Clinical Laboratory
Overview
The Clinical Laboratory is one of the core departments of SRRSH. Since its establishment, it has brought together the clinical pathology and laboratory technologist and various management elites from Loma Linda University Health in the United States. Over the past 30 years, the Clinical Laboratory has made remarkable achievements in the development of the discipline by combining advanced Western management concepts and testing techniques with its roots in domestic medical practice. The department is unique in the field with its sound organizational structure, reasonable talent structure and high-quality work efficiency. By owning a perfect quality control system, the lab has passed the ISO15189 medical laboratory accreditation. It is the reference laboratory for clinical laboratory testing quality in Zhejiang Province, the quality control center of standardized training of medical laboratory residents in Zhejiang Province, and the Key Laboratory of Precision Medicine in Diagnosis and Monitoring Research of Zhejiang Province. The department is also the unit of the president-designate of the Laboratory Medicine Branch of the Chinese Medical Association, and the current chairman of the Laboratory Medicine Branch of Zhejiang Medical Association. The individualized laboratory diagnosis created by the department has been rated as the medical innovation discipline of Zhejiang Provincial Health Department, has been listed as the 2014 top ten outstanding laboratory departments of Laboratory Medicine in China, and was nominated as the best specialty in Fudan Ranking for many consecutive years.
The department has long been adhering to the service tenet of “Count on Us for Result You Can Trust”, and adhering to the quality policy of “objective and fair, accurate and timely, scientific management, high quality service and continuous improvement”. We strive to provide fast, accurate and reliable test results for the general public and clinicians. “To serve the clinic, to serve the patient” is our own values to pursue forever.
Technical advantages
The Laboratory Department is divided into the clinical hematology laboratory section, clinical biochemistry section, clinical immunology section, clinical microbiology section, molecular diagnosis section, clinical mass spectrometry, blood transfusion section, outpatient and emergency lab, quality control and scientific research and teaching, and other sub-specialties and terms, equipped with domestic and foreign first-class large and medium-sized instruments and equipment, as well as automatic testing lines, to carry out more than 600 test items. In terms of management, the department promotes the development model of “multi-campus integration and services with same standards”, and provides accurate and timely laboratory services and professional reports with complete items for clinical practice. The department has independently developed the LIS system, which won the third prize of the Science and Technology Progress Award of Zhejiang Provincial Government and the Science and Technology Progress Award of Provincial Education Commission in 2003. The system has been promoted and applied to many hospitals both inside and outside the province.
The Mass Spectrometry Lab (Ms Lab) is a key technology platform of SRRSH and an important part of the metabolomics research and development platform of the Key Laboratory of Precision Medicine in Diagnosis and Monitoring Research of Zhejiang Province. At present, it carries out monitoring projects of reproductive hormones, vitamin profiles such as VitA, B, D, E and K, and therapeutic drugs such as antibiotics, immunosuppressants and psychotropic drugs, which play important roles in the diagnosis and treatment of clinically related diseases. The mass spectrometry technology platform has carried out technological innovation in metabolomics research and laboratory-developed method (LDT), and developed metabolic marker models that can be used for the early diagnosis of breast cancer. The department is the first medical institution in China that can detect free testosterone by mass spectrometry. The development of polymyxin B, tigecycline, and other new blood drug concentration detection projects are also in a leading position across the country.
The flow cytometry platform carries out clinical testing projects and scientific research content in the areas of blood disease diagnosis, immune level testing and monitoring, new marker research and development, etc. In addition, it is also an advanced mass spectrometry flow detection platform, providing a high-quality technology platform for domestic instrument research and development, disease immune system level detection and new marker discovery.
The clinical hematology laboratory sector carries out peripheral cell morphology tests, platelet aggregation tests, hemorheology, coagulation function, anticoagulation factor, bone marrow diagnosis of difficult blood diseases, hematopoietic and lymphatic system tumors and other special items. The Bone Marrow Lab is an important part of the clinical examination sector, which makes peripheral blood test, bone marrow cytology diagnosis, and flow cytometry analysis closely integrated and communicated in time, so as to better provide accurate diagnosis for the clinical practice.
The clinical Immunology Laboratory has a variety of technologies such as chemiluminescence immunoassay, enzyme-linked immunoassay, indirect immunofluorescence and so on. It routinely detects antibodies against hepatitis viruses, HIV, syphilis and other pathogens, tumor markers, autoantibodies, endocrine hormones, and drug concentrations. The sector has explored and gradually promoted experience in assay process optimization, immunological quality management, clinical trial design and performance evaluation.
As the center of the “glycated hemoglobin consistency plan” in Zhejiang Province, the clinical biochemical sector has gradually developed an operation system of the intelligent testing process, intelligent quality control, intelligent instrument management, and intelligent sample management. The section continues to carry out a variety of domestic leading projects, including routine biochemistry, reproductive hormones, glycated hemoglobin, serum protein electrophoresis and other indicators to provide accurate and rapid test results for clinics.
