Human genetic resources refer to human genetic materials such as organs, tissues, cells, nucleic acids, nucleic acid products, etc., containing human genome, genes and their products of the information. China is abundant in human genetic resources, therefore how to protect and make highly rational use of the resources is very critical. In this review we will provide an overview of the current status of the management and utilization of human genetic resources in a global context, and evaluate the status quo of Chinese situation, future challenges and possible solutions.

Klebsiella pneumonia (KP) is a common pathogenic bacteria which can cause infections to the respiratory tract, gastrointestinal tract and urinary tract. The infections usually break out in the neonatal ward, urological ward and tutelary ward. Multi-drug resistant KP strain bring great difficulty to the clinical antibiotic treatment. The present paper mainly discuss the drug resistance mechanism of KP in five aspects including KP β lactam resistance mechanism, the lack of outer membrane protein and the change of the target position, drug resistance mechanism associated with biofilm, drug resistance effects of efflux pump and in tegron. By roundly understanding of the drug resistance mechanism of KP, the rational use of antimicrobial agents and efficient prevention of drug-resistant bacteria may be achieved.

Biological resources are essential for the development and application of life sciences. Biobank is an important foundation and provides resources for biomedical and clinical research to study etiology of diseases, clinical diagnosis and treatment, drug targets discovery, prevention in term of translational research. To standardize collecting, preparing, shipping, storing and retrieving samples are essential to the proper use and sharing of sample resources. It is important to establish a management system that can manage preservation and provision of biological resources in consistent way across biobanks. Sharing samples and associated data are of critical values for biobanks, which would depend on confidence in the capacity and quality of biological resources in the biobanks. The capacity evaluation and validation by a third-party authority is also very important and should serve as one of the major components in the system. The challenges of us facing are lacking a standardized guidance to build biobank, and evaluation system for biobanking management. According to growing demands for the field in China, China National Accreditation Service for Conformity Assessment has conducted aninvestigation on accreditation and standardization of biobanks around the world, which aimed at understanding and learning from the practices and ideas of other countries, promoting the construction of the biobank standardization and evaluation.

With the implementation of hierarchical medical system, the clinical laboratories in the tertiary hospitals have to face new challenges and opportunities. It is necessary to assess strengths, weaknesses, opportunities and threats of the laboratories for actively responding to the call of national policies and for creating an innovative service system combines with the competitive laboratory medical resources, including the equipment, to play a leading role in medical service, technical innovation, quality control, personnel training and so on. A regional laboratory medicine institutions can be established to supply the services to the primary health care and the services of the clinical laboratories in the tertiary hospital can also be extended to both an regional laboratory medicine institutions and the primary health care. It will provide better development path for the clinical medicine according to the hierarchical medical system.

With the rising and developing of translational medicine and precision medicine, the demand for the strategic resource of biobank is increasing day by day. In recent years, biobank has been applied to many fields of biomedical research with expanding scale and diversified types at home and abroad. The improvements of quality control and upgradation of information management guarantee the quality of samples in biobank. This paper describes the international development status of biobank, with a view to contribute to the standardized construction of biobank.

Monitor the quality of clinical specimens and the critical value by using laboratory-hospital information system, finally improve the laboratory quality.

The Taian City Center Hospital clinical and laboratory testing process were further optimized, including returns and defective specimens statistics, automatic review and turnaround time (TAT) statistics and directly reported critical values by LIS-HIS system. A retrospective study were proceed to monitored the quality of clinical specimens and the critical value. One comparison analysis was between 191 719 clinical specimens (from July to December 2013) and 161 308 clinical specimens (from January to June 2014), the rate of unqualified specimen, reason of unqualified specimen and turnaround time was recored. Another comparison analysis was between 5987 critical values (from July to December 2013) and 5082 critical values (from January to June 2014), including blood routine, biochemical examination, blood coagulation experiments, and blood gas.

