Objective To detect Serum metabolites with label-free surface-enhanced Raman spectroscopy(SERS)for quickly distinguishing the metabolic profiles of breast cancer patients and healthy subjects.Methods A kind of Plasma nano-material was synthesized as a probe for SERS,which has also been used to detect Raman reporter mol-ecules to assess its detection capability.Serum samples from breast cancer patients and healthy subjects were col-lected and the proteins were precipitated with methanol and removed to collect serum metabolites.Probe-based SERS was used to analyze the serum metabolites of patients and explore the changes in the metabolic profiles of breast cancer patients.Results The SERS probe was synthesized and validated.An analytical method based on SERS probe was established,which achieved a linear range(LR)of 4 orders of magnitude and a limit of detection(LOD)up to 10 nmol/L.Raman spectra of serum metabolites from 5 breast cancer patients and 5 healthy subjects were analyzed to study differences in metabolite changes.Conclusions In this study,the molecular spectrum differences of serum metabolites in breast cancer patients were screened by probe-based SERS method,which pro-vides a technology support research on the metabolic changes caused by breast cancer so potentially provide a new method for fast breast cancer screening.

【Objective】 To objectively evaluate the quality control level of blood testing process in blood banks through quantitative monitoring and trend analysis, and to promote the homogenization level and standardized management of blood testing laboratories in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation service, blood component preparation, blood testing, blood supply and quality control was established. The questionnaire Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong province. Quality monitoring indicators of each blood bank from January to December 2022 were collected, and 31 indicators in terms of blood testing were analyzed using SPSS25.0 software. 【Results】 The proportion of unqualified serological tests in 17 blood bank laboratories was 55.84% for ALT, 13.63% for HBsAg, 5.08% for anti HCV, 5.62% for anti HIV, 18.18% for anti TP, and 1.65% for other factors (mainly sample quality). The detection unqualified rate and median were (1.23±0.57)% and 1.11%, respectively. The ALT unqualified rate and median were (0.74±0.53)% and 0.60%, respectively. The detection unqualified rate was positively correlated with ALT unqualified rate (r=0.974, P<0.05). The unqualified rate of HBsAg, anti HCV, anti HIV and anti TP was (0.15±0.09)%, (0.05±0.04)%, (0.06±0.03)% and (0.20±0.05)% respectively. The average unqualified rate, average hemolysis rate, average insufficient volume rate and the abnormal hematocrit rate of samples in 17 blood bank laboratories was 0.21‰, 0.08‰, 0.01‰ and 0.02‰ respectively. There were differences in the retest concordance rates of four HBsAg, anti HCV and anti HIV reagents, and three anti TP reagents among 17 blood bank laboratories (P<0.05). The usage rate of ELISA reagents was (114.56±3.30)%, the outage rate of ELISA was (10.23±7.05) ‰, and the out of range rate of ELISA was (0.90±1.17) ‰. There was no correlation between the out of range rate, outrage rate and usage rate (all P>0.05), while the outrage rate was positively correlated with the usage rate (r=0.592, P<0.05). A total of 443 HBV DNA positive samples were detected in all blood banks, with an unqualified rate of 3.78/10 000; 15 HCV RNA positive samples were detected, with an unqualified rate of 0.13/10 000; 5 HIV RNA positive samples were detected, with an unqualified rate of 0.04/10 000. The unqualified rate of NAT was (0.72±0.04)‰, the single NAT reaction rate [(0.39±0.02)‰] was positively correlated with the single HBV DNA reaction rate [ (0.36±0.02) ‰] (r=0.886, P<0.05). There was a difference in the discriminated reactive rate by individual NAT among three blood bank laboratories (C, F, H) (P<0.05). The median resolution rate of 17 blood station laboratories by minipool test was 36.36%, the median rate of invalid batch of NAT was 0.67%, and the median rate of invalid result of NAT was 0.07‰. The consistency rate of ELISA dual reagent detection results was (99.63±0.24)%, and the median length of equipment failure was 14 days. The error rate of blood type testing in blood collection department was 0.14‰. 【Conclusion】 The quality monitoring indicator system for blood testing process in Shandong can monitor potential risks before, during and after the experiment, and has good applicability, feasibility, and effectiveness, and can facilitate the continuous improvement of laboratory quality control level. The application of blood testing quality monitoring indicators will promote the homogenization and standardization of blood quality management in Shandong, and lay the foundation for future comprehensive evaluations of blood banks.

