Under the guidance of three-dimensional images, and the superposition of special material step by step, three-dimensional entity model can be generated. It is a new technology which has been developing rapidly in recent years. Now 3-D printing products has penetrated into every aspect of our lives, at the same time, with the progressing of 3-D imaging technology and materials engineering, 3-D printing technology are gradually applying to medical practice, including the orthopaedics, treatment of congenital heart disease and valve replacement. There are few researches about the 3-D printing technology in the application of percutaneous coronary intervention (PCI), so the paper is to preliminary explore the application of 3-D printing in PCI from three aspects of technology teaching, doctor-patient communication and surgical planning.

Individualized Quality Control Plan ( IQCP) is a method of quality control for total testing process.In January 2016, the United States formally adopted the IQCP instead of the original equivalent quality control.This article will introduce how to establish and implement IQCP in the laboratory , and discuss the common problems in the process of its application .

At present,HbA1c is regarded as the gold standard in of the diagnosis of diabetes mellitus.Point-of-care HbA1c testing is popular used in China,however,the quality assurance of POCT HbA1c lags behind that of central laboratory HbA1c testing.The quality assurance strategy for POCT HbA1c must be taken into consideration.Strategies should include risk management,personnel evaluation,troubleshooting system,quality control,proficiency testing,method validation and calibration.

This paper demonstrated the importance of Homocysteine detection. It was proved that Hyperhomocysteinemia has the evident relationship to the Cardiovascular and cerebrovascular diseases and homocysteine is a new independent factor of danger and prediction, and more attentions should be given on homocysteine in clinic. As regard to the situation that Homocysteine detection has not been popularly used in China, the authors give some advice in homocysteine detection, such as: population choosing, normal range defining, quality insurance and so on.

Objective: To evaluate the effects of expanded polytetrafluoroethylene (ePTFE) barrier membrane in guided periodontal tissue regeneration(GTR) . Methods:Nine patients with Ⅱ～Ⅲ furcation lesions were treated by guided tissue regeneration using ePTFE membrane. The membrane was retrieved 5 weeks after operation and examined by scanning electron microscopy (SEM) . Results:Large amount of lymphocytes were found on the external upper surfaces of ePTFE, with a little bacteria. The external lower surface of ePTFE was full of fibrocytes, red blood cells and lymphocytes.Conclusion:ePTFE membrane is biocompatible and can close the primary wound over a barrier which stops the downgrowth of junctional epithelium at the early stage of periodontal tissue repair after operation.

Objective To prepare the candidate reference materials for frozen mixed serum potassium, in order to calibrate and evaluate the conventional methods to achieve mutual recognition of the results.Methods Fresh sera without hemolysis,lipemia and choloplania were collected.Serum pools were packed in the freezing tube in the 1 000 (1 ml/per).Use the Single Factor Analysis of Variance(ANOVA) to evaluate the homogeneity.The short-and long-term stability [(2 -8℃,room temperature,37 ℃) and long-term (-80 ℃ ) ] were investigatedby linear regression analysis.The value was assigned by transfer from NIST SRM-956c using reference method by ICP-MS and uncertain was calculated.We observed the commutability of 25 fresh patient serum samples and 3 levels candidate RMs between reference method and three analyzed systems.The candidate RMs( refernce materials) were then distributed to 33 laboratories in Beijing to apply in routine assay by using different detection systems.Results By statistical analysis of the SPSS 17 statistical software, the F value of homogeneity test of each level candidate RMs was 0.247, 0.117, 0.162.All of them were less than F0.05 (9,20) =2.39;Stability can be last at least 12 months,30 days, 12 days and 4 days at -80 ℃, 2-8℃, room temperature and 37℃respectively.The definited values of three levels candidate RMs for potassium were (2.349 ±0.028) mol/L,(3.845 ±0.024) mol/Land (5.831 ±0.042)mol/L;Coordinate dots of 3 levels candidate RMs are all within 95% confidence interval range of 25 serums regression line.They have the same speciality as serum.In correctness verification survey of 33 clinical laboratory of conventional methods,97%bias in results The biases of 97%RMs were within the range of ±2.5%( ±1/2 CLIA′88Tea).Conclusion The homogeneity, stability and commutability of 3 levels candidate RMs all meet the requirement and the target values are assigned accurately.

