Idiopathic pulmonary fibrosis (IPF) is a specific form of chronic, progressive, fibrosing interstitial pneumonia of unknown etiology , a median survival time of which is 2 to 3 years.The diagnosis and treatment are important for IPF in time.Krebs von den lungen-6(KL-6), Surfactant protein-A(SP-A) and Surfactant protein-D(SP-D) are acceptable biomarkers in clinical for idiopathic pulmonary fibrosis in Japan,which have shown good sensitivity at diagnosis IPF and predict the prognoses for patients with IPF . However , the differential diagnosis of IPF from other interstitial lung diseases is still challenging .Other biomarkers are being developed , one of which would have the best specificity and sensitivity at diagnosis IPF.Those biomarkers about pathogenesis of IPF includes alveolar epithelial cell dysfunction , fibrogenesis and immune dysregulation are shown .They are potential to account for underlying disease mechanisms , accelerated drug development and advance clinical management.

In recent years , with the development of error theory and the requirements of the international accreditation bodies , the quality indicators ( QIs) have become one of the important tools in the laboratory quality management .To explore the evolution and origin of QIs , the status and the future of QIs will be helpful for us to understand and to use the QIs .

Laboratory developed tests ( LDT) are usually referred to the diagnostic methods for the medical laboratory , which can only be used in the medical laboratory and can not be sold to other medical laboratories , hospitals and individuals .The paper shows the draft guideline of LDT issued by Food and Drug Administration ( FDA) and the suggestions of clinical laboratory experts and relevant academic groups for different FDA monitoring models.

Objective To develop a novel method for genotyping rs 738409 ( C >G ) single nucleotide polymorphism ( SNP ) , and explore the association between the rs 738409 genotypes and non-alcoholic fatty liver disease ( NAFLD ) .Methods Method establishment and analysis of genetic susceptibility.The principle of amplification refractory mutation system ( ARMS) and combined a TaqMan fluorogenic probe as signal report were used , by monitoring the difference of cycle threshold (ΔCt=C allele-special primer Ct values minus G allele-special primer Ct values ) between the two PCR reactions in a real-time PCR, the method for rs738409 genotyping was established ( ARMS-TaqMan) .618 subjects ( men:401;women: 217 ) , in an annual health check-up program from January 2011 to December 2014 in Aerospace Center Hospital , were performed for rs738409 genotyping by the ARMS-TaqMan assay.Fatty liver was diagnosed based on abdominal ultrasonography .The chi-square test and multiple logistic analyses were used to analyze the relationship of rs 738409 genotypes and NAFLD.Results The ΔCt by ARMS-TaqMan for rs738409 genotyping were -13.1 ±1.4 of CC alleles ( 243 cases ) , 0.01 ±0.45 of CG alleles ( 282 cases), and 12.7 ±1.9 of GG alleles (93 cases), respectively.The GG alleles frequency of rs738409 were significantly higher in patients with NAFLD compared with subjects without NAFLD (21.5%vs 12.3%,χ2=8.677, P =0.003).In comparison to subjects with CC alleles, the OR (95% confidence interval) adjusted for age, gender, total cholesterol, triglyceride, high density lipoprotein-cholesterol, low density lipoprotein-cholesterol, fasting blood glucose and body mass index was 1.35 (0.91-2.00) in subjects with CG alleles and was 2.21 ( 1.32 -3.71 ) in subjects with GG alleles ( P =0.013 ) .Variant rs738409 genotypes were associated with significant increased trend in alanine aminotransferase ( ALT) level from CC alleles, CG alleles to GG alleles (F=8.980, P<0.001), and in aspartate aminotansferase (AST) between GG alleles and CC alleles (F=6.491, P<0.001).Conclusions The novel ARMS-TaqMan assay had the features of accuracy , one step and high-throughput for rs738409 genotyping.The G allele of rs738409 was a risk factor of NAFLD susceptibility and associated with higher level serum ALT and AST .

