As the advanced technology of proteomics, the surface-enhanced laser desorption/ionization Time-of-Flight Mass Spectrometry(SELDI-TOF-MS)has great potential in clinical application for it′s technological features.Whether it can be applied in clinical trials depends on the quality control and standardization of the technology.In the article, we introduced and discussed the following aspects of the issue.1) quality controlling before sample being analyzed, including the collection and preparation of samples, the selection and conservation of reagents, the calibration and attendance of laboratory apparatus;2) quality controlling during the assay, that is, the validation and analysis of the experimental result;3) the standardization of the continued data handling and analyzing, including the standardization of the analyzed data′s nature, the selection and standardization of the data′s analyzing methods, the system evaluation of the whole SELDI-TOF-MS technological system.

OBJECTIVE To study the application value of protein chip technique in detection of Helicobacter pylori(Hp) infection and clinical diagnosis of associated disease. METHODS The antibodies against CagA,Ure and VacA in 300 serum samples were detected by protein chip technique.The biopsy specimens obtained by gastroscopy from 170 patients with digestive system symptom were detected by modified Giemsa staining at the same time.These patients were also accepted with rapid urease test(RUT) and ~(14)C-urease breath test (~(14)C-UBT).Twenty serum samples from Hp infected patients were detected again after treatment. RESULTS The sensitivity of protein chip technique in detection of Hp infection was 92.5%,the specificity was 41.3%,the total consistent rate was 73.5%,the positive predictive value was 72.8%,and the negative one was 76.5%.The disease was serious in CagA~+ Hp.The antibody′s concentration was lower after treatment in patients infected Hp. CONCLUSIONS The method of protein chip for Hp infection detection could be used in judging the type of Hp.It is suitable for guiding of medicine and the monitoring of treatment.

Objective The automated capillary zone electrophoresis (CE) is used for human serum protein analysis and compared with the results of agarose gel electrophoresis (AGE) for human serum protein analysis.Discuss its′ practical application in clinical.Methods With the Capillarys ?1-?2+reagent set, proteins in serum were separated at 7 kV for 4 min in 15.5 cm?25.0 ?m fused-silica capillaries (n=8) at 35.5℃ in a pH 10 buffer with online detection 200 nm.Results Capillary zone electrophoresis compared with agarose gel electrophoresis(AGE;Hydrasys-Hyry; Hydragel protein(e)15/30/54 reagent set;Sebia)in precision, relatives, linearity and potential interferences were analyzed.A samples without Para-protein (n=165) were performed relation test. The coefficient of relation between CE and AGE is 0.929 for albumin, 0.924 for for ?1-globulin, 0.841 for ?2-globulin, 0.789 for ?-globulin, 0.926 for ?-globulin. There was no significant difference (P

Objective: To study the vaccine potency of gene-modified tumor cells, we have constructed IL-12, H7-1 and GM-CSF express vector using retrovirus. Methods: It was transfected into EL-4 thymic lylmphoma cells respectively and the effect of gene transduction on anti-tumor immunity were investigated. Results: The tumorigenicity of EL-4/IL-12 transfectant in C57BI/6 syn- ergistical mice was decreased significantly after implanted with EL-4/IL-12 transfectant compaired with EL-4/Wt or EL-4/Neo groups (P

In order to study the vaccine potency of gene-modified tumor cells, IL-12 express vector was constructed by using retrovirus. The vector was transfected into EL-4 thymic lymphoma cells and the effect of transfectant on anti-tumor immunity was investigated. The tumorigenicity of EL-4/IL-12 transfectant in syngeneic C57BL/6 mice was decreased significantly after implanted with EL-4/IL-12 transfectant compared with EL-4/Wt or EL-4/Neo groups (P < 0.001). The systemic protective immunity was induced against the challenge with EL-4/Wt (in 8/10 mice) after the rejection of EL-4/IL-12 in vivo experiment, a stronger CTL activity against EL-4/Wt cells and a weak killer activity against syngeneic Lewis lung carcinoma (LLC) cells were obtained in (51)Cr release assay. In vivo depletion analysis suggested that the decreased tumorigenicity mainly depended on CD4(+), CD8(+) and NK cells. Therapeutic vaccines with EL-4/IL-12 cells could retard the growth of established EL-4/Wt tumors significantly compared with those of EL-4/Neo (P < 0.005). These studies suggested that immunotherapy and gene therapy using IL-12 is effective in hematopoietic malignancy and IL-12 has prospects of application in human cancer treatment in the near future.

