“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 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.

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.

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 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.

Objective To explore the consistency of the clinical serum creatinine results in Shanghai district and investigate the population distribution of apparently healthy people, modified MDRD formula adapted to Chinese population was used to estimate glomerular filtration rate and its distribution for further assessment of the clinical applicability of the eGFR.Methods A fresh pooled human serum sample with given IFCC's creatinine level from c.f.a.s.(calibration for automatic system) ,was used to calibrate the creatinine detecting systems of each participating hospital laboratory before every examination. Fourteen hospital laboratories successively conducted 6 experiments, and the test results were almost identical.They tested and studied the creatinine values of 6 837 ( male 3 289, female 2 132, children and teenagers 1 416)apparently healthy individuals, age from 0 to 99 years old, and estimated eGFR value of these apparently healthy individuals according to the documented eGFR formula [ eGFR = 175 × (Scr) -1.154 × (age) -0.203 ×0.742 (female) × 0.827 ] which was applied especially to Shanghai people.Results Before calibration,the inter-laboratory CVs of creatinine results varied from 3.1％ -9.1％, and after calibration, CVs decreased to less than 5％.A good consistency of the creatinine results was established among all these hospitals.The result of population distribution study of creatinine for men was 63.0-102.8 μmol/L,for women was 45.0-76.0 μmol/L, and for children and teenagers was 0-1 year old 11.0-77.0 μmol/L, 2 years old 15.5-33.3 μmol/L,3-5 years old 19.0-42.0 μmol/L, 6-19 years old 41.4-62.0 μmol/L.The Cr value were different between the male and femal [ male: ( 82.1 ± 10.9 ) μmol/L, femal: ( 59.4 ± 8.4 ) μmol/L, t =94.3 ,P <0.01 ＝ ;The eGFR value could decrease the sexual difference[ male: (79.1 ± 13.5) ml · ( min ·1.73 m2 ) -1, femal: (79.2 ± 13.6) ml · ( min · 1.73 m2 ) - 1, t = 0.266, P > 0.05 ].The difference of Cr and eGFR could not be eliminated between the groups divided by every 10 years(x2Cr =2 601 ,P <0.01 ;x2eGFR2= 1 105 ,P <0.01 ＝.Conclusions The pooled patients' sera could be used as calibrator for harmonizing of creatinine results among the laboratories. The reference rang of Cr should be differentiated by age and sex.Although eGFR can decrease the difference of sex, it cannot eliminate the difference of age.

Objective To assess the analytical performance of three sensitive cardiac troponin Ⅰ assays and compare the clinical application to provide help in choosing the detection method for clinical laboratory. Methods A total of 474 serum samples were collected from apparently healthy subjects and a total of 112 serum samples were collected from patients presenting with symptoms suggestive of acute myocardial infarction. The functional sensitivities of three assays from Abbott, Beckman-Coulter and Ortho were determined ( CV = 10% ). The reference ranges have been established. The analytic performance was compared according to the assessment mode described by Apple. The relationship was compared among the different assays. The preliminary clinical application value for different detection methods has been evaluated and validated with self-established reference ranges. Results The functional sensitivities ( CV = 10% ) of the cTnI assays for Abbott, Beckman-Coulter and Ortho were 0. 030, 0. 04 and 0. 013 μg/L, respectively.The 99th percentiles of cTnI in healthy volunteers were 0. 021, 0. 02 and 0. 026 μg/L respectively. The analytical data of ROC curve showed that the area under curve (AUC) of the cTnI assays for Abbott,Beckman-Coulter and Ortho for diagnosis of AMI was 0. 852,0. 909 and 0. 910,respectively. There was no statistical difference between any two methods(Z1 = 1.18 ,Z2 = 1.21 ,Z3 =0. 026,all P ＞0. 05). There were good consistency between the 99th percentile obtained from our laboratory and suggested by manufacturers (Kappa value were 1. 000, 0. 730 and 0. 893 respectively, all P ＜ 0. 01 ). Conclusions The analytical performance of two cTnl assays is "clinical accepted" ,the other one is accepted according to guideline. All of them could detect cTnI in apparently healthy subjects. There exist differences among three assays, but their diagnostic characteristics for AMI are not significantly different.

Objective To assess the analytical performance of hs-cTnT and biological variations in healthy population as well as establish hs-cTnT reference intervals. Methods The serum samples from 100 acute myocardial infraction patients and 474 apparently healthy subjects were collected. The functional sensitivity,within- and between-run imprecision were determined. The hs-cTnT assay and con-cTnT assay were evaluated. The serum hs-cTnT levels were detected in apparently healthy subjects to establish reference intervals. Moreover,the long-term and short-term biological variations for hs-cTnT in healthy volunteers were assessed. Results The functional sensitivity of hs-cTnT was 0. 005 μg/L. The within- and between-run precision for lower level control(0. 014 μg/L) and higher level control(2. 500 μg/L) was 2. 97% vs 3. 64%and 0. 66% vs 1.01% ,respectively. The correlation between hs-cTnT assay and con-cTnT assay was good ( R2 =0. 972 ,P ＜0. 01 ). The 99th percentile in apparently healthy subjects was 0. 003 μg/L for women less than60 years, 0.008 μg/L for men less than 60 years, 0.015 μg/L for women above 60 years and 0. 021 μg/L for men above 60 years. The CVa, CVi, CVg and CVt of short-term biological variations in detecting hs-cTnT from 22 apparently healthy subjects were 3.8%, 4. 8%, 49.9% and 58.5%,respectively. The CVa,CVi ,CVg and CVt of long-term biological variations were 5. 3% ,6. 4% ,56. 6% and 68. 3% respectively. Conclusions The analytical performance of the hs-cTnT is better than con-cTnT assay,achieving acceptable level according to guideline. Our experimental result could provide the basis for the new high sensitivity cTnT assay in the diagnosis of acute myocardial infarction.