Objective Using the frozen human-pooled serum samples,with values assigned by the enzyme reference procedure in laboratory network to explore the way of quantity value transfer from enzyme reference measurement system to routine ones.Methods The study is about quantity value transfer.The frozen human-pooled serum sample was assigned by the enzyme reference laboratory network including six domestic reference procedure laboratories,namely Beijing Chaoyang Hospital affiliate of Capital University of Medical Sciences,Beijing Aerospace general Hospital,Beijing Shijitan Hospital affiliate of Capital University of Medical Sciences,Peking Union Medical College Hospital,Beijing Leadman Biochemistry Co.,Ltd.and Sichuan Maker Biotechnology Co.,Ltd.,which used the reference measurement procedures of creatine kinase (CK) and lactate dehydrogenase (LDH) from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).First,the assigned serum was used to calibrate or verify trueness of routine measurement systems from the 49 laboratories of tertiary hospitals in Beijing in Feb,2013 by Beijing Centerfor Clinical Laboratories.Second,the assigned serum and two levels of patient samples were tested in duplicate by laboratory 's measurement systems after calibration with manufacturer's calibrator and with assigned serum.During this procedure,all laboratories data were collected.Harmonization of results was observed after calibration with the assigned serum according to the statistics.Results After calibration,the interlaboratory coefficients of variation (CVs) of two patient samples were decreased from 4.67％ and 5.96％ to 1.86％ and 1.47％ for CK and from 5.72％ and 5.04％ to 3.67％ and 3.62％ for LDH.For peer group of A and B instrument,after calibration,both CVs of the assigned serum and two patient samples were less than 2％ for CK,and less than 4％ for LDH ; For C instrument group,which was not calibrated with the assigned serum,the biases were-4.75％ for CK and-13.1％ for LDH,while the biggest CVs were 3.64％ for CK and 7.57％ for LDH.For peer group of reagents,after calibration,the CVs were decreased from 1.60％-4.44％ to 0.23％-1.62％ for CK and from 0.93％-6.07％ to 1.06％-2.72％ for LDH.Conclusions It is one of the feasible ways for quantity value transfer by using the frozen human-pooled serum samples,which were assigned by the enzyme reference laboratory network for calibration or verification.It can effectively solve the problem of trueness and harmonization of enzyme testing results.In addition,for those measurement systems which are not applicable for this calibration.

Objective To analyze laboratory turnaround time (TAT) and find effective ways to shorten TAT.Methods Data associated with cardiac panel (CK,cTnI and Mb) were collected in 2011 including 19 906 outpatient data and 22 973 inpatient data.The medians and the average medians of the quality indicators on TAT were calculated and the results were transformed to the Six Sigma scale to estimate the degree of control over related process.Processes were considered well controlled when σ ≥4.Based on the results of data analysis,an improvement plan was decided by laboratory quality management meeting and clinical communication meeting.The effect of the improvement plan was evaluated through 2011-2012 satisfaction surveys of outpatients and clinicians.Results The average median of overtime reports for outpatient from specimen collection to reception was 2.78％ (3.5σ),and 17.82％ (2.5σ) for inpatients.The average median of overtime reports for outpatient from specimen reception to result reporting was 3.39％ (3.4σ),and 2.96％ (3.4σ) for inpatients.The average median of overtime reports for outpatient from specimen collection to result reporting was 3.93％ (3.3σ),and 12.18％ (2.7σ) for inpatient.The results of TAT satisfaction surveys for outpatients from 2011 to 2012 were similar,which were 78％ in 2011 and 79％ in 2012; the results for clinicians showed an increase from 80％ in 2011 to 90％ in 2012,including an increase from 75％ to 79％ for very satisfaction choice.Conclusions Outside the laboratory TAT is a key step in sickroom patients delay TAT.The implementation for ten improvement suggestions enabled to shorten TAT effectively.

Objective To explore the difference of two kinds of proteolytic enzymes (GLU-C and Lys-C trypsin),hemoglobin A1c were measured in mass spectrometry.Methods Based on the IFCC recommended hemoglobin A1c reference measurement method by mass spectrometry,the blood samples were preparied (the number of these blood samples:201201,201202,201203).Hemoglobin in the samples were enzymed respectively by two kinds of proteolytic enzymes (Glu-C and Lys-C),before the mass spectra which be used solid phase extraction method,under the optimal experimental conditions,hemoglobin A1c in the sample were measured by the liquid chromatography tandem mass spectrometry and screened of variant hemoglobin with sequest software.All results by mass spectrometry are required to use the Sequest software to search RAW file in the human IPI Database,retrieve four common hemoglobin variant published results and compare hemoglobin variant sites,using statistical software SPSS13.0 and Excel 2003 on the results in the correlation analysis,compare between groups by the independent sample t test.Results In the detection of hemoglobin A1c,respectively Glu-C and Lys-C blood which the samples were enzymed,results of hemoglobin A1c by Lys-C were (34.70 ± 2.80),(51.76 ± 1.60),(73.39 ± 1.11) mmol/mol,results of hemoglobin A1c by Glu-C were(33.12 ± 1.48),(54.54 ± 2.50),(75.40 ± 3.60) mmol/mol,the difference between groups was not statistically significant,the results of two methods of drawing curve,all R2 ＞ 0.995.Searching the human database with sequest software,four common hemoglobin variant were not be finded.Conclusions In the detection of hemoglobin A1c by the mass spectrometry,the application of the above two kinds of proteolytic enzyme in the blood samples,that can be more consistent results,test results of two methods have a good correlation.

Objective To evaluate the analytical variables of the reversed-phase high pressure liquid chromatography (HPLC) with 5-Fluorouracil(5-Fu) as an internal standard for determining creatinine in human serum and urine. The method was used as a candidate reference method for accuracy assessment of routine creatinine test kits.Methods We tested the accuracy, precision, linearity of the reversed-phase HPLC.We analyzed split samples of a panel of 85 patients’ serum and 94 patients’ urine and compared the results of the routine test kits and HPLC by means of bias plots (percentage differences of results) and standard linear regression.Results The linear range of HPLC method was up to 2 210 ?mol/L, the within-run CV(n=5) was below 2.5% and the between-day CV(n=10) was less than 4.5%. The analytical recovery rate was 96.3%～102.4%. All of the test kits correlated very well with HPLC.Conclusions We recommend the reversed-phase HPLC with 5-Fu as an internal standard as a candidate reference method for determining creatinine in human serum and urine.The enzymatic method with creatininase coupled sarcosine oxidase is suitable for routine work in clinical laboratories.