The monitoring system was established successfully. From January to June 2014, 161 308 clinical specimens were accepted with 1356 send-back and 5082 pushed critical values. After the establishment of the monitoring system, the unqualified rates of specimens dropped from the original 1.31% (2511/191 719) to 0.84% (1356/161 308) significantly (χ²=6.03, P<0.05); the average TAT time of routine blood report reduced from 25.9 min to 18.6 min and the biochemical examination report reduced from 156 min to 72 min significantly (U=12.9, P< 0.01). Meanwhile, the critical value report time dropped from 11.2 min to 7.5 min, critical value reporting consistency increased from 98.8% to 100%, the timeliness of doctor’s disposal in critical values increased from 95.2% to 98.2%.

LIS-HIS system can monitor the laboratory specimens timely and accurately; the automatic review can reduce TAT time, meanwhile the LIS-HIS monitoring critical values can improve the timeliness of clinical disposal. In a word, the system improved the quality and management level of clinical laboratory.

At the beginning of the 2015, US president Obama launched the program of "Precision Medicine". Interpretation of "Precision Medicine" provided better understanding of diseases by combining present structure of medicine and the concept of individualization, leading to the expansion of knowledge through three dimensions: time-space-subject. Recently, gene technology pushed the treatment of cancer forward, gene as well as molecular typing resulted in entirely new comprehension of cancer, and target drug opened a new era of cancer treatment. Until now, however, the overall survival of malignancies (eg. carcinoma of pancreas, liver and lung) remains. "Precision Medicine" brought in revolution of disease classification system, and diagnosis of certain rare or inherited diseases. Huge amount of data were supplied by gene sequencing, which improve the research and application of new drug. With these advances, the clinical application of "Precision Medicine" still confronts numerous challenges, nearly all current guidelines are based on population data rather than personalized characteristics. With the integration of past and present, there is a long way to go for "Precision Medicine".

Progression of tumor depends on angiogenesis in a malignant tissue. Among the numerous endogenous promoters of angiogenesis, vascular endothelial growth factor(VEGF) plays a leading role. VEGF targeted angiogenesis therapy has the remarkable anticancer strategy. So far, there have been many antiangiogenic agents applied in clinic or in clinic trials, including anti VEGF monoclonal antibodies, VEGF receptor kinase inhibitors and small molecular inhibitors targeting on the downstream signal pathways. This review will interpret the VEGF signal system and the status of its targeted treatment. In addition, the mechanism of tumor resistance to antiangiogenic therapy will bee laborated briefly.

Biobank is the key element in translational medicine and precision medicine. The automatic storage system of biobank can guarantee the quality of sample and make operationconvenient, storage efficient, and running cost economic. It is widely applied in the world. The first automatic biobank in China has been established in December 2016 in Shanghai Changzheng Hospital. and is used on managing overall process of sample storage. It can also reliably record complete sample-related electronic information through seamless connect with hospital information system (HIS). Automatic storage system will become the priority-choice of biobank construction. More and more biobank willtransform from manual storage into automatic storage.

Tuberculosis (TB) is a major infectious disease in our country. The untypical clinical manifestation of latent tuberculosis infection and the drug-resistance TB resulted in the serious situation of prevention and control. Early and accurate detection of TB is an effective means to reduce the incidence. With the rapid development of molecular biology and immunology, the time for bacteriology examination and drug sensitive test has been greatly shortened. This review summarizes clinical diagnosis, laboratory diagnosis and development of new diagnosis technology of TB. We hope it could help to improve the sensitivity and specificity of clinical diagnosis, and to determine the unified diagnostic criteria.

To evaluate the analytical performance of endocrine testing using six sigma(σ), and find the cause of dissatisfied performance for some projects combined with the quality goal index (QGI), so that provide rectification direction for the improvement of the endocrine projects quality.

Nine endocrine items which participated in the clinical laboratory external quality assessment (EQA) of the Ministry of Health in 2016 was selected in this study. The two levels of laboratory internal quality control were accumulated in coefficient fo varivation (CV), respectively, as the estimation value. By adopting the quality evaluation standard of the Ministy of public healty the acceptable range of endocrine items was measured as the total allowah error (TEa). CV and Bias with the data of internal quality control (IQC) and EQA was evaluated. The sigma metrics based on the TEa from the National Center for Clinical Laboratory were in accord with the formula σ=(TEa-|Bias|)/CV for each endocrine test. Quality goal index(QGI) was also calculated to investigate the reason for dissatisfied performance as follows: QGI=Bias/(1.5*CV). Evaluate the quality levels of nine endocrine tests with σstatistics. Analyze which improvement measures were needed for each project with QGI.