The clinical microbiology section not only carries out routine microbial tests, but also provides personalized diagnostic and precision treatment services in the etiological diagnosis of difficult pathogens, multi-drug resistant bacteria combined with anti-infection drug sensitivity test and drug-resistant gene detection. The microbiology sector has participated in a number of international and national pathogenic bacteria epidemiological investigation projects, such as SMART (Study for Monitoring Antimicrobial Resistance Trends), CHINET (China Antimicrobial Surveillance Network) and CARSS (China Antimicrobial Resistance Surveillance System), etc. It has participated in the ECOFF (Epidemiological cut-off values) clinical trials and many antibiotics. It is a participant of ECOFF (Epidemiological cut-off values) clinical trials and establishment of a number of antibiotic epidemiological breakpoints, and has a certain influence at home and abroad.
The molecular section has set the nucleic acid detection of COVID-19 and hepatitis B virus, folic acid metabolism gene (MTHFR) polymorphism detection, and clopidogrel drug metabolism gene (CYP2C19) polymorphism detection. Based on the work of COVID-19 nucleic acid testing, the section organized the drafting of the national group standard “Operating Management Standards for Emergency Nucleic Acid Testing Laboratories” (T/ZCHSP 003-2023).
The Department of Blood Transfusion has actively participated in the clinical perioperative blood management, reasonably various blood components usage, and improved the success rate of rescue of critically ill patients. Through the development and application of platelet-rich plasma (PRP) treatment projects, the department has achieved good clinical results in the treatment of refractory wounds, osteoarthritis, diabetic foot, facial rejuvenation and beauty.
The outpatient and emergency lab carries out a wide range of items, comprehensively and carefully covering the testing needs of routine outpatient and critical care medicine. In addition to the routine items of blood, body fluid and biochemical items, it also carries out the items of morphology, hormones, and lipids, which provide accurate and rapid test results for the clinic. So that “one-stop” services can be truly offered for patients from sample collection onwards.
Academic status
Chairman-designate of the Laboratory Medicine Branch of the Chinese Medical Association
Chairman of the Laboratory Medicine of Zhejiang Medical Association
The core and constructive department of the National Medical Laboratory Research Center
National Training Base for Resident Physicians in Laboratory Medicine
Practical training base of the National Bacterial Drug Resistance Monitoring Network
Zhejiang Provincial Quality Control Centre for the Training of Laboratory Physicians
Talent Training Base of the Clinical Laboratory Diagnosis of Zhejiang University
Zhejiang Provincial Innovative Disciplines--Individualized Testing and Diagnostics Construction Base
Key Laboratory of Precision Medicine in Diagnosis and Monitoring Research of Zhejiang Province
Research achievements
This discipline focuses on infection as well as major chronic diseases such as tumor, respiratory, cardiovascular and metabolic diseases, and screens and validates novel biomarkers through multi-omics technology. In the direction of screening, confirmation and clinical application evaluation of tumor markers, our laboratory reported for the first time that nicotinamide N-methyltransferase (NNMT) is highly expressed in various cancers. Identification of NNMT as a potential therapeutic target for colorectal cancer and breast cancer. NNMT and its metabolic molecules are important markers for predicting the efficacy of tumor chemotherapy, which provides a theoretical basis for the selection of clinical individualized chemotherapy regimens for colorectal cancer and breast cancer. Our department has established an online prediction system for the effective rate, progression-free survival and survival probability of non-small cell lung cancer patients treated with PD-1 monoclonal antibody, and constructed a serum metabolite diagnostic model for breast cancer. The team has won 3 general projects funded by the National Natural Science Foundation of China and 2 key research and development projects funded by the Natural Science Foundation of Zhejiang Province. It won the Third Prize of Scientific and Technological Progress of Zhejiang Province and obtained 1 authorized national patent.
As the main participant, our department wrote the national industry standard of blood sugar, a key monitoring marker in diabetes prevention and control.
With the help of whole genome sequencing technology, our laboratory constructed Multilocus sequence typing (MLST) and its extension scheme (eMLST) for the first time in the world for accurate detection and diagnosis of pathogenic ureaplasma urealyticum (UU), so as to avoid the widespread use of clinical antibiotics and overtreatment. We developed a fluorescence quantitative PCR method for the detection of 14 serotypes of UU. The development of this study provides new clues and research means for exploring the pathogenic mechanism of UU infection, lays a foundation for establishing a new clinical diagnosis technology of pathogenic UU based on virulence factor detection, and provides a scientific basis for the colonization and infection of UU. The subsequent research work won four projects funded by the National Natural Science Foundation and the second prize of the Zhejiang Science and Technology Progress Award.
The department has been responsible for and undertaken more than 30 projects of the National Natural Science Foundation of China and 3 Key Research and Development Projects of Zhejiang Province, published more than 180 SCI papers (highest impact factor of 71.4) and achieved Zhejiang Provincial Science and Technology Progress Awards ( 1 first prize, 3 second prize and 1 third prize ). More than 20 national invention patents have been declared and 7 have been authorized.