Objective To inquire into the clinical acceptability of self-developed biochemical test system by comparing the results and bias estimation with the traceable assay system.Methods According to the requests of National Committee for Clinical Laboratory Standards (NCCLS) EP-9A, comparison test and bias estimation for self-developed test system and traceable Roche reference system (HITACHI 7180) were performed by using patient's sera. The self-developed system was set up as axle Y, the traceable Roche assay system as axle X and 1/2 CLIA (%) was used as the acceptable judge standard.Results The relationship of LDL-C between self-developed system and comparison system was inferior, so the results of LDL-C as well as the low values of HDL-C were of low acceptability. The comparabilities of results of ALT, urea, creatinine, TC, ApoA1 and ApoB were acceptable.Conclusion The self-developed test system must compare with traceable assay system, and estimate its clinical acceptability. The regression equation Y=bX+a can be used to correct the bias of test result.

Objective To explore a practical way for traceability and comparability of the value obtained from clinical biochemical examination in regional medical organizations by transferring the assigned value in fresh serum to daily serum calibrator.Methods Six local comprehensive hospitals with Grade III were chosen to analyze the effects of calibration by traceability and the comparability of examined results.The definite values of standard panel in matching analytical system were transferred to fresh sera for value assignment.Verified biochemical analyzers were used to examine the values of alaninetransaminase(ALT),total cholesterol(TC),urea and total bilirubin(TBil) in mixed fresh sera and intercomparison with target system was performed to analyze the effect of traceable calibration and the comparability among various analytical systems.Results Although all the applied instruments in the present study were in good conditions with high precision,the comparability of obtained results of ALT,TC,Urea and TBil between tested system and target system was low and the differences were significant(P0.05).Conclusion Traceable precision transfer by using fresh serum is a simple,practical,feasible way to realize the traceability and comparability of regional clinical biochemical examination.

Objective To investigate the value of laboratory testing in kidney diseases and to assess whether these marks can predict the renal histological lesions for screening the best clinical test combination.Methods The main clinical data,pathological types and laboratory examination indexes in 117 patients with renal biopsy in our hospital from December 2010 to March 2014 were collected and graded according to the WHO renal pathological classification standard and the Katafuchi semi-quantitative score standard classification (Ⅰ,Ⅱ,Ⅲ,Ⅳ).The differences in serum CysC,urine NAG,urine alpha 1-MG,urine mAlb and 24 h urine total protein (24h-UTP)level were compared among the various groups and their relations with the glomerulus was analyzed;the correlation and the statistical significance of each index in different groups was analyzed.Results NAG,alpha 1-MG and CysC had statistical differences between in the grade Ⅳgroup and the gradeⅠ,Ⅱ,Ⅲ groups (P <0.05),24h-UTP and mAlb had significant correlation in reflecting the kidney diseases (r=0.565,P =0.000);NAG and alpha 1-MG also had significant correlation in reflec-ting renal tubular interstitial disease (r=0.509,P =0.000).Conclusion The detection results of various detection indicators when rising to a certain height can be used for judging the progression of the patients clinical and pathological condition,illustrating the serious condition of illness;at the same time according to the correlation among the indexes and the detection efficiency,three indi-cators of Cys C,mAlb,alpha 1 - MG are screened out for conducting the combination detection,the detection efficiency could be greatly improved.

Objective To investigate the relationship between semen trace elements and sperm density and motility in male infer‐tile patients .Methods A total of 116 cases of male infertility patients recruited in this hospital from September 2013 to September 2014 were collected and divided into the sperm density anomaly group (59 cases)and sperm motility anomaly group(57 cases) .Other 56 cases of fertile healthy men were enrolled into the control group .Sperm density and motility were analyzed and levels of calcium , phosphorus ,magnesium ,copper ,icon and zinc were detected in seminal plasma .Results Seminal level of calcium ,phosphorus ,zinc and iron in sperm density anomaly group were significantly lower than those in the control group ,while the level of copper was higher than that in the control group ,had statistically significant differences (P<0 .05) .Seminal level of copper in sperm motility a‐nomaly group was higher than that in the control group ,while levels of zinc and iron were lower than those in the control group ,had statistically significant differences (P< 0 .05) .Conclusion Sperm motility and density are significantly correlated with trace ele‐ments levels in seminal plasma .Routine determination of trace elements in seminal plasma in infertile men should be recommended , which could be helpful in fertility assessment and treatment .