“Big Data” gradually enters the field of Laboratory Medicine , there are some cases for clinical application of “Big Data”, such as quality control , reference interval , nutritional status and epidemiological investigation.There are also many challenges , such as experimental design , data accessect.Big Data mining needs more wisdom , more efforts.

Objective To evaluate the performance of serum sialic acid detection kit using enzymic method and investigate the clinical diagnosis value of sialic acid.Methods one hundred and fifty healthy adults were enrolled in this case control study to establish serum SA reference interval.The analytical performance (accuracy,precision,linearity) of serum sialic acid detection kit using enzymic method was assessed.Two hundred and forty patients were classified into different malignant tumor groups according to their pathological types.Serum SA level of each tumor group was compared with that of normal control group.In tumor groups with statistical difference,benign disease groups were further collected.Receiver operating characteristic (ROC) curve and area under curve (AUC) were used to evaluate the diagnostic value of SA compared with other tumor markers.t test,one-way ANOVA,Mann-Whitney U test were used as statistical methods.Results The reference interval of SA was 479 to 715 mg/L.The detection result of 2 level controls was 584 and 1 482 mg/L respectively,which were both within the acceptable limits.The within-lot and between-lot variations of three level samples were both below 5％.There was a good linear correlation (Y =0.995X-0.177,R2 =0.999) between theoretical value and actual detection result in range of 0-1 052 mg/L.The serum level of SA was (757 ± 177),(514 ± 86) and (597 ± 60) mg/L in gastric cancer group,benign disease control group and normal control group respectively,which had statistically significant difference(F =55.2,P ＜ 0.01).The serum level of SA was(659 ± 127) and (545 ± 66) mg/L in colorectal cancer group and benign disease control group respectively,which had statistically significant difference(F =42.8,P ＜ 0.01).The serum level of SA was (738 ± 157) and (672 ± 161) mg/L in colorectal cancer group and benign disease control group respectively,which did not have statistically significant difference(F =26.3,P ＞ 0.05).The AUC of SA was 0.804,0.724,0.755 in gastric cancer group,colorectal cancer group and lung cancer group respectively,which was higher than that of CEA and CA72-4.In gastric cancer group,the sensitivity of SA was higher than that of CEA (59.5％,24.3％).The AUC of SA was 0.791,0.687,0.790 in gastric cancer,colorectal cancer and lung cancer patients with normal CEA serum level respectively.Conclusions Experimental results show that serum sialic acid detection kit using enzymic method has good performance in the precision and linearity.Sialic acid has some value in the diagnosis of gastric cancer and colorectal cancer and could be a good supplement of CEA in screening of cancer.

Objective To investigate the methods of nursing safety management for indwelling catheters. Methods The nursing safety management measures included the establishment of three-level monitoring network of safety management for indwelling catheters,standardization of 25 kinds of catheter identification cards,formulation of prevention procedure and reporting system of catheter extrusion,design of catheter management handbook,organization of training and examination on the relative skills for nurses. Results Nurses' safety awareness of indwelling catheters was strengthened. And nurses could distinguish different catheters promptly and provide efficacious and safe nursing services. There was no nursing error,nursing dispute and patient complaints towards nursing care of indwelling catheters. Conclusion The implementation of nursing safety management for indwelling catheters can ensure medical and nursing safety,and promote the continuous improvement of quality of nursing.