【Objective】 To establish an effective quality monitoring indicator system for blood quality control in blood banks, in order to analyze the quality control indicators for blood collection and supply, and evaluate blood quality control process, thus promoting continuous improvement and standardizing management of blood quality control in blood banks. 【Methods】 A quality monitoring indicator system covering the whole process of blood collection and supply, including blood donation services, component preparation, blood testing, blood supply and quality control was established. The Questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process was distributed to 17 blood banks in Shandong, which clarified the definition and calculation formula of indicators. The quality monitoring indicator data from January to December 2022 in each blood bank were collected, and 20 quality control indicators data were analyzed by SPSS25.0 software. 【Results】 The average pass rate of key equipment monitoring, environment monitoring, key material monitoring, and blood testing item monitoring of 17 blood banks were 99.47%, 99.51%, 99.95% and 98.99%, respectively. Significant difference was noticed in the pass rate of environment monitoring among blood banks of varied scales(P<0.05), and the Pearson correlation coefficient (r) between the total number of blood quality testing items and the total amount of blood component preparation was 0.645 (P<0.05). The average discarding rates of blood testing or non-blood testing were 1.14% and 3.36% respectively, showing significant difference among blood banks of varied scales (P<0.05). The average discarding rate of lipemic blood was 3.07%, which had a positive correlation with the discarding rate of non testing (r=0.981 3, P<0.05). There was a statistically significant difference in the discarding rate of lipemic blood between blood banks with lipemic blood control measures and those without (P<0.05). The average discarding rate of abnormal color, non-standard volume, blood bag damage, hemolysis, blood protein precipitation and blood clotting were 0.20%, 0.14%, 0.06%, 0.06%, 0.02% and 0.02% respectively, showing statistically significant differences among large, medium and small blood banks(P<0.05).The average discarding rates of expired blood, other factors, confidential unit exclusion and unqualified samples were 0.02%, 0.05%, 0.003% and 0.004%, respectively. The discarding rate of blood with air bubbles was 0.015%, while that of blood with foreign body and unqualified label were 0. 【Conclusion】 The quality control indicator system of blood banks in Shandong can monitor weak points in process management, with good applicability, feasibility, and effectiveness. It is conducive to evaluate different blood banks, continuously improve the quality control level of blood collection and supply, promote the homogenization and standardization of blood quality management, and lay the foundation for comprehensive evaluation of blood banks in Shandong.