In low level of IQC, the rates of endocrine items for 4≤σ<5σ, 3≤σ<4, σ<3 were 22.22%, 44.44%, 33.33%, respectively. In high level IQC, the rates of endocrine items for σ≥6, 5≤σ<6, 4≤σ<5, 3≤σ<4, σ<3 were 11.11%, 11.11%, 11.11%, 55.56% and 11.11%, respectively. In the dissatisfied performance of the endocrine tests, which the QGI<0.8 include FT3, FT4, FSH, LH, Prog, Folate, VitB₁₂, which the QGI>1.2 include TSH, T.

Sigma performance verification can be used to evaluate the performance of laboratory testing projects. The sigma and QGI can be used for investigation of the reason for dissatisfied perfarmance of the project, and guiding the improvement of clinical laboratory quality.

In precision medicine. whole genome sequencing data, related molecular information and individual clinical data, are often employed forselecting appropriate and optmal therepiesbased on the contect of a patient′s genetic conten, and then prepare for the development of targeted drugs and achieve accurate medical care. At present, the concept of precision medicine is infiltrating into the fields of clinical tumor diagnosis and treatment. Tumor will be diagnosed and classified according to underlying molecular and related factors to achieve "treating the same disease with different governance" and "treating different diseases with the same protocol". In addition, the next generation sequencing(NGS) technology will be an indispensable technology in precision medicine, which promotes the application of precision medical treatment in the clinical setting. Mereover, it also need to improve the regulatory policies, to achieve the goal of standardized management of NGS in clinical application.

Infectious diseases of obstetrics and gynecology, which are caused by pathogens invading genitourinary tract or other associated parts, often manifests as the reproductive tract inflammation or systemic infectious diseases. Due to their specificity, the diseases can cause infertility, ectopic pregnancy, fetal demise, premature birth, stillbirth, congenital infection and neonatal infections. These outcomes mentioned here may affect the health of the two generations if the diseases are not timely diagnosed and proper treated. Some severe cases may lead to concurrent cancer or AIDS. The World Health Organization has long been committed to the research of laboratory examination and standard techniques of the infectious diseases of obstetrics and gynecology to prevent and control the spread of such diseases.

Despite the significant advancement in vaccine, influenza continues to be a threaten to public health. Influenza has caused serious morbidities and mortalities both during yearly seasonal epidemics and historic pandemics. Early and accurate laboratory diagnosis to influenza virus is critical for initiation of antiviral therapy with neuraminidase inhibitors and for control of the infection. We discuss currently available approaches of laboratory diagnosis for influenza, in which viral culture, antigen detections, nucleic acid amplification tests and serology are included.

How to apply information management system to track and manage entire workflow-driven procedure of sample collection, processing, storage and distribution, and how to characterize biological samples with associated information, are two imperative components of best operation and management in a biobank. Moving from concept to practice, biobanking in China has survived several challenges when researchers first realized the quality of stored samples could have great impact on the quality of research, followed by facing the challenge that banked samples have limited usability. That is the third issue since samples lack annotation with associated information from clinical and other resources. This issue challenges scientists to determine if samples are appropriate for answering a given scientific questions. It turns out to be a waste of time and money by banking large accumulation of samples if the issues are not solved. Sample holds little value itself without associated clinical and other information. It is only a transit form before the biological data reflecting health or disease status can be extracted throughout multiple ways. By following the biomarkers and related indicators in samples, scientists can discover the dynamic changing set from health to disease, followed by recovery after treatment or medical intervention. It is an important role and aim of a biobank to maximize the value of biological samples. To do so, it is essential to fully utilize banked samples appropriately to extract the value it holds. It is a must to know samples in term of biological sense. Therefore, quality, annotation and usability become three key elements in term of effective and efficient values of a biobank. In summary, information management and sample annotation would be the key to the quality and valuable resources for research.

The study was to determine plasma myeloperoxidase (MPO), oxidized low density lipoprotein (OX-LDL) and lipoprotein-associated phospholipase A2 (LP-PLA2) levels in Beijing healthy adults and investigate the correlation among these three biomarkers and risk factors of cardiovascular disease.