Objective To investigate the urinary albumin excretion of the diabetes patients and application value in the monitoring of early impairment in kidney. Methods The random urine samples from diabetes patients and controls within three days were collectod. The changes of urinary albumin excretion within day and between days were analyzed. 24-hour urine albumin was used as a standard to evaluate early kidney damage. The correlations between results of random urine albumin at the different time points and different periods were comparod. The sensitivity and specificity of random urine albumin at the different time points and different periods was evaluated and compared to deduce the best diagnostic porformance of the random urine albumin. Results There are greater variations of the levels of urinary albumin of patients with diabetes and control. After the correction with urine creatinine and urine volume the variations can be reduced (CV:49%±23% and 64%±30%). Urinary albumin excretion rate change rhythmically within the 24 h in healthy and diabetes patients. We found the best correlation between overnight ratio of urinary concentrations of albumin and creatinine (ACR) and 24-hour urinary albumin (R2 = 0.976). It was superior to urina sanguinis (R~2 = 0.900), postprandial urine (R~2 = 0.584) and random urine (R~2 =0.791). When 24 h urinary albumin was taken as the standard, receiver operating characteristic (ROC) curve analysis showed there was significant difference between male and female(male 12.8 μg/mg urine creatinine vs female 27.0 μg/mg urine creatinine),and the the cut-off value of ACR was 27.7μg/mg urine creatinine. When the smallest available negative likelihood ratio (0.011) and the greatest positive likelihood ratio (481.000) were obtained,the concentration of 13.0 μg/mg creatinine and 87.4 μg/mg creatinine were set as the cut-off value of ACR. Conclusions The correction with urinary creatinine can reduce the variation between-days compared with urine volume, but still can not completely eliminate the variability. The ACR of overnight urine has the best correlation with the 24 h urinary albumin and can replace 24 h urinary albumin. Random urine as the most convenient collecting urine samples can also replace 24-hour urinary albumin, but the gender discrepancy need to be considered. When the concentration of 13.0 μg/mg and 87.4 μg/mg was set as a random ACR exclusion value and the confirmative value, it can basically rule out and confirm the existence of microalbuminuria.

Urinary albumin used as an important indicator in diagnosis of renal disease , but there are still many problems in the clinical application .The urine specimen type , threshold value , reference measurement procedures and some more aspect were summarized in this article .

Objective To evaluate the performance of sST 2 ELISA kit and investigate the clinical application of sST2.Methods This verification study validated the precision , linearity of sST2 ELISA kit according to the CLSI EP-15A, EP-6A protocols.300 healthy adults(aged from 20 to 85, 124 male and 176 female) from 5 different districts of Shanghai were used to establish serum sST 2 reference interval .The correlations between sST2, NT-ProBNP, LVEF and NYHA class were analyzed in 117 patients diagnosed with heart failure who were grouped according to the New York heart association ( NYHA).Receiver operating characteristic (ROC) curve was used to compare the ablity of sST2, NT-ProBNP, LVEF in distinguishing heart failure patients .Results The within-lot and between-lot variation of three level samples were below 4% and 10% respectively.There was a good linear correlation ( Y=0.995X+0.005, R2 =0.999) between theoretical value and actual detection result in the range of 0 to 200 μg/ml.The reference interval of sST2 was 10.2 to 41.0μg/ml for males and 8.9 to 28.1μg/ml for females.sST2 was positively correlated with NT-ProBNP and NYHA class but did not correlate with LVEF in heart failure patients . Patients with NYHA class>II (Median:28.3,IQR:19.5-39.2)had higher serum sST2 level than patients with NYHA class≤II (Median:45.1,IQR:34.1 -85.6), P<0.05.The AUC of sST2 in distinguishing heart failure patients from normal people was 0.815(sensitivity :51.2%,specificity:92.7%).The AUC of sST2 ,sST2+NT-ProBNP and sST2+NT-ProBNP+LVEF in distinguishing patients between NYHA class≤II and>II were 0.743, 0.810, 0.831 respectively and the sensitivity of sST 2 +NT-ProBNP+LVEF was 94.7%.Conclusions Experimental results show that this sST 2 ELISA kit has a good performance in the precision, linearity.sST2 correlates with NT-ProBNP and NYHA class but do not correlates with LVEF . Serum sST2 level is not influenced by age , BMI, renal function.sST2 could be a good supplement of NT-ProBNP and LVEF in distinguishing patients between NYHA class≤II and>II.

0.05 ), the postoperative complication and mortality rate of PG group were 13.7% and 6.8%, of TG group was all 6%.Conclusions:Proximal and total gastrectomy treatment does not significantly influence the prognosis of patients with cardia and esophgogastric junction cancer in progressive stage.