【Objective】 To establish an effective quality indicator monitoring system, scientifically and objectively evaluate the quality management level of blood banks, and achieve continuous improvement of quality management in blood bank. 【Methods】 A quality monitoring indicator system that covers the whole process of blood collection and supply was established, the questionnaire of Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong. Statistical analysis of 21 quality monitoring indicators in terms of blood donation service (10 indicators), blood component preparation (7 indicators ), and blood supply (4 indicators) from each blood bank from January to December 2022 were conducted using SPSS25.0 software The differences in quality monitoring indicators of blood banks of different scales were analyzed. 【Results】 The average values of quality monitoring indicators for blood donation service process of 17 blood banks were as follows: 44.66% (2 233/5 000) of regular donors proportion, 0.22% (11/50) of adverse reactions incidence, 0.46% (23/5 000) of non-standard whole blood collection rate, 0.052% (13/25 000) of missed HBsAg screening rate, 99.42% (4 971/5 000) of first, puncture successful rate, 86.49% (173/200) of double platelet collection rate, 66.50% (133/200) of 400 mL whole blood collection rate, 99.25% (397/400) of donor satisfaction rate, 82.68% (2 067/2 500) of use rate of whole blood collection bags with bypass system with sample tube, and 1 case of occupational exposure in blood collection.There was a strong positive correlation between the proportion of regular blood donors and the collection rate of 400 mL whole blood (P<0.05). The platelet collection rate, incidence of adverse reactions to blood donation, and non-standard whole blood collection rate in large blood banks were significantly lower than those in medium and small blood banks (P<0.05). The average quality monitoring indicators for blood component preparation process of 17 blood banks were as follows: the leakage rate of blood component preparation bags was 0.03% (3/10 000), the discarding rate of lipemic blood was 3.05% (61/2 000), the discarding rate of hemolysis blood was 0.13%(13/10 000). 0.06 case had labeling errors, 8 bags had blood catheter leaks, 2.76 bags had blood puncture/connection leaks, and 0.59 cases had non-conforming consumables. The discarding rate of hemolysis blood of large blood banks was significantly lower than that of medium and small blood banks (P<0.05), and the discarding rate of lipemic blood of large and medium blood banks was significantly lower than that of small blood banks (P<0.05). The average values of quality monitoring indicators for blood supply process of 17 blood banks were as follows: the discarding rate of expired blood was 0.023% (23/100 000), the leakage rate during storage and distribution was of 0.009%(9/100 000), the discarding rate of returned blood was 0.106% (53/50 000), the service satisfaction of hospitals was 99.16% (2 479/2 500). The leakage rate of blood components during storage and distribution was statistically different with that of blood component preparation bags between different blood banks (P<0.05). There were statistically significant differences in the proportion of regular blood donors, incidence of adverse reactions, non-standard whole blood collection rate, 400 mL whole blood collection rate, double platelet collection rate, the blood bag leakage rate during preparation process, the blood components leakage rate during storage and distribution as well as the discarding rate of lipemic blood, hemolysis blood, expired blood and returned blood among large, medium and small blood banks (all P<0.05). 【Conclusion】 The establishment of a quality monitoring indicator system for blood donation services, blood component preparation and blood supply processes in Shandong has good applicability, feasibility and effectiveness. It can objectively evaluate the quality management level, facilitate the continuous improvement of the quality management system, promote the homogenization of blood management in the province and lay the foundation for future comprehensive evaluation of blood banks.

Objective: To explore the association between the 21-gene recurrence score (RS) and clinicopathologic characteristics as well as prognosis in patients with axillary lymph node negative, hormone receptor (HR) positive breast cancer. Methods: The clinicopathologic data of 439 early breast cancer patients who underwent 21 gene RS testing was retrospectively analyzed. According to the 21 gene RS, the patients were divided into low risk (295 cases), intermediate risk (111 cases) and high-risk (33 cases) group. The relationship between the 21 gene RS and clinicopathological characteristics, treatment, recurrence and metastasis was analyzed. Univariate and multivariate statistical analyses were used to analyze the risk factors for relapse free survival (RFS). Results: Tumor grade, estrogen receptor (ER), progesterone receptor (PR) and Ki-67 index were significantly different among the 3 risk cohorts (P<0.001 for all). After a median follow-up of 32 months, the recurrence rate in low risk group (3.7%) was significantly lower than that in the intermediate-high risk group (9.0%), the locoregional recurrence (LRR) rate of low, intermediate and high risk group was 2.4%, 6.3% and 9.1%; and the distant metastasis (DM) rate in low risk group was 1.4% and 2.1% in the intermediate-high risk group. Univariate analysis showed RS, ER status and endocrine therapy were prognostic factors for RFS (P<0.05 for all). Multivariate analysis showed that RS was an independent significant predictor for RFS (P=0.04). Conclusions The 21-gene RS is related to tumor grade, ER, PR and Ki-67 index. RS is an independent risk factor for RFS in patients with hormone receptor positive early-stage breast cancer.