Objective To prepare the serum reference materials for total thyroxine .Methods Individual blood samples were collected from 13 healthy donors (7 males and 6 females) aged from 20 to 50 years old, and the sera were separated and mixed into 4 serum pools according to the concentration of thyroxine.The materials were tested for homogeneity and stability using routine methods .The method of isotope dilution liquid chromatography tandem mass spectrometry ( ID-LC/MS/MS) was used to determine the concentration of thyroxine .The candidate reference materials were also measured by four conventional methods to analyze the commutability of the materials .Results It showed that the four candidate reference materials were homogeneous and commutable in four conventional methods and they were tested to be stable for at least 1 year at -70 ℃using the isochronous stability study .The certified values ( reference value ± expanded uncertainty ,nmol/L) were:75.9 ±1.8,105.3 ±2.2,114.7 ±2.1 and 187.4 ±2.9.Conclusions Certified reference materials for serum thyroxine have been prepared .These materials have been approved to be the Certificate Reference Materials of GBW 09127,GBW 09128,GBW 09129 and GBW 09130.

Objective To investigate how to improve test quality by monitoring and analyzing 15 clinical laboratory quality indicators from the National Health and Family Planning Commission .Methods Data were collected from clinical laboratory department of the First Affiliated Hospital of Kunming Medical University between January 2011 and August 2015.15 quality indicators were analyzed retrospectively , including the error rate of specimen type , the coefficient variation unqualified rate of internal quality control test, the reporting rate of critical value , et al.Results The monitoring results of quality indicators basically satisfied the quality goals , except that the median of turn around time in pre-analytical phase was not established, routine internal quality control was not conducted in some laboratory tests in analytical phase and the reporting rate and reporting timely rate of critical value should be further improved in post -analytical phase .Conclusion Medical laboratory quality system can be continuously improved by means of setting up the quality goals of 15 quality indicators referring to sub-specialty and laboratory tests , as well as automated monitoring, statistics and analysis in LIS.

Objective To establish and apply the procedure of survey on quality indicator in clinical laboratory and to analyze the status in quo of the 15 quality indicators in Zhejiang province .Methods A network platform for the survey on quality indicator in clinical laboratory was designed and developed by our center.The online questionnaires that should be reported back within one month were assigned to 473 laboratories.The developed software and SPSS 13.0 were used for statistical analysis .13 indicators expressed in rate were further evaluated with sigma scales .The 25th percentile, 50th percentile, and 75th percentile of the distribution of each quality indicator were regarded as the minimum , appropriate and optimum quality specifications, respectively.Results Totally 444 laboratories submitted the survey results.The overall sigma levels of 10/13 indicators were all >3, of which the inappropriate CV of internal quality control and unacceptable performances in EQA were still less than 3σin 15.8%and 9.2%of the laboratories.The rates of quality indicators in different scales of laboratories and diverse disciplines were significantly different .Pre-analytical TAT in routine examination for clinical chemistry and immunology was 50 min, on average.And the time for routine examination of blood , urine and stool was 30 min.Pre-analytical TAT in emergency examination for all four disciplines were all between 10 and 15 min. Intra-analytical TAT for clinical immunology was the longest , which was 154 min for routine examination and 40 min for emergency examination, respectively.The optimum quality specifications for 8 indicators were 6σ, while the minimum quality specifications were less than 1σfor 4 indicators.Conclusions According to the results of our survey, the pre-analytical quality indicator perform better than that of Intra-analytical and post-analytical phase.The laboratory should strengthen the laboratory information system technology construction to ensure the reliable data collection and long-time monitoring.

The pre-examination process is the first key step in the total testing process of clinical laboratories.Specimen acceptability is an important indicator to measure the quality of pre-examination.In order to identify the risks and the root causes in the process , establishment and monitoring of quality indicators about specimen will effectively control the risks , enhance the acceptability of specimens , promote the improvement of pre-examination quality and finally get the aim of assuring patients′safety.

To evaluate the items of critical values and alert limits of the test results , to optimize the critical values report procedure , to modify the laboratory information system ( LIS ) and the hospital information system ( HIS ) , the critical values monitoring platform was designed .Through the monitoring platform,the critical value report rate and critical value report timely rate could be calculated , so reduce medical risks and improve the level of hospital management .

Quality indicator is defined as the measure used to access the degree of inherent characteristics meeting the requirements .It is a powerful tool to improve laboratory quality to monitor and evaluate performance throughout critical steps in the total testing process .Targeted quality improvement can be obtained by quantizing quality levels in each phase when the quality indicators applied .Establishing and monitoring the quality indicators enables laboratory to compare over time between providers , and evaluate the effectiveness of delivered services and improving patient safety .