Objective To set quality goals of conventional biochemical tests through the research of biological variation of the 32 routine items in Chinese population to provide the basis for Chinese clinical and laboratory standards.Methods According to the experimental designs and computing methods from foreign counterparts,the results of biological variation,individual indexes and quality goals were calculated through the serum detection of 22 subjects from clinical laboratory of Zhongshan Hospital in Shanghai (male 12,female 10,ages varying from 20 to 40 years old,median age 30) in short-term (five blood draws within one day at 8:00,10:00,12:00,14:00 and 16:00) and long-term (one blood draw at 8:00 in 6 weeks consecutively) and serum controls (mixed from healthy people).Results (1) Based on the results of shortterm and long-term biological variation in 32 routine itens,the individual indexes and quality goals were obtained.(2)The influence of diet on the biological variation of part of the test items could be observed,especially free fatty acid (the mean value of post-meal was less than pre-meal about 30％),and then followed by high-sensitivity C-reactive protein (the mean value of post-meal was lower than pre-meal about 20％) and triglyceride (the mean value of post-meal was higher than pre-meal about 10％).(3)There were some differences between the quality goals we accessed and the the indicators from Europe and CLIA.Conclusions (1)The results of apolipoprotein E and free fatty acid in this study made up for the inadequate of the European biology database.(2) Only a small part of the 32 routine items were affected by dietary factors.(3) Most quality goals obtained from this study generally consisted with Europe biology quality goals,but a few items existed different.(4)It's more practical and effective to use the results of biological variatiou than CLIA standards for setting up quality goals.

Background During the past two decades, a number of rating scales were developed to facilitate diagnosis and assessment of subjects with social anxiety disorder. One of the most commonly used scales for the assessment of social anxiety disorder is the Liebowitz social anxiety scale (LSAS). The LSAS is widely used in epidemiologic investigations and clinical researches,and its assessment in the pharmacotherapy efficacy for social anxiety disorder is superior to any other scale. So we designed this study to explore the validity and reliability of the LSAS in Chinese patients with social anxiety disorder and normal control, and to find the difference of the scores between the patients self -report version and clinician-administered version. Methods Fifty five patients meeting the DSM-Ⅳ diagnostic criteria for social anxiety disorder and 168 normal controls who were screened from 222 college students were rated by LSAS, social phobia scale and self-made General Information Forms. Results The Cronbath α of LSAS for the patients and the normal controls was 0.83 and 0.77, respectively. The 4-week test-retest reliability for total scores and its factors scores of LSAS in 31 normal controls were ranging from 0.68 to 0.79. The ROC area under curve value in discriminating the patients from normal controls was 0.87±0.03; the total score of 35 was considered to be the best cut-off score for LSAS, then its sensitivity was 0.77 and its specificity was 0.81; and no significant difference between the self-report version and clinician-administered version. Conclusions The LSAS is good in internal consistency and test-retest reliability, and has high sensitivity and specificity in discriminating the patients and the controls. There is no significant difference in the total score and each factor scores of LSAS between self-report version and clinician-administered version.

Objective To analyze differences of serum proteins measurements by different methods in different systems and investigate whether the assigned serum valued by ERM-DA470k/IFCC can replace ERM-DA470k/IFCC in clinical measurements to promote the harmonization of serum proteins measurements.Methods Serum specimen was collected from 100 medical examination persons in Zhongshan Hospital (Jun 2012; age:27-73; 47 male and 53 female).Serum IgA,IgG,IgM,C3c,C4,TRF and PA of health persons,ERM-DA470k/IFCC and the assigned valued by ERM-DA470k/IFCC were measured by Hitachi 7600 (Roche and DiaSys reagents),Siemens BN Ⅱ (Siemens reagent) and Beckman IMMAGE (Beckman reagent),respectively.ERM-DA470k/IFCC was used as a calibrator to value the mixed serum.Serum proteins results obtained from the same methods were compared by T test and Wilcoxon test,and analysis of variance and Firendman test were used to compare results from different methods.The correlation of two groups was analyzed by linear regression.Results The differences of serum proteins results measured by two immunonephelometries,two immunoturbidimetries and all assays were statistically significant (P ＜0.05),respectively.The serum proteins results measured by two immunoturbidimetries showed good correlation (R2 were all above 0.97 except for C3c).In contrast,the serum proteins results measured by two immunonephelometries show poor correlation (R2 were all ranged from 0.90 to 0.94) except for IgM (above 0.96).The serum IgA,IgG and IgM results measured by different methods show good correlation (R2 were all above 0.95) Based on certified values of ERM-DA470k/IFCC,serum protein results measured by different methods could be harmonized,and got similar results from the assigned serum (P ＞ 0.05).Conclusions There is significant difference of serum proteins results detected by different methods.The ERM-DA470k/IFCC and certified serum can make serum protein results obtained from different methods harmonized.