Objective: To establish comprehensive laboratory reference intervals for Chinese children. Methods: This was a cross-sectional multicenter study. From June 2013 to December 2014, eligible healthy children aged from 6-month to 17-year were enrolled from 20 medical centers with informed consent. They were assessed by physical examination, questionnaire survey and abdominal ultrasound for eligibility. Fasting blood samples were collected and delivered to central laboratory. Measurements of 15 clinical laboratory parameters were performed, including estradiol (E2), testosterone(T), luteinizing hormone(LH), follicle-stimulating hormone(FSH), alanine transaminase(ALT), serum creatinine(Scr), cystatin C, immunoglobulin A(IgA), immunoglobulin G(IgG), immunoglobulin M(IgM), complement (C3, C4), alkaline phosphatase(ALP), uric acid(UA) and creatine kinase(CK). Reference intervals were established according to central 95% confidence intervals for reference population, stratified by age and sex. Results: In total, 2 259 children were enrolled. Finally, 1 648 children were eligible for this study, including 830 boys and 818 girls, at a mean age of 7.4 years. Age- and sex- specific reference intervals have been established for the parameters. Reference intervals of sex hormones increased gradually with age. Concentrations of ALT, cystatin C, ALP and CK were higher in children under 2 years old. Serum levels of sex hormones, creatinine, immunoglobin, CK, ALP and urea increased rapidly in adolescence, with significant sex difference. In addition, reference intervals were variable depending on assay methods. Concentrations of ALT detected by reagents with pyridoxal 5'-phosphate(PLP) were higher than those detected by reagents without PLP. Compared with enzymatic method, Jaffe assay always got higher results of serum creatinine, especially in children younger than 9 years old. Conclusion This study established age- and sex- specific reference intervals, for 15 clinical laboratory parameters based on defined healthy children.

Objective To explore the safety and cosmetic effect of nipple-sparing modified radical mas tectomy and immediate tissue expander implantation with single circumaereolar incision.Methods 30 patients were enrolled in Peking Union Medical College Hospital between Jan.2014 and Dec.2015.All the patients were categorized according to surgical incision (single circumaereolar incision group vs double incisions group).Data on clinicopathological parameters,average hospital stay,complications and overall cosmetic effect were retrospectively collected.Data was performed with Chi-square test,Fisher exact test and t-test.Statistical significance was defined as P＜0.05.Results 19 patients were enrolled in single circumaereolar incision group,and 11 patients in double incisions group.There was no significant difference for operation duration (P=0.093) and average hospital stay (P=0.339).After follow-up for 19.1 months,ranging from 8 to 31 months,no patients developed seroma or arm lymphedema.There was no statistical significance between the two groups in terms of sensation in nippleaereolar area (P=0.973),bilateral symmetry (P=0.650) and overall cosmesis (P=0.483).Conclusion single circumaereolar incision nipple-sparing modified radical mastectomy and immediate tissue expander implantation can be one of the preferable surgical procedures with benefits of minimal invasiveness,reliable oncological safety and decent cosmetic effect.

