (PRP) treatment projects, the department has achieved good clinical results in the treatment of hard-to-heal wounds, osteoarthritis, diabetic foot, facial rejuvenation and cosmetic procedures, and other conditions.

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

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

Designated institution for the construction of a core unit of the National Clinical Research Center for Medical Laboratory Medicine

National Standardized Residency Training Base in Laboratory Medicine

Practical Training Base of the National Bacterial Resistance Surveillance Network

Zhejiang Provincial Quality Control Center for Standardized Training of Laboratory Physicians

Zhejiang University Talent Training Base for Clinical Laboratory Diagnostics

Construction Base for the Zhejiang Provincial Innovative Discipline—Individualized Laboratory Diagnosis

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

Research Achievements

This discipline focuses on major chronic diseases such as infections and tumors, respiratory diseases, and cardiovascular and metabolic diseases. Through the screening and validation of novel biomarkers using multi-omics technologies, and in the area of tumor biomarker screening, confirmation, and clinical application evaluation, this laboratory was the first to report that nicotinamide-N-methyltransferase (NNMT) is highly expressed in multiple tumors. It established that NNMT is a potential therapeutic target for colorectal cancer and breast cancer, and further established that NNMT and its metabolic molecules are important biomarkers for predicting the efficacy of tumor chemotherapy, providing a theoretical basis for the selection of individualized clinical chemotherapy regimens for colorectal cancer and breast cancer. This department created an online predictive system for the treatment response rate, progression-free survival, and survival probability of patients with non-small-cell lung cancer receiving anti-PD-1 monoclonal antibody treatment, constructed a diagnostic model based on breast cancer serum metabolites, 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 unit, our department drafted the national industry standard for blood glucose, a key monitoring biomarker in diabetes prevention and control.

With the aid of whole-genome sequencing technology, this laboratory was the first internationally to construct a multilocus sequence typing (MLST) scheme for Ureaplasma urealyticum and its extended scheme (eMLST), for the precise detection and diagnosis of pathogenic Ureaplasma urealyticum, thereby avoiding the widespread clinical use of antimicrobial drugs and overtreatment. We developed fluorescent quantitative PCR detection methods for 14 serotypes of Ureaplasma urealyticum. This research provides new clues and research approaches for exploring the pathogenic mechanisms of Ureaplasma urealyticum infection, lays the foundation for establishing a new clinical diagnostic technology for pathogenic Ureaplasma urealyticum based on virulence-factor detection, and provides 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.

Around its research directions, the department has led and undertaken more than 30 projects of the National Natural Science Foundation of China and three key research and development programs of Zhejiang Province; 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.