“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 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.

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.

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 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 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 evaluate the performance of serum small dense low-density lipoprotein cholesterol(sdLDL-C)kit using enzymic method and evaluate the relationship with the severity of coronary heart disease.Methods Performance verification methodology. The analytical performance consisted of accuracy, precision and linearity of serum sdLDL-C kit using enzymic method was assessed. One hundred and twenty healthy persons were recruited to establish serum sdLDL-C reference interval. Two hundred and twelve patients underwent coronary angiography were enrolled in the study.Among them 110 cases were positive for coronary angiography, where as 102 cases were negative. We examined serum levels of sdLDL-C in 110 patients with positive angiography, 102 patients with negative angiography and 120 healthy volunteers. Positive group was classfied into severe group(Gensini score>30) and mild group (Gensini score≤30).Results The accuracy and precision of sdLDL-C examination were in compliance with manufacturer′s statement and there was a good linear correlation(Y=0.9937X-0.1063,R2=0.99) in range of 0.06-2.45 mmol/L. The reference interval of sdLDL-C was 0.15-0.97 mmol/L and without gender and age specificity. The level of sdLDL-C was higher in positive angiography group than in negative angiography group and healthy control group(P<0.01). The level of sdLDL-C was higher in severe group than in mild group(P<0.05). Binary stepwise regression analysis demonstrated that sdLDL-C was independently associated with the severity of coronary heart disease(OR=3.101,P<0.05).ConclusionsExperiment data demonstrated that serum sdLDL-C kit using enzymic method has good performance in the accuracy, precision and linearity. SdLDL-C that plays an important role in the occurrence and progression of coronary heart disease, is an independent important risk of the severity of coronary heart disease.

Objective To explore the correlation between sex hormone binding globulin (SHBG) and cardiovascular disease (CVD) in community elderly population.Methods In 2014,1916 elderly people (796 males,and 1 120 females) were selected from Baoshan District Friendship Community,Shanghai.We collected basic epidemiological data and fasting venous blood samples to carry out the detection of biomarkers,and then calculated their ten-year Framingham risk score.In this study,obesity,systolic blood pressure,fasting blood glucose,lipid concentration,and high-sensitive C-reactive protein were considered as CVD risk factors;Framingham risk score was considered as a CVD event prediction risk score.We analyzed the correlations of these factors with SHBG.Results SHBG mean values in the population with a history of CVD were lower than those without a history of CVD (P＜0.001).The correlation coefficient between male SHBG and waist circumference,hip circumference,BMI,systolic pressure,cholesterol,triglycerides,high density lipoprotein cholesterol,apolipoprotein A,high sensitive C-reactive protein were-0.312,-0.307,-0.266,-0.113,0.155,-0.277,0.510,0.394 and-0.130,respectively (P＜0.01).The correlation coefficient between female SHBG and waist circumference,hip circumference,BMI,fasting glucose,cholesterol,triglycerides,high density lipoprotein cholesterol,apolipoprotein A,high-sensitive C-reactive protein were-0.236,-0.248,-0.168,-0.183,0.135,-0.264,0.445,0.358 and-0.295,respectively (P＜0.001).The decrease of SHBG level was consistent with the increase of Framingham score (κ =0.062,P＜0.001).Elevated level of SHBG would reduce the risk of CVD in ten years (P＜0.01).Conclusions There was a negative correlation between baseline SHBG level and CVD risk factors,positive correlation between baseline SHBG level and CVD protection factors in community elderly population;lower SHBG level indicated higher risk of developing CVD events.

Objective To assess the applicability of the Modification of Diet in Renal Disease (MDRD)formula to kidney function impaired Chinese diabetic patients.Methods Glomerular filtration rates(GFRs)in 463 Chinese diabetic patients(219 female,244 male,aged 14 to 88)were estimated by measuring ~(99m)Tc-DTPA clearance and with equations based on serum creatinine(Scr)and cystatin C(Cys C)concentrations.GFRs derived from various equations were compared with the ~(99m)Tc-DTPA clearance GFRs and their relative accuracies were assessed with ROC analysis.All the Scr measurements were performed with both the Roche enzymatic assay and the Beckman LX20 kinetic alkaline picrate assay,and Cys C with immunonephelometric and immunoturbidimetric assays.Results The reciprocals of Cys C and Scr were linearly correlated with ~(99m)Tc-DTPA clearance GFRs(r=0.830 and 0.690,repectively).The correlation of GFR with Scr could be expressed by an adjusted MDRD equation:GFR [ ml?(min?1.73 m~2)~(-1)]=175?(Scr)~(-1.154)?(age)~(-0.203)?0.742(female)?0.827,where 0.827 was a coefficient for Chinese.The adjusted equation showed a better accuracy than the MDRD equation(areas under the ROC curve 0.818 vs 0.644).The adjusted equation was also more accurate than equations obtained in previous Chinese studies.GFRs were also estimated by using Cys(in mg/L)with the following equation:GFR [ ml?(min?1.73 m~2)~(-1)] = 63.24?(Cys C)~(-0.3378).The accuracy of the Cys equation was similar to the Scr equation,or better in patients aged 60 and above.The Roche enzymatic results which were traceable to the isotope dilution mass spectrometry(IDMS)methods were significantly lower than Beckman LX20 results,but the results were closely correlated with each other(Y = 0.94X-0.02).When non-traceable Scr results were used,the coefficient needed to be adjusted.Conclusions GFRs can be estimated with equations based on either Scr or Cys C.GFR estimation should use standardized Scr results and take into account ethnic effects.