Objective To analyze the species classification and chracteristics of drug resistance and virulence in CTX-M producing Escherichia coli isolated from urine culture.Methods Escherichia coli cultured by urine were collected from our hospital during 2014,the ring disk diffusion test was implemented to determine the bacterial susceptibility,the EBLs determination test was used to analyze the bacterial EBLs producing situation;the enterobactoer duplicated gene spacer consensus sequency PCR(ERIC-PCR) was adopted to perform the genetic relation analysis;PCR was used to amplify the CTX-M encoding genes and multiple virulence genes iutA,ompT,fyuA,fdeC,fimH,traT,cvaC,pap,kpsMT,pAI,usp,aer,hlyA,cnf and chuA;the multiple PCR was used to analyze the species calssification of CTX-M-producing Escherichia coli;these strains of bacteria were classified as the CTX-M-producing group and non-CTX-M-producing group according to the results of CTX-M coding gene detection,the differences in the antibacterial drug resistance and virulence genes between the two gorups were performed the contrastive analysis.Results One hundred and sixty-two strains of E.coli by urine culture had no genetic correlation,among 126 EBLs positive strains,91 strains produced CT-M,in which 57 strains of CT-M producing Escherichia coli belonged to type D,and 116 strains belong to Type B2.The statistical analysis found that the drug resistance rate in the CTX-M-producing group was significantly higher than that in the non-CT-M producing group (except for imipenem),the prevalence of virulence genes including iutA,chuA and traT in the CT-M producing bacteria group was significantly higher than that in the non-CTX-M-producing group(P=0.001,0.006,0.000)Conclusion CTX-M-producing E.coli is main pathogenic bacterium of urinary infection in our hospital,its majority belong to type D with increased drug resistance,moreover has close correlation with virulence genes iutA,chuA and traA and is a pertential threat in clinical treatment of urinary infection.

Objective To analyze the susceptibilities of Escherichia coli isolates collected from blood and the prevalence of ESBLs encoding genes.Methods A total of 121 Escherichia coli isolates collected from blood during 2012 were analyzed for antimicrobial susceptibilities by software of WHONET 5.6,the production of ESBLs was confirmed by confirmatory pheno-typic testing,PCR and DNA sequence were further implemented to analyze the ESBLs-encoding genes.Results 121 E.coli isolates displayed high resistance towards broad spectrum penicillin and 2nd or 3rd generation cephalosporins,levofloxacin and cotrimoxazole,with the resistance rates being more than 40%,susceptibilities to imipenem,piperacillin/tazobactam,ami-kacin were observed,with the resistance rates to be less than 12%,86(88.7%)out of 121 isolates were found to produce ESBLs.Among them,59.5% (72),38.8% (47)and 4.1% (5)were confirmed to carry blaCTX-M,blaTEM and blaSHV genes.Additionally,2(1.7%)isolates carried all the genes detected,30(24.8%)isolates carried both of blaCTX and bla-TEM,1(0.8%)isolate carried both of blaSHV andblaTEM.Conclusion Most of the E.coli isolates from the blood culture in Nanjing Gulou Hospital produce ESBLs,and displayed resistance towards most of the penicillins,cephalosporins and sin-gle amide antimicrobial agents should be chosen according to susceptibility results.

Objective To evaluate the effect of oxidative injury induced by peroxide oxidase on Klotho expression in mouse renal tubular epithelial cells (TCMK-1) and to explore the possible pathway.Methods TCMK-1 cells were exposed to H2O2 of different concentrations.Reactive oxygen species (ROS) was examined byflow cytometrry.Cell viability was assessed by CCK-8.Cell apoptosis was evaluated by flow cytometry and Hoechst 33258 staining.The expression of Klotho,apoptosis-associated proteins and anti-oxidant enzymes were determined by Western blotting.Results Compared with control group,after H2O2 stimulating TCMK-1 cell,ROS was dramatically elevated (all P ＜ 0.05) and the expression of anti-oxidant enzymes,SOD2 and CAT went down (all P ＜ 0.05);the expression of Klotho was inhibited (all P ＜ 0.05);cell viability of TCMK-1 cells was decreased (all P ＜ 0.05) in a dose-dependent manner (0.3 to 0.9 mmol/L);cell apoptosis was significantly increased in TCMK-1 cells following the concentration of H2O2 (all P ＜ 0.05);Bax/Bcl-2 and the phosphororation of JNK and p38 were obviously elevated in TCMK-1 by H2O2 induction (all P ＜ 0.05).Conclusion Oxidative injuries induced by H2O2 significantly suppresses the expression of Klotho in TCMK-1 cells.And cell apoptosis was increased,p38 and JNK pathway was activated.