One thousand one hundred and fifty-five healthy subjects, including 567 male and 588 female, were selected from Center of Health Examination of Armed Police General Hospital during the period of February to October 2015, who range in age from 18 to 87. Plasma MPO, OX-LDL and LP-PLA2 levels were determined by enzyme linked immunosorbent assay (ELISA). Groups were set by gender and age according to C28-A2 standard of Clinical and Laboratory Standards Institute (CLSI) and series of guiding principles of performance evaluation in vitro diagnostic reagent. Male and female subjects were classified into four subgroups by age respectively as those who were from 18 to 29,≥30 to 39,≥40 to 49,≥50. The correlation among levels of MPO, OX-LDL and LP-PLA2 was achieved by regression analysis method.

One thousand one hundred and fifty-five healthy subjects of MPO reference value was 94.1 μg/L, while OX-LDL and LP-PLA2 reference range were 14.08-127.58 mg/L and 47.30-218.96 μg/L respectively. Experimental results showed that these three biomarkers in plasma of healthy subjects increased with the growing age. Male and female did not need to set up independent subgroups of reference range, but there was significant difference in plasma OX-LDL and LP-PLA2 between male and female (t value were 2.134, 2.381; P< 0.05), while there was no statistically significant difference in plasma MPO (Z =1.641, P>0.05); Meanwhile, there was significant correlation among MPO, OX-LDL and LP-PLA2 (r value were 0.181, 0.174, 0.470; P<0.01).

Reference ranges of plasma MPO, LP-PLA2 and Ox-LDL have been set up for Beijing healthy adults, which can be used clinically as biomarkers of cardiovascular disease.

Diagnoses of hematolymphoid malignancies result from multidisciplinary participation and comprehensive analyses; this includes clinical data, imaging studies, pathology and various esoteric tests. For the last twenty years, because of advances in tumor biology, various novel modalities of anti-cancer treatments especially with targeted anti-cancer drugs, and new technology, classification of hematolymphoid malignancies has become more and more complex; at the same time, the diagnoses and treatment modalities have been trending towards greater sophistication and precision. In addition to the initial diagnosis, nowadays, a modern pathology and laboratory service center must have abilities to provide multiple tests of increasing sensitivity and complexity for the purposes of, for example, prognosis and risk stratification, targeted therapy, treatment effect monitoring, disease monitoring after remission, target gene mutation monitoring, prognosis reassessment after chemotherapy, and treatment re-adjustment. Therefore, pathology and laboratory service have become an imperative component of modern medicine. Morphology alone or using any single test simply cannot meet the hematology-oncology needs. In fact, multi-test modalities, comprehensive analyses and integrated reporting, are standard practice along with their training programs throughout the health systems in the North America. At the turn of the century, technologies including immunohistochemistry, flow cytometry, cytogenetics, and later, molecular diagnostics have been adopted for the diagnoses of hematolymphoid malignancies in China. This article further discusses comprehensive approaches to the diagnoses of hematolymphoid malignancies, their organizational structures, and multidiscipline-oriented subspecialty training programs for hematopathologists. The approaches are characterized by emphasizing that hematopathologists must have comprehensive subspecialty-required multidiscipline analytical skill, must have abilities to provide integrated diagnoses based on the disease classification or comprehensive clinical-relevant interpretation of multi-test results, rather than provide technical results only, and must deliver integrated hematopathology reports.

Thrombelastography (TEG) is a whole blood test, which is from the beginning of blood coagulation, to the formation of blood clots and the whole process of fibrin dissolution, which is widely used in clinical practice. Compared with the traditional method of coagulation testing, TEG is more close to the physiological state, and reflect the whole picture of the coagulation of patients more authentic and accurate. This paper focuses on the principle of TEG in a comprehensive analysis of the coagulation/fibrinolysis status of patients with thrombosis and hemorrhagic diseases, its clinical significance in patients with the timing of surgery, monitoring of anticoagulation factors, bleeding reason analysis, the use of blood products. Disseminated intravascular coagulation (DIC) and venous thromboembolism risk assessment, etc. The analysis will help clinicians to access timely and effective information, and to take reasonable treatment measures for patients with thrombosis and hemorrhagic disease.