Search

Although the mortality rate of papillary thyroid carcinoma (PTC) is relatively low, the recurrence rates of PTC remain high. The high recurrence rates are related to the difficulties in treatment. Gene expression profiles has provided novel insights into potential therapeutic targets and molecular biomarkers of PTC. The aim of the present study was to identify mRNA signatures which may categorize PTCs into high-and low-risk subgroups and aid with the predictions for prognoses. The mRNA expression profiles of PTC and normal thyroid tissue samples were obtained from The Cancer Genome Atlas (TCGA) database. Differentially expressed mRNAs were identified using the ‘EdgeR’ software package. Gene signatures associated with the overall survival of PTC were selected, and enrichment analysis was performed to explore the biological pathways and functions of the prognostic mRNAs using the Database for Visualization, Annotation and Integration Discovery. A signature model was established to investigate a specific and robust risk stratification for PTC. A total of 1,085 differentially expressed mRNAs were identified between the PTC and normal thyroid tissue samples. Among them, 361 mRNAs were associated with overall survival (P

A salt-tolerant, Gram-negative, rod-shaped and yellow-pigmented bacterium, designated strain AY-3RT, was isolated from rhizosphere soil of a desert xerophyte, Haloxylon ammodendron, sampled at Badain Jaran Desert, Alxa region, Inner Mongolia, PR China. Growth of this strain was observed at 20–42 °C (optimum, 28–30 °C), at pH 6.0–9.0 (optimum, pH 6.0–7.0) and at 0–8 % (w/v) NaCl (optimum, 3 %). Results of phylogenetic analysis based on 16S rRNA gene sequences showed that strain AY-3RT was a member of the genus Altererythrobacter , with the highest similarity to Altererythrobacter aerophilus Ery1T (97.6 %), followed by Altererythrobacter xinjiangensis S3-63T (96.9 %). The predominant fatty acids (>10.0 %) were C18 : 1ω7c, C17 : 1ω6c and summed feature 3 (C16 : 1ω7c and/or C16 : 1ω6c). The major polar lipids were diphosphatidylglycerol, phosphatidylcholine, phosphatidylethanolamine, phosphatidylglycerol, sphingoglycolipid and one unknown polar lipid. The predominant respiratory quinone was ubiquinone-10. The G+C content of the genomic DNA of strain AY-3RT was 66.3 mol%. On the basis of the data from this polyphasic taxonomic study, strain AY-3RT represents a novel species of the genus Altererythrobacter , named Altererythrobacter rhizovicinus sp. nov. (=MCCC 1K03572T=KCTC 72280T).

Background This study aimed to comprehensively evaluate laboratory quality in China and explore factors affecting laboratory errors through analyzing the external quality assessment (EQA) results of quality indicators (QIs). Methods According to model 3 (interpretive) of the proficiency testing scheme, the National Center for Clinical Laboratories of China (CNCCL) developed a questionnaire for 15 QIs. Clinical laboratories from different provinces of China participated in the EQA program of QIs annually and submitted data via an online reporting system named Clinet-EQA. The results of QIs were expressed in percentage and sigma value or minute. Three levels of quality specifications (QSs) were defined based on percentile values. Furthermore, the QIs were analyzed by disciplines, hospital scales and information construction levels of participant laboratories. Results A total of 3450 laboratories nationwide continuously attended the EQA program and submitted complete data from 2015 to 2018. The performance of most QIs has improved year by year. QIs in post-analytical gained the best performance with sigma values that varied from 5.3σ to 6.0σ. The comparison of results among different disciplines showed significant differences for five QIs. More than half of QIs had statistical differences among different hospital scales measured by hospital grades and number of hospital beds. The performance of nine QIs were influenced by information construction levels of participant laboratories. Conclusions The overall laboratory quality in China has improved since the initiation of EQA program for QIs, but the performance of some QIs was still unsatisfactory. Therefore, laboratories should make efforts for continuous quality improvement based on information provided by QSs.

