International Standard for Medical Laboratories Accreditation demanded monitoring the quality of the total testing process (TFP).Recently, the errors in the analysis phase had been effectively controlled, while the errors in pre-and post-analytical phases still remained comparably high, and became the major factors influencing the TTP quality.Thus, monitoring and improving the quality of the extraanalytical phases became the major challenge.Monitoring the TTP quality required the laboratory staff to extend the quality management to the influential elements outside the laboratory.In addition, it also prompted the organizers of external quality assessment (EQA) in China to provide a quality assurance program for extra-analytical phases.The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) had developed a model of quality indicators.The Q-Probes and Q-Tracks programs of the College of American Pathologists provided a good practice of monitoring and improving quality for the extraanalytical phases.Based on the related international guidelines, the QIs system was established for quality management and control in clinical laboratory, so as to manage EQA of extra-analytical phases.

BACKGROUND: Cigarette smoking has been recognized as one of the high risk factors in carcinogenesis of lung cancer. Early diagnosis of lung cancer may be of clinical therapy value.OBJECTIVE: To explore the mutation of K-ras oncogene in bronchoalveolar lavage fluid(BALF) in order to reveal its relationship with cigarette smoking in lung cancer patients.DESIGN: Randomized controlled trial based on the patients.SETTING: Department of Toxicology, College of Radiology and Public Health of a university, and Department of Respiratory Medicine of a university hospital.PARTICIPANTS: The out-patients and inpatients in the Second Affiliated Hospital of Soochow University between June 1999 and September 2001 were included. The patients were confirmed to have lung cancer or innocuous diseases by fiber bronchoscopy through bronchoalveolar lavage(BAL) and cytological or pathological examination.METHODS: BALF samples were obtained from 37 smoking patients with lung cancer and 25 nonsmoking patients with lung cancer, and 20 with benign pulmonary diseases in the Second Affiliated Hospital of Soochow University. They were detected for K-ras codon 12 mutations using polymerase chain reaction with restriction fragment length polymorphism(PCR-RFLP).MAIN OUTCOME MEASURES: Codon 12 mutations of K-ras gene.RESULTS: K-ras mutation in patients with lung cancer was found to have an average frequency of 36% (22/62)but no K-ras gene mutation was detected in patients with benign pulmonary diseases. The mutation frequency in heavy smokers(69% ) was higher than that in moderate smokers(31%), mild smokers (25%) and nonsmokers (20%). The mutation was related to age and history of smoking, but not to sex and TNM classification.CONCLUSION: Cigarette smoking may be correlated with the mutation of K-ras gene. Early detection of K-ras mutation in BALF may be of clinical value, which helps the identification and diagnosis of smoking-related lung cancer.

In type 2 diabetes mellitus,the levels of leptin were higher in female and obese subjects compared with male and non-obese subjects.There was negative relationship in female between leptin and HbA_1c,and negative relationship between leptin and HDL-C in male.Gender and obesity had no effect on TNF-? and NP Y.

Objective To investigate endoscropic assist in rat orotracheal intubation.Methods 40 rats were randomly divided into two groups.The procedure time, total time, intubation frequency,the success rate of the first intubation and the survival rate in 24h were compared between the conventional group and the endoscropic group.Results The total time in two groups were nearly the same.But the procedure time and frequency of intubation were significantly less in the endoscropic group than those in the conventional group.The success rate of the first intubation in the endoscropic group was obviously higher than that of the conventional group.There was no obviously difference between the survival rate after extubation in 24h between groups.Conclusion Endoscropic assist is superior to the conventional method and worth promoting.

Objective To observe the impact of DPP4 inhibitor Saxagliptin on body weight of type 2 diabetes patients. Methods In this randomized and parallel study,50 patients were given either Saxagliptin(n=25)or Glimepiride(n=24). The changes of body weight, HbA1c and hypoglycemic events were observated in 12 weeks. Results There were no significant difference in gender,age and body weight between 2 groups(P>0. 05). After 12 weeks treatment,body weight has significant changed in both group,and the weight changes were sig-nificant differet in two groups:an average of 0. 4 kg weight was increased in Glimepiride group and 0. 4 kg weight was decreased in Saxagliptin group (P<0. 05). The change of HbA1c level has no statistical difference in two groups (P>0. 05). Hypoglycemia event was happened four times in Glimepiride group,while no hypoglycemia event was happened in Saxagliptin group. Conclusion Compared with Glimepiride,Saxa-gliptin provides similar hypoglycemic action with less hypoglycemia,at the same time,Saxagliptin yields better results in lowering weight.

Objective To investigate the relationship between the leptin level and neonatal weight and the expression of leptin in placenta. Methods The concentrations of leptin in 100 maternal blood and umbilical blood of the term pregnant women were examined by radioimmunoassay (RIA). According to the neonatal weight to divide into the large for gestational age (LGA) group 19 cases, the appropriate for gestational age (AGA) group 65 cases, the small for gestational age (SGA) 16 cases. The level of leptin mRNA in 41 placental tissue was examined by Reverse transcription polymerase chain reaction (RT PCR). Results (1) The expression level of leptin mRNA in placenta was 0 97?0 04, which was positively related to the neonatal weight significantly ( r =0 43, P 0 05).(3)The concentration of leptin in umbilical blood was (7 58? 5 15) ?g/L, which was positively related to the neonatal weight ( r =0 57, P

