In recent years,with increasing investment on laboratory medicine scientific research in China,the project management,implementation,evaluation system and quality improvement become more and more important for research managers and executives.In this paper,the main problems of project execution and implementation and accordingly proposed some constructive suggestions were analysed,in the aspects of the leading role of principal investigator,periodical discussion,peer guidance,scientific progress management,effective using of project funds and the establishment of appropriate reward and punishment mechanisms.It is hoped that these suggestions can be used to achieve success in laboratory medicine research project.

In this paper,the technology development process of morphological analysis was reviewed based on the blood cell analyzers in recent 40 years.The clinical values,advantages and limitations using blood cell analyzer to classify the white blood cell in different development stages were illuminated.It was evident that the manual microscopic examination is still a necessary way for clinical diagnosis,which is not necessarily replaced by the automated clinical analyzers,although some high-precision or high-intelligence machines are helpful for detecting the disease better on various levels.Therefore,it should be adopted in the rational ways for clinical examination based on the evidence-based medicine,and the appropriate diagnosis instruments should be chosen which not only satisfy the needs of clinical diagnosis,but also conform to the national benefit-for-people policies and requirements of healthcare reform.Herein,valuing the morphological examination in clinical diagnosis and strengthening the basic skills trainings should be advocated to improve the qualities and academic levels of clinic examination technicians.

With the rapid development of life science and relevant technology of clinical laboratory medicine,it raised higher demands for current clinical biochemistry,which is to maximize the clinical efficacy and application value under the perfect quality management system.Based on the evidence-based medicine,considering the national conditions and the new situation of medical reform,comprehensive assessment the clinical performance of new technologies and new tests,to provide more objective and reliable evidence for practical application and to guide clinical decision making,is of great significance for the rational allocation and utilization of the limited medical resources.At the same time,promoting the development of personalized medicine process gradually,trying to change the passive medical model,focusing on the disease prediction,prevention and control,taking people as the foremost,optimizing the treatment plan,and strengthening the safety and efficacy of drugs,will become hot topics of clinical biochemistry.

With the rapid advancement of immunology and molecular biology,many new revelations and ideas were drew for clinical immunology in laboratory medicine.In the current circumstances of application of clinical pathway management and individual medical care,how to accurately grasp these changes to build perfect quality system for clinical immunology laboratory,clarify the immunology laboratory pathway and integrate that into clinical pathway management,make solid progress for the promotion and application of individual diagnosis and evaluate the diagnostic value of new technique and item for clinical immunology laboratory accurately might be worth pondering for every people working in clinical immunology laboratory.In this paper,the status quo and reflection of clinical immunology is reviewed.

In present,clinical laboratory is required to continuously improve the quality management system for providing almost perfect reports and services.The new conception and methodology of quality management in clinical laboratory should be constantly updated in order to ensure the patient safety.The article focuses on the integration of risk management and six sigma,into the quality management system for clinical laboratory.

The detection of autoimmune liver disease (AILD) relevant autoantibodies is of important value in the diagnosis and treatment of AILD and especially in autoimmune hepatitis and primary biliary cirrhosis.With the increasing of patients clinically diagnosed AILD,the detection of AILD relevant autoantibodies is gradually clinically concerned and appreciated.As the detection of AILD relevant autoantibodies affected by various factors,there are still many problems in the detection and clinical applications of AILD relevant autoantibodies.We should promote the universal clinical application of AILD relevant autoantibodies,emphasis on the quality management and improve the quality of detection constantly,attend to the standard detection and rational application of AILD relevant autoantibodies.

Liver cancer has a high morbidity and mortality in China.With new technologies and diagnostic instruments being developed,it is a common goal for researchers to discover some new diagnostic biomarkers of high sensitivity and specificity on liver cancer.The clinical laboratory is responsible to choose and understand the diagnosis value of these laboratory indicators and variation in the liver cancer progress.Then,these new biomarkers in screening for early malignancy,aiding cancer diagnosis,determining prognosis can be used effectively in the clinical laboratory to improve laboratory diagnostic capacity in order to serve the clinic more effectively and better.

Despite decades of the prevention and control.China is still one of the countries with high prevalence of hepatitis B virus (HBV).It is imperative for us to innovate.Lab diagnostic platforms for drug-resistant mutation and HBV genotyping to enhance the management level in patients with CHB.Specifically,the following three strategies should be included:firstly,choose an appropriate platform for drug-resistant mutation detection according to the actual situation in laboratory.Secondly,establish a practical and simple genotyping platform for real-time monitoring of HBV genotypes.Thirdly,combined with clinical,explore the correlation among genotypic resistance,phenotypic resistance and clinical resistance when different medications are adopted,confirm the percentage or threshold of resistant strains causing clinical resistance,and ascertain the influence of HBV genome polymorphism (genotype) on clinical prognosis.These strategies above mentioned will lay a foundation for CHB personalized treatment and prognosis.

China is among the middle-high endemic regions of HBV infection.The pathological outcomes of chronic HBV infection have been shown to be greatly influenced by several important factors,including HBV genotype,sub-genotype and gene viability mutation.HBV genome mutation,on the one hand,could alter its replication and secretion and thus change viral pathogenicity.In addition,host immune microenvironment and host-virus interaction,disease progression and the effect of antiviral therapy could be adapted at the same time.The detection of HBV genotypes,genetic subtypes and the key hotspot mutation is helpful to clinical risk assessment and prognosis prediction of HBV-related end-stage liver diseases (cirrhosis and hepatocellular carcinoma),it is also helpful to auxiliary predict the liver diseases recurrence and metastasis after treatment.Thus persistent care should be taken on the HBV mutation and its clinical translation so as to provide solid evidences for the personalized,standardized and fine management of HBV-related liver diseases.

Objective To establish a method for detecting Aspergillus spp.by Loop-mediated isothermal amplification.Methods Aspergillus spp.specific primers were designed from the relative conservation region of the published sequence of 28S rRNA genes of A.fumigatus (GenBank accession number AY660917),A.terreus (GenBank accession number AF454183),A.flavus (GenBank accession number AF454158),and A.niger (GenBank accession number AF454169).Genomic DNA were extracted from Aspergillus standard strains,clinical control strains and clinical samples,and amplified by LAMP.The amplified results could be read with the naked eye by the coloring effect of fluorescent nucleotide dye without the DNA electrophoresis.Approximately 103 each Aspergillus conidia suspension was added to the serum from healthy volunteers,and detected these simulative clinical samples bv LAMP assay.Results The LAMP and PCR assays obtained positive results for all four Aspergillus species and 8 simulative clinical samples (double samples for each Aspergillus species) including 103 conidia,but negative in the remaining 15 non-Aspergillus species,human total blood genomic DNA,30 clinical serum samples infected with non-Aspergillus and 10 healthy volunteers.The LAMP assay had a minimum detection of 0.05-0.5pg,by means of detect different levels of 500,50,5,0.5,0.05 pg template in each reaction tube.Conclusion The results confirm that LAMP is a simple,rapid,sensitive and specific method,and can be used for detection of Aspergillus strains in clinical and environmental specimens.