Objective To investigate the value of platelet count in evaluating the degree of liver fibrosis in patients with chronic hepatitis B (CHB). Methods A total of 158 CHB patients who underwent liver biopsy in our hospital were included, and the clinical characteristics of these patients were retrospectively analyzed. The diagnostic values of platelet count, aspartate aminotransferase‐to‐platelet ratio index (APRI), and the fibrosis index based on four factors (FIB‐4) for significant fibrosis (F ≥ 2) and early cirrhosis (F = 4) stages in CHB patients were assessed by the use of receiver operating characteristic (ROC) analysis. Results The median (F0: 221.0; F1: 210.0; F2: 188.0; F3: 171.0; and F4: 155.5) and mean rank (F0: 120.4; F1: 100.1; F2: 82.2; F3: 67.9; and F4: 49.5) of platelet count decreased along the aggravation of fibrosis (F0‐F4). The areas under the ROC curve for the platelet count in diagnosis of significant fibrosis stage was 0.70, which had no significant difference with FIB‐4 (0.73) and APRI (0.68) in diagnostic efficacy (P = .428). The areas under the ROC curve of platelet count in diagnosis of early cirrhosis were 0.72, which had no significant difference with FIB‐4 (0.76) and APRI (0.68) (P = .094). Conclusion The platelet count, as a simple and non‐invasive index, could evaluate the degree of liver fibrosis in CHB individuals. At the same time, the diagnostic efficiency of platelet count to evaluate the significant liver fibrosis and early cirrhosis is comparable to FIB‐4 and APRI.

Background This study aimed to evaluate the ability of comment providers who were responsible for interpreting results in clinical laboratories in China and to improve the quality of interpretative comments. Methods Basic information and interpretative comments for five cases of 1912 routine chemistry External Quality Assessment (EQA) participant laboratories were collected by web-based EQA system in May 2018. EQA organizers assigned scores to each key phrase of comments based on predetermined marking scale and calculated total scores for each participant’s answer. Final scores and ranking were calculated according to scores of cases. Finally, we comprehensively analyzed the type of hospital and the professional title of participants. Results In total, 772 clinical laboratories, 1472 participants, from different Chinese provinces submitted interpretative comments. Median scores, interquartile ranges and score ranges of the five cases were 13 (11–15, 1–20), 13 (10–16, 0–20), 15 (12–17, 0–21), 7 (5–9, −2 to 14) and 12 (10–13, −2 to 18). The final scores and ranking of participants that came from tertiary hospitals were higher than those from secondary and other hospitals; however, there were no significant differences (0.774). When grouped by professional title, we found that although no significant variability existed among senior, intermediate, junior and others (0.699), it existed between laboratory physicians and technicians, as the median final scores of the former were higher than the latter. Conclusions Practice and quality of interpretative comments are indeed different among different laboratories and participants in China. Laboratories should train and assess the interpretative ability of personnel. EQA organizers should also improve the scoring method and establish peer assessors team through this survey.

Objective To understand the reasons for proficiency testing (PT) failures, toward the goal of continuous improvement of laboratory services. Methods Laboratories participating in PT of routine chemistry testing provided by the National Center for Clinical Laboratories (NCCL) of China were given 3 schemes for handling PT failures in 2016. If they had unsatisfactory PT performance, they were notified and requested to investigate failure errors and submit data regarding those errors. Results Failure types were distributed as follows, per error group: Clerical, 10.2%; Methodological, 16.2%; Equipment, 23.6%; Technical, 37.4%; PT Evaluation, 0.5%; Unexplained, 11.5%; and Other, 0.7%. Reasons unique to the PT process accounted for 15.6% of all reasons. Corrective actions mainly included correcting calibration, maintaining or changing equipment, strengthening reagent management, rewriting procedures, and retraining staff members. Conclusions The causes for PT failures relate mainly to laboratory problems, not to the PT process itself. Therefore, PT sponsored by the NCCL is an effective evaluation tool for laboratory performance. Also, laboratories should strive to improve analytical performance.