With the advantage of clear target and little side effect, antibody drug has attracted widely attention of worldwide pharmaceutical companies. However, large scale mammalian cell culture and antibody quality analysis are the bottlenecks of antibody drug industrialization in China. Especially due to the significant effect of cell culture conditions on antibody heterogeneity. Therefore, it is extremely urgent to optimize cell culture conditions to favor the demands of antibody drug development. This review summarized the most recent advances in the effect of cell culture conditions on antibody quality, followed by addressing the key issues that might be strategically important for domestic antibody drug development.
Animals ; Antibodies, Monoclonal ; biosynthesis ; isolation & purification ; Antibody Formation ; Cell Culture Techniques ; methods ; trends ; Genetic Heterogeneity ; Protein Stability ; Quality Control

ObjectiveTo study HIV-1 DNA levels in different parts of HIV patients during the early stage of antiretroviral therapy.MethodsThe peripheral blood,gut associated lymphoid tissues and lymph nodes samples were collected before and 12 weeks after treatment in regular follow-up HIV-1/AIDS patients in Beijing Youan Hospital ( n =11 ).The average age was 39 years old ( 25 to 55 ).Mononuclear Cells were isolated by density gradient centrifugation and then used DNA extraction kit to extract DNA.Realtime quantitative polymerase chain reaction was used to examine HIV-1 DNA copy-number.Non-parametric test was used to analyse the differences of HIV-1 DNA copy numbers among groups.Results Before treatment,HIV-1 DNA copy-number in both gut associated lymphoid tissues ( 10 714 ± 2043 ) copies/106 cells and lymph nodes (9145 ± 1202) copies/106 cells were higher than that in the peripheral blood (66 ± 8) copies/106 cells ( U =0.00,P ＜0.05 ),There was no significant difference between lymph nodes and gut associated lymphoid tissues (U =46.00,P ＞0.05).After 12 weeks of treatment,HIV-1 DNA copy-number in both gut associated lymphoid tissues (1701 ± 790) copies/106 cells and lymph node (11 591 ± 1781 ) copies/106 cells were higher than the peripheral blood ( 18 ± 3 ) copies/106 cells ( Z =- 2.934,P ＜ 0.05 ).There was a significant reduction of DNA copy-number in gut associated lymphoid tissues and peripheral blood after treatment (Z =- 2.934,P ＜ 0.05 ).Conclusion Gut associated lymphoid tissues and lymph nodes may be important latent reservoirs for HIV-1 DNA.

BACKGROUND: There are different methods to isolate and culture human nucleus pulposus cells, and the differences in digestive enzymes components and digestion time quite are significant. So how to rapidly and efficiently harvest human nucleus pulposus cells has become a research hotspot. OBJECTIVE: To optimize the digestive enzymes components and digestion methods for the preparation of human nucleus pulposus cells. METHODS: Nucleus pulposus tissue specimens were selected from three adult discs in the Department of Orthopedics, China-Japan Union Hospital of Jilin University. The acute traumatic disc tissues that outstanding to the spinal canal were taken under aseptic conditions, and then the peripheral white annulus and jel y-like nucleus pulposus in the center could be seen. According to different mixed enzyme concentration ratio, the samples were divided into two groups. The enzyme Ⅰ group was treated with 0.2% Ⅱ col agenase; and the mixed enzymeⅡ group was digested with 0.25% trypsin for 30 minutes, and then treated with 0.2% Ⅱ col agenase. According to digestion time, each group was divided into three subgroups: 2 hours group, 4 hours group, and overnight group. Final y, suspended cel volume was decided as 2 mL to count cells. Dulbecco’s modified Eagle’s medium containing fetal bovine serum was used for cel culture in vitro. Trypan blue staining was performed to count total cel number and ratio of living cells. Methylthiazolyldiphenyl-tetrazolium bromide assay was used to detect the growth curve of nucleus pulposus cells. RESULTS AND CONCLUSION: Based on the two digestion enzyme concentration, the number of digested cells in the enzyme Ⅰ group was larger than that in the enzyme Ⅱ group after digested for 2 and 4 hours, but the difference was not significant (P > 0.05). Overnight, cellsurvival rate was decreased in the enzyme Ⅰ group after digested for 2 and 4 hours when compared with the enzyme Ⅱ group, and the difference was significant (P < 0.05). After digested for 4 hours, tissue blocks disappeared, and the number of cells reached maximum. The results indicate that enzyme Ⅰgroup composite with Ⅱ col agenase is benefit for the separation of nucleus pulposus cells, and the digestion time is appropriate to 4 hours. This condition has the advantages of simple operation, high efficiency and low cost, and it considered that digestion of nucleus pulposus tissues with 0.2% Ⅱ col agenase for 4 hours is the best condition to obtain nucleus pulposus cells.

BACKGROUND:Advancement in bioengineering based upon tissue engineering techniques may offer the possibility of repairing degenerative intervertebral disc.
OBJECTIVE:To summarize the research progress in the scaffolds of tissue engineered intervertebral disc.
METHODS:A computer-based retrieval was performed to search manuscripts describing tissue engineered intervertebral disc scaffolds published between January 1st, 1900 and December 31st, 2012 in PubMed database with the key words of“tissue engineering, intervertebral disc, scaffold”in English.
RESULTS AND CONCLUSION:Scaffold is an important part of tissue-engineered research. There are three kinds of materials for intervertebral disc scaffolds:natural biomaterials, synthetic materials, and composite materials. A variety of scaffold materials have their own advantages and disadvantages. Up to now, none of these scaffold materials is accepted as the most suitable one. The selection of scaffold materials is stil to be further studied. The study and development of nanoscale biomaterials is an inevitable trend. Otherwise, with the help of bionics, improving scaffolds is also an inexorable trend in progress of simulating human intervertebral disc. Furthermore, injectable scaffold is also an research hot spot, and the selection range of injectable scaffold materials mainly focuses on chitosan, typeⅡcolagen,hyaluronic acid,fibrin,elastin,and alginate.C urrently, studies on chitosan as a scaffold material are relatively more.