Objective:To investigate the expression level of serum ficolin-3 (FCN3) in breast cancer patients and its relationship with prognosis.Methods:A total of 145 patients with breast cancer (the breast cancer group) who were treated in Boao Evergrande International Hospital from February 2014 to February 2016 and 148 healthy women during the same period (the healthy control group) were selected. The level of FCN3 was detected by using enzyme-linked immunosorbent assay (ELISA); the serum carbohydrate antigen 153 (CA153) level of the two groups was detected by using automatic electrochemiluminescence immunoassay; the diagnostic value of serum FCN3 for breast cancer was evaluated by using receiver operating characteristic curve (ROC). The relationship between the level of serum FCN3 and the clinicopathological characteristics of breast cancer patients was analyzed. Kaplan-Meier method was used to analyze and compare the 3-year overall survival rate of breast cancer patients with different serum FCN3 levels.Results:Serum FCN3 level in breast cancer group was (14.1±3.4) μg/ml, which was higher than that in the healthy control group [(9.1±3.0) μg/ml], and the difference was statistically significant ( t = 13.644, P < 0.01). The serum CA153 level in breast cancer group was (36.3±15.2) U/ml, which was higher than that in the healthy control group [(16.8±6.9) U/ml], and the difference was statistically significant ( t = 14.397, P < 0.01). The area under the curve (AUC) of serum FCN3 and CA153 for the diagnosis of breast cancer was 0.894 and 0.720, respectively. The AUC of combined detection of serum FCN3 and CA153 for the diagnosis of breast cancer was 0.909, which was higher than that of CA153 alone ( Z = 2.050, P = 0.040), but compared with FCN3 alone, the difference was not statistically significant ( Z = 0.157, P = 0.875). Serum FCN3 level in stage Ⅲ breast cancer patients was higher than that in stage Ⅰ and Ⅱ patients, and serum FCN3 level in stage Ⅱ patients was higher than that in stage Ⅰ patients (all P < 0.05). The breast cancer patients with lymph node metastasis had higher serum FCN3 level compared with those patients without lymph node metastasis ( P < 0.05). The 3-year overall survival rate of breast cancer patients in the low-level FCN3 group (≤12.07 μg/ml) was higher than that in the high-level group (>12.07 μg/ml) ( P = 0.033). Conclusion:Serum FCN3 is up-regulated in breast cancer patients, which is expected to be a potential index for diagnosis and prognosis evaluation of breast cancer.

Objective To compare and study the two kinds of quality control methodologies related to intelligent quality management system ( iQM) and traditional quality control , and the quality control performance of iQM equivalent to traditional quality control were evaluated , ensuring the accuracy of the results of blood gas testing.Methods Beijing Chaoyang Hospital of Capital Medical University , Beijing Tiantan Hospital of Capital Medical University , Shanghai Longhua Hospital of Shanghai University of Chinese Medicine, and Sichuan Provincial People′s Hospital, these 4 medical institutions were selected to implement this study.During the period from June 2016 to December 2016, in the routine detection of total 3 712 specimen, the iQM and traditional quality control modes were used simultaneously to calculate the mean values of all blood gas parameters quality controls , SD, CV (%) and Sigma values, to evaluate the quality control performance and difference of the two quality control modes .Results During the process of testing blood gas samples from 3 712 specimen in 4 hospitals, iQM process control solution ( PCS) A, B, C ran 1 089, 7 678 and 154 quality control samples respectively , and 732 external quality control samples were run by traditional quality control mode .Considering the most sensitive parameters of blood gas testing pO 2, iQM PCS A, B, C′s Sigma value are higher than 8, however, the traditional quality control′s Sigma value are less than 6; For parameters pCO2, pO2and Na+, there exists significant difference between two quality control methods (P＝0.004 8,P＝0.000 1,P＝0.004 4,P＜0.01), other parameters pH, K+, Ca ++, Glu, Lac and Hct, there exists no significant difference between two quality control methods (P＝0.250 6, P＝0.062 3,P＝0.034 0,P＝0.346 9,P＝0.186 3,P＝0.823 1,P＞0.01).Totally 22 errors detected by iQM, includes 14 micro-clots and 8 interferences samples, which were not detected by traditional quality control .Conclusions The error in blood gas analysis mainly comes from the pre-analytical phase.iQM enhanced specimen inspection capabilities and make up for the inability of traditional quality control to monitor the quality of specimens , enabling full-scale, real-time, and dynamic monitoring of each specimen , powerful error detection capabilities , and automatic error correction capabilities . Besides, automatic documentation saves staff much time.The system can effectively ensure the accuracy of blood gas test results, meet the quality requirements of related laws and regulations and related industry standards , and also can meet the clinical intended use , providing new ideas for POCT quality management and improvement.