Background: Internal quality control (IQC) is essential for precision evaluation and continuous quality improvement. This study aims to investigate the IQC status of blood gas analysis (BGA) in clinical laboratories of China from 2014 to 2017. Methods: IQC information on BGA (including pH, pCO2, pO2, Na+, K+, Ca2+, Cl−) was submitted by external quality assessment (EQA) participant laboratories and collected through Clinet-EQA reporting system in March from 2014 to 2017. First, current CVs were compared among different years and measurement systems. Then, percentages of laboratories meeting five allowable imprecision specifications for each analyte were calculated, respectively. Finally, laboratories were divided into different groups based on control rules and frequency to compare their variation trend. Results: The current CVs of BGA were significantly decreasing from 2014 to 2017. pH and pCO2 got the highest pass rates when compared with the minimum imprecision specification, whereas pO2, Na+, K+, Ca2+, Cl− got the highest pass rates when 1/3 TEa imprecision specification applied. The pass rates of pH, pO2, Na+, K+, Ca2+, Cl− were significantly increasing during the 4 years. The comparisons of current CVs among different measurement systems showed that the precision performance of different analytes among different measurement systems had no regular distribution from 2014 to 2017. The analysis of IQC practice indicated great progress and improvement among different years. Conclusions: The imprecision performance of BGA has improved from 2014 to 2017, but the status of imprecision performance in China remains unsatisfying. Therefore, further investigation and continuous improvement measures should be taken.

The results of trueness verification for blood lead measurement were analyzed in a 2016 nationwide external quality assessment (EQA) survey, in order to evaluate current approaches of blood lead measurement in Chinese Laboratories and their traceability to certified reference materials (CRMs). A panel of 2 frozen whole blood CRMs with values assigned by an absolute quantitative method was provided to 12 laboratories with satisfactory performances from the 2015 blood lead EQA scheme. Participants were required to measure the samples 5 times each day for 3 consecutive days and report all 15 data, which were then calculated for means and standard deviations. Data were statistically analyzed by adopted method groups, before comparing with the assigned values to assess the trueness of blood lead measurement using different approaches. Eleven laboratories reported on schedule, rendering a reporting rate of 91.7 %. The target values for the two batches were (37.6 ± 2.7) μg/L and (124.6 ± 4.5) μg/L, respectively. By the evaluation criterion of target value ± 20 µg/L, the pass rates were 72.7 % for the lower concentration and 54.5 % for the higher concentration, while 5 out of 11 laboratories delivered satisfactory results for both CRMs. The overall performance of the few participating laboratories in this EQA survey was basically acceptable by CLSI standard on the whole, yet barely desirable for the higher concentration. Therefore, trueness verification of blood lead measurement with CRMs is potentially necessary for national EQA schemes, which can be imperative as part of the validation procedures of analytical methods in clinical settings.

Introduction Prenatal screening and diagnosis is important for the detection of birth defects and genetic diseases. The nationwide proficiency testing (PT) of maternal serum prenatal screening in second trimester in China has been launched since 2003 and partly reflected the performance of screening laboratories. This study analysed the 2015 PT results to examine the performance of clinical laboratories and different platforms. Materials and methods Fifteen lyophilized samples with different concentrations divided into three panels, were distributed to 613 clinical laboratories in 2015. Acceptable performance was defined as scores more than 80% of acceptable responses with the evaluation criterion of ± 30%. The robust coefficient of variation (CV) was also analysed. Chi-square (χ2) test was used to compare the acceptable performance while Kruskal-Wallis test and Mann-Whitney test were applied to compare the robust CV among analytes and mainstream platforms. Results Overall, 605, 61, 214, 416, 303 laboratories submitted effective results for alpha fetoprotein (AFP), total human chorionic gonadotropin (t-hCG), β-hCG, unconjugated estriol (uE3) and free β-hCG. The acceptable performances of AFP (μg/L), AFP (KIU/L), t-hCG, β-hCG, uE3, and free β-hCG were 98.45%, 99.24%, 95.58%, 98.72%, 94.50%, and 98.66%, respectively. The χ2 test indicated significant differences existed in the acceptable performances among different analytes and platforms for uE3. Kruskal-Wallis test and Mann-Whitney test suggested the robust CV differed significantly in different analytes and platforms. Conclusions The majority of results were acceptable. However, further effort is needed to achieve the standardization and harmonization among analytes and various platforms, particularly for uE3.

