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.

Objective To establish a method for determining oxalate and citrate in urine simultaneously by capillary electrophoresis.The components,the concentration and pH of the buffer solution,the separation voltage and the injection time on theseparation were studied in detail.Methods The separations were carried out using potassium dihydrogen phosphatebuffer ina fused-silica capillary tubeby capillary zone electrophoresis (CZE) and the detection were monitored by UV.24 h-urine samples from patients (n =5) and health control (n =5) were collected from Zhongshan Hospital of Fudan University for systematically validating the method developed.Results The optimized separations were carried out using a 50 mmol/L potassium dihydrogen phosphatebuffer solution (pH 6.5) in a fused-silica capillary tube of 50 cm × 50 μm I.D.Injections were made by using the pressure mode for 10 s at 34 mbar.The detections were monitored by a UV at 200 nm after samples were separated at avohage of 30 kV.Under the seconditions,urinary oxalate and citrate were separated completely within 5 min.The relative standard deviations of migration time and peak area within-run foroxalate and citrate were less than 1％ and 3.0％ and the betweenrun relative standard deviations were less than 2.0％ and 4.0％,respectively.The detection limits were 1 mg/L for both oxalate and citrate.The linearity ranges of oxalate and citrate were both 0-500 mg/L with the correlation coefficient between 0.999 5 and 0.995 4 (P ＜ 0.05),respectively.The average recoveries were 102.38％ for oxalate and 92.74％ for citrate.Conclusion This method is proved to be simple,sensitive and accurate,and also applied to determine oxalate and citrate in urine samples with satisfactory results.

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 investigate the significance of serum homocysteine (HCY) level in the patients with diabetic macroangiopathy, and analyze the related risk factors.Methods Case control study.279 diabetics (male 198, female 111) aged 59.6(55.0-67.0) were selected in Shanghai Zhongshan Hospital from May 2015 to February 2016.According to the medical history and Carotid intima-media thickness, they were divided into carotid artery disease group (137 cases), cardiovascular disease group (197 cases) and cerebrovascular disease group (29 cases).We detected veinal blood HCY , fasting blood glucose, glycated albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, L-, gamma glutamyl transferase, urea nitrogen, creatinine, uric acid, cholesterol, three triglyceride, high density lipoprotein cholesterol, low density lipoprotein cholesterol, glycosylated hemoglobin and albumin , creatinine in urine.The groups were compared with Mann-Whitney U test and χ2 test;Pearson correlation analysis was used to determine the correlations between HCY and other indicators;logistic regression model was used to analyze the risk factors of diabetic macroangiopathy and its subclasses;ROC curve was used to analyze the diagnostic value of HCY and uric acid in diabetic macroangiopathy.Results HCY in diabetic with macroangiopathy group was significant hiher than that in diabetic without macroangiopathy group 10.40(8.50-12.48) μmol/L 9.10(7.50-10.70) μmol/L, P<0.01).The incidence of diabetic macroangiopathy (χ2=7.030, P=0.030) and carotid artery lesions (χ2=7.258, P=0.027) was different in patients with different HCY levels.The correlation coefficients of HCY with urea nitrogen, creatinine, uric acid, urinary albumin/creatinine and estimated glomerular filtration rate (eGFR) were 0.340, 0.248, 0.278, 0.133,-0.369 (P<0.05), respectively.HCY was a risk factor for diabetic macroangiopathy, carotid plaque and cardiovascular disease;HCY, age and uric acid were independent risk factors for some of the diabetic macroangiopathy (P<0.05);HCY and UA had a certain diagnostic value for diabetic macroangiopathy(P<0.05).Conclusions Serum HCY is a risk factor for diabetic macroangiopathy, and detection of HCY levels will contribute to the diagnosis and prevention of the disease.

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.

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.

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 establish the reference intervals of serum osteocalcin (OCN), C-terminal cross-linking telopeptide of type Ⅰ collagen (β-CTx) and total type Ⅰ procollagen N-terminal peptide (P1NP) by electrochemiluminescence assay. Methods According to the Clinical and Laboratory Standards Institute (CLSI) "CA8-A" document the appropriately healthy people, who were divided into three groups (men, premenopausal women, and postmenopausal women) by sex and pre- or postmenopausal status were screened. The levels of fasting serum of OCN,β-CTx, tPINP were detected by Roche Modular E170 electrochemical immunoassay. Results 393 appropriately healthy people consists of 112 men between the ages of 29 and 69 years, 148 premenopausal women between the ages of 29 and 69 years, 133 postmenopausal women between the ages of 29 and 69 years. The levels of serum OCN, β-CTx, tP1NP in men group were (15.33±4.76) μg/L, (413±189) ng/L, (42.15±17.14) μg/L, respectively. The levels of serum OCN, β-CTx, tP1NP in premenopausal women group were (12.99±4.53) μg/L, 265(30-820) ng/L, (36.43±14.23) μg/L, respectively. The levels of serum OCN, β-CTx, tP1NP in postmenopausal women group were (18.96±5.15) μg/L, (513±195) ng/L, 51.40 (8.98 -118.6)μg/L, respectively. Logarithmic transformation produced normal distributions for all markers but serum β-CTx of premenopausal women group and serum tPINP of postmenopausal women group. The 95% of the distribution intervals for serum OCN, β-CTx, tP1NP in men group was 6.00-24.66 μg/L, 43-783 ng/L, 9.06-76.24 μg/L, respectively. The 95% of the distribution intervals for serum OCN, β-CTx, tP1NP in premenopausal women group was 4.11-21.87 μg/L, 68-680 ng/L, 8.53-64.32 μg/L respectively. The 95% of the distribution intervals for serum OCN, β-CTx, tPl NP in postmenopausal women group were 8.87-29.05 βg/L, 131-900 ng/L, 21.32-112. 80 μg/L, respectively. Conclusions Compared with the reference intervals provided by manufacture, the reference intervals of three serum bone turnover markers established by our laboratory have great difference. Laboratory should pay attention to the reference intervals was cited.