Haloxylon ammodendron, a C4 perennial, succulent and xero-halophytic shrub, is highly resistant to harsh environments, therefore, exploring the stress resistance mechanism will be beneficial for the use of xerophytes to prevent desertification. To determine osmotic adjustment (OA) and antioxidase functions under simulated drought stress, 8-week-old seedlings were treated with sorbitol solutions to maintain osmotic potentials (Ψs) at a control and −0.5 and −1.0 MPa. Under −0.5 MPa osmotic stress, H. ammodendron stably maintained the water content of assimilating branches, a result that was not significantly different from the result of the control group. Moreover, the Ψs decreased significantly, which helped plants absorb water efficiently from the environment, as H. ammodendron accumulated massive osmotic regulators in its assimilating branches to adjust shoot Ψs. Specifically, the contribution of Na+ to shoot Ψs was up to 45%, and Na+ became the main osmotic regulator of OA. During the treatments, the content and contribution of K+ remained stable. However, the total contribution of three organic osmotic regulators (free proline, betaine and soluble sugar) was only 20%, and betaine was the main organic osmotic regulator, accounting for approximately 15% of the 20% contribution. Moreover, H. ammodendron seedlings presented strong antioxidases, especially when there was a high activity level of superoxide dismutase, and with an increase in treatment time and degree of osmotic stress, the activity of peroxidase and catalase increased significantly. Substantial accumulation of osmotic adjustment substances was an important strategy for H. ammodendron to cope with simulated drought stress, in particular, H. ammodendron absorbed much Na+ and transported Na+ into the assimilating branch for OA. The scavenging of reactive oxygen species by antioxidases was another adaptation strategy for H. ammodendron to adapt to simulated drought stress.

BACKGROUND To analyze the 2017 external quality assessment (EQA) results of newborn screening by MS/MS of amino acids by Chinese National Center for Clinical Laboratories, this study aimed to reflect the performance of clinical laboratories. METHODS Five dried blood spots were distributed to participants every round. Satisfactory performance was defined as scores more than 80 of acceptable results within the evaluation criterion. The robust coefficient of variability (RCV) of each sample was calculated by measurement systems. The chi-square () test was used to compare the correct recognition rates. RESULTS EQA results were collected from 150 laboratories for Ala, Val, Arg, Leu, Met, Phe, Tyr, Cit. The overall acceptable rates of the qualitative results were 87.42%, 92.72%, 73.33%, 94.04%, 92.72%, 94.70%, 92.72%, 94.04%, respectively, and the proportion of acceptable quantitative results were 76.51 %, 91.95%, 78.38 %, 92.62%, 93.29%, 93.29%, 94.63%, 91.28%, respectively. There were significant differences in the rates of acceptable quantitative results among different items and between four methods. CONCLUSIONS Most of the participant laboratories had satisfactory performance for the quantitative results in this EQA scheme. But for qualitative assessment, the laboratory should re-evaluate and validate their reference intervals on a regular basis to improve the consistency of clinical assessment.

Background This study observed and analyzed the internal quality control (IQC) of cystatin C (CysC) so that we can have overall knowledge about imprecision levels in Chinese medical laboratories. Methods Using the software developed by the National Center for Clinical Laboratories (NCCL), we can get the IQC information of CysC from 2014 to 2017. Then the proportion of laboratories meeting five quality specifications (pass rates) were calculated and the current CVs (coefficient of variation) were also compared among subgroups and years. Results We find that the current CVs between 2014 and 2017 show significant differences (p = 0.016) and the proportion of laboratories meeting the 1/3 TEa specification distributes randomly from 2014 to 2017 but all of them exceed 80 percent. When the optimum specification is applied, the pass rates all become very low and the distributions are wide spread (from 3.63% to 6.74%). Beckman, Roche, and Hitachi are mainstream analyzers, making up as much as 78% to 85% of all. We can see a significant difference of the pass rate between Beckman and Hitachi in 2014 (p = 0.005). The primary means of detecting CysC is particle-enhanced turbidimetric immunoassay (PETIA) which makes up 30.57% - 32.64% of detection methods. The good news is that the IQC practice has improved greatly from 2014 to 2017 in laboratories in China. Conclusions Medical laboratories have made some progress in IQC from 2014 to 2017, but it is still not satisfactory. As a result, there is a long way to go to improve detection quality of laboratories in China.

Background This study aimed to investigate and analyze the status of internal quality control (IQC) for BNP and NT-proBNP from 2014 to 2017, so as to have an integral understanding of quality performance of measurement in clinical laboratories in China. Methods The 4-year IQC information for BNP and NT-proBNP of participant laboratories were collected through EQA reporting system. Percentages of laboratories meeting different quality requirements (pass rates) for current coefficient of variations (CVs) were calculated afterwards. Further analysis for current CVs and pass rates among different years and measurement systems were conducted. Finally, we analyzed and summarized IQC practice and its changes in 4 years. Results The current CVs for BNP and NT-proBNP have decreased significantly from 2014 to 2017, and pass rates both presented significant increasing trends. NT-proBNP had higher pass rates than BNP regardless of 1/3TEa or 1/4TEa specification was used. The main measurement systems for two analytes were different. For NT-proBNP, current CVs of Roche has decreased significantly among 4 years and were significantly lower than Radiometer and BioMerieux in 2015. Current CVs of Abbott also had decreasing tendency for BNP. Analysis of IQC practice indicated that control rules and IQC frequency had made great progress in 4 years. Conclusion The imprecision performance of measurement of BNP and NT-proBNP has improved with decreasing of current CVs and increasing of pass rates in 4 years. However, it still needs continual improvement. Clinical laboratories in China should take active actions to promote performance of BNP and NT-proBNP measurement.

Background This study aimed to evaluate the performance of HbA1c measurement systems quantitatively with sigma metric and promote the quality improvement. Methods 1066 laboratories enrolled external quality assessment (EQA) and reported their internal quality control (IQC) data for HbA1c in 2017 were included in this study. The bias and coefficient of variation were collected from EQA and IQC program designed by the National Center for Clinical Laboratory. The σ values was used to assess the performance of HbA1c, and combine Westgard Sigma Rules™ to select proper quality control rules in every laboratory. Results Totally, There were 388,190,185,100,59,55,89 participants used Bia-Rad HPLC, TOSOH G7/G8, ARKRAY HA8160/8180, HUIZHONG MQ-2000/2000PT, Roche, Primus HPLC and “Others” system, respectively. “HUIZHONG MQ-2000/2000PT” group had the smallest variation of bias. 56.19% (599/1066) of laboratories met bias criterion and 55.63% (593/1066) satisfied imprecision criterion. However, sigma metrics indicated that 80.21% (855/1066) of 1066 laboratories needed to improve their performance of HbA1c. Moreover, “TOSOH G7/G8” group had the highest constituent ration of σ ≥ 3. Conclusions The analytical quality of HbA1c in most laboratories need improving. Laboratories should pay more attention on the performance of HbA1c, and EQA organizers in China should improve evaluation criteria and push standardization work for HbA1c.

Introduction This survey was initiated to obtain knowledge on the current situation of internal quality control (IQC) practice for tumour markers (TMs) in China. Additionally, we tried to acquire the most appropriate quality specifications. Materials and methods This survey was a current status survey. The IQC information had been collected via online questionnaires. All of 1821 clinical laboratories which participated in the 2016 TMs external quality assessment (EQA) programme had been enrolled. The imprecision evaluation criteria were the minimal, desirable, and optimal allowable imprecisions based on biological variations, and 1/3 total allowable error (TEa) and 1/4 TEa. Results A total of 1628 laboratories answered the questionnaires (89%). The coefficients of variation (CVs) of the IQC of participant laboratories varied greatly from 1% (5th percentile) to 13% (95th percentile). More than 82% (82 - 91%) of participant laboratories two types of CVs met 1/3 TEa except for CA 19-9. The percentiles of current CVs were smaller than cumulative CVs. A number of 1240 laboratories (76%) reported their principles and systems used. The electrochemiluminescence was the most used principle (45%) and had the smallest CVs. Conclusions The performance of laboratories for TMs IQC has yet to be improved. On the basis of the obtained results, 1/3 TEa would be realistic and attainable quality specification for TMs IQC for clinical laboratories in China.

Introduction Specimen adequacy is a crucial preanalytical factor affecting accuracy and usefulness of test result. The aim of this study was to determine the frequency and reasons for rejected haematology specimens, preanalytical variables which may affect specimen quality, and consequences of rejection, and provide suggestions on monitoring quality indicators as to obtain a quality improvement. Materials and methods A cross-sectional survey was conducted and a questionnaire was sent to 1586 laboratories. Participants were asked to provide general information about institution and practices on specimen management and record rejections and reasons for rejection from 1st to 31st July. Results A total survey response rate was 56% (890/1586). Of 10,181,036 tubes received during the data collection period, 11,447 (0.11%) were rejected, and the sigma (σ) was 4.6. The main reason for unacceptable specimens was clotted specimen (57%). Rejected specimens were related to source department, container type, container material type, transportation method and phlebotomy personnel. The recollection of 84% of the rejected specimens was required. The median specimen processing delay in inpatient, outpatient and emergency department were 81.0 minutes, 57.0 minutes and 43.3 minutes, respectively. Conclusions Overall, rejection rate was a slightly lower than previously published data. In order to achieve a better quality in the preanalytical phase, haematology laboratories in China should pay more attention on training for phlebotomy and sample transportation, identify main reasons for clotted specimen and take effective measures. The platform in the study will be helpful for long-term monitoring, but simplification and modification should be introduced in the following investigation.

In this paper, an optimal semi-continuous process for vinegar production from edible alcohol through biotransformation by acetic acid bacteria (AAB) WUST-01 was developed. The optimized medium composition for the starting-up stage was glucose 5.1 g/L, yeast extract 26.2 g/L, and ethanol 11.9 mL/L, and the optimal ethanol for the following semi-continuous stage was 50 mL/L. In the semi-continuous biotransformation process, the optimal withdraw ratio was 50% of working volume with 12 h cycle time. With these conditions, the total acidity could reach to 77.3 g/L and the acidity productivity could reach to 3.0 g/(L h) in a 5 L reactor. Furthermore, it was investigated to strengthen vinegar synthesis through enhancing alcohol dehydrogenase and aldehyde dehydrogenase activity in AAB by ferrous ion and pueraria flower extract as the enzyme regulators. With these regulators, the vinegar synthesis efficiency can be improved 16.3 and 13.2% respectively.

Background This study aims to investigate the imprecision of internal quality control of routine chemistry analytes so that we can have an overall knowledge of imprecision level of measurement in laboratories in China. Methods The internal quality control information including two kinds of coefficient of variations (CVs) of 22 analytes were collected via an on-line questionnaire. Then, the percentages of laboratories meeting the quality requirement for each analyte were calculated according to five imprecision criteria. Results Among these 22 analytes, creatine kinase got the most satisfied result, the percentages of laboratories whose current CV met 1/3 total allowable error (1/3TEa), 1/4TEa, and the specifications based on biological variation were 99.3%, 95.9%, 99.6%, 99.9%, and 90.6%, respectively, while Na got the lowest satisfaction rate according to these specifications, which were 4.15%, 22.4%, 4.2%, 9.0%, and 1.3%, respectively. From an overall perspective, most of the 22 analytes got a satisfied result when applying the criteria defined by CLIA'88, while only a small amount of laboratories can meet the requirement when applying the specifications derived from biological variation. Conclusions There is huge space for us to enhance and substantial effort is needed in improving and implementing quality management in China.

Introduction The aim of the study was to investigate the state-of-the-art of the performance of critical value reporting and provide recommendations for laboratories setting critical value reporting time frames. Materials and methods The National Centre for Clinical Laboratories in China initiated a critical value reporting investigation in 2015. A questionnaire related to critical value reporting policy was sent to 1589 clinical laboratories in China online. The questionnaire consisted of a set of questions related to critical value reporting policy and a set of questions related to timeliness of critical value reporting. The survey data were collected between March and April 2015. Results A total survey response rate was 61.2%. The critical value unreported rate, unreported timely rate, and clinical unacknowledged rate of more than half of participants were all 0.0%. More than 75.0% of participants could report half of critical values to clinicians within 20 minutes and could report 90.0% of critical values to clinicians within 25 minutes (from result validation to result communication to the clinician). The median of target critical value reporting time was 15 minutes. "Reporting omission caused by laboratory staff", "communications equipment failure to connect", and "uncompleted application form without contact information of clinician" were the three major reasons for unreported critical value. Conclusions The majority of laboratories can report critical values to responsible clinical staff within 25 minutes. Thus, this value could be recommended as suitable critical value reporting time frame for biochemistry laboratories in China. However, careful monitoring of the complete reporting process and improvement of information systems should ensure further improvement of critical value reporting timeliness.

Background Clinical laboratory tests are important for clinicians to make diagnostic decisions, but discrepancies may directly lead to incorrect diagnosis. We would like to introduce some statistical methods to evaluate the comparability of chemistry analytes while comparing the performances of different measurement systems. Methods We used a panel of 10 fresh-frozen single donation serum samples to assess assays for the measurement of glucose and other 13 analytes. Statistical methods used in this article include traditional statistical analysis, robust statistics, regression analysis and differences on medical decision levels (MDL). All the statistical analysis results would be evaluated. 20 Chinese tertiary hospitals accredited to ISO 15189 took part in this work. The commercial random access platforms included: Olympus (8 labs), Hitachi (6 labs) and Roche (6 labs). To compare the acceptable rates, Chi square test was used. Results The statistical analysis results are as follows: (1) Coefficient of variations are between 2.8 and 3.9 %, with the slopes and intercepts of regression functions between 0.928 to 1.064 and −0.174 to 0.630, respectively. (2) The percentage of robust z-scores between −2 and 2 is bigger than 90 %. (3) The total percentages of differences on all the MDLs are: less than optimal was 31.7 % (19/60); less than desirable was 60.0 % (36/60); less than minimum was 65.0 % (39/60); more than minimum was 35.0 % (21/60). In this study, 2 laboratories (Nos. 8 and 16) were considered as poor performance by z-scores. 10 laboratories (Nos. 4, 5, 7, 8, 9, 10, 11, 14, 16 and 19) have unacceptable measurement errors on MDLs. 10 laboratories (Nos. 1, 2, 3, 6, 12, 13, 15, 17, 18, 20) can achieve mutual recognition of serum glucose testing results, including: 5 (5/8) Olympus, 2 (2/6) Hitachi and 3 (3/6) Roche. There was no significant difference among acceptable rates of the three measurements systems for the serum glucose assay. Conclusions Traditional statistical analysis, robust statistics and robust z-score, fitting linear regression equations and calculating differences on different MDLs can be used on studying the comparability and mutual recognition of clinical chemistry analytes among hospitals or laboratories in China. The mutual recognition and interchangeability of results remains jeopardized even among tertiary hospitals in China. More works and efforts should be done for improvement of the current situation of interchangeability of results in clinical laboratories in China.

Background To investigate the current status of IQC practice of neonatal screening in China. Methods The IQC data of Phe and TSH testing were collected. Coefficient of variations (CVs) and cumulative CVs of every month in 2014 were compared with the 1/3 and 1/4 TEa. Results Of the 219 laboratories, the return rates ranged from 71.23% to 89.95% of 12 months in 2014. The rates of CVs for 2 lots less than 1/3 TEa were 60.27% and 68.78% (Phe), 67.05% and 65.68% (TSH); less than 1/4 TEa were 32.10% and 35.99% (Phe), 32.35% and 27.55% (TSH); rates of cumulative CVs less than 1/3 TEa were 57.89% and 65.98% (Phe), 61.21% and 60.93% (TSH); less than 1/4 TEa were 29.61% and 30.74% (Phe), 27.48% and 22.41% (TSH). Conclusions The testing capabilities and performances of neonatal screening laboratories can be objectively evaluated by the quality specifications of acceptable imprecision.

The aim of the study was to promote the establishment and implementation of quality indicators (QIs) in clinical laboratories, catch up with the state of art, and provide preliminary quality specifications for established QIs.Clinical laboratories from different provinces in China were included in this QIs survey in 2015. All participants were asked to collect data related to QIs and complete QIs questionnaires. Defect percentages and sigma values were calculated for each QI. The 25th percentile, median, and the 75th percentile of defect percentages and TATs were calculated as optimum, desirable and minimum quality specifications. While 25th, median, and 75th of sigma values were calculated as minimum, desirable and optimum quality specifications, respectively.Five thousand seven hundred and fifty-three clinical laboratories from 28 provinces in China participated in this survey. Median defect percentages of pre-examination QIs varied largely from 0.01% (incorrect sample container) to 0.57% (blood culture contamination) with sigma values varied from 4.0σ to 5.1σ. Median defect percentages of examination phase QIs were all really high. The most common problem in examination phase was test uncovered by inter-laboratory comparison (86.67%). Defect percentages of critical values notification and timely critical values notification were all 0.00% (6.0σ). While the median of defect percentages of incorrect laboratory reports was only 0.01% (5.4σ).Improvements are needed in all phases of total testing process (TTP) in laboratories in China, especially in examination phase. More attention should be paid when microbiology specimens are collected and results are reported. Quality specifications can provide directions for laboratories to make effort for.

Evidence from allogeneic hematopoietic stem cell transplantation indicates a possible immune response against leukemia-associated antigens in patients with either acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). However, autologous immune responses are less evident. We have developed a method using sequential modulation of growth factors (SMGF) to generate specific anti-AML T-cells from primary cultures of mononuclear cells (MNCs) from patients with AML. This culture method induces greater degrees of antigen presentation by inducing dendritic cell (DC) differentiation of AML in the presence of autologous lymphocytes, which are then expanded by interleukin (IL)-2 and costimulatory molecule ligation. MNCs consisting of 92.3% +/- 5.1% AML blasts and 3.4% +/- 3.2% CD3+ T-cells were obtained from AML patients (n = 12) and cultured in AIM-V medium with IL-4 and recombinant granulocyte-monocyte colony-stimulating factor. Recombinant IL-2 was added on day 8. On day 21, culture conditions were changed to anti-CD3/anti-CD28 monoclonal antibodies and IL-2. By day 42, 354 +/- 182-fold CD3+ T-cell expansion had occurred. Cytotoxic T-lymphocyte assays demonstrated that these T-cells caused significant lysis of autologous leukemia cells and AML cell lines, but not of cells of other lineages, in an HLA class I-dependent manner. Specific Vbeta subgroups (Vbeta3, -7, and -12a), possibly representing T-cell clones specific to AML-specific antigens, were expanded in the cultures of cells from 3 AML patients. SMGF can be used to induce and expand autologous T-cells with HLA class I-dependent antileukemia potential from the peripheral blood of AML patients. Adoptive transfer of these expanded T-cells to patients is a possible therapeutic approach for further study. Biol Blood Marrow Transplant 2002;8(10):557-68.

Background This study aimed to investigate the status of internal quality control (IQC) for cardiac biomarkers from 2011 to 2016 so that we can have overall knowledge of the precision level of measurements in China and set appropriate precision specifications. Methods Internal quality control data of cardiac biomarkers, including creatinine kinase MB (CK-MB) (μg/L), CK-MB(U/L), myoglobin (Mb), cardiac troponin I (cTnI), cardiac troponin T (cTnT), and homocysteines (HCY), were collected by a web-based external quality assessment (EQA) system. Percentages of laboratories meeting five precision quality specifications for current coefficient of variations (CVs) were calculated. Then, appropriate precision specifications were chosen for these six analytes. Finally, the CVs and IQC practice were further analyzed with different grouping methods. Results The current CVs remained nearly constant for 6 years. cTnT had the highest pass rates every year against five specifications, whereas HCY had the lowest pass rates. Overall, most analytes had a satisfactory performance (pass rates >80%), except for HCY, if one-third TEa or the minimum specification were employed. When the optimal specification was applied, the performance of most analytes was frustrating (pass rates

Background Internal quality control (IQC) plays a key role in the evaluation of precision performance in clinical laboratories. This report aims to present precision status of thyroid hormones immunoassays from 2011 to 2016 in China. Methods Through Clinet-EQA reporting system, IQC information of Triiodothyronine and Thyroxine in the form of free and total (FT3, TT3, FT4, TT4), as well as Thyroid Stimulating Hormone (TSH) were collected from participant laboratories submitting IQC data in February, 2011-2016. For each analyte, current CVs were compared among different years and measurement systems. Percentages of laboratories meeting five allowable imprecision specifications (pass rates) were also calculated. Analysis of IQC practice was conducted to constitute a complete report. Results Current CVs were decreasing significantly but pass rates increasing only for FT3 during 6 years. FT3, TT3, FT4, and TT4 had the highest pass rates comparing with 1/3TEa imprecision specification but TSH had this comparing with minimum imprecision specification derived from biological variation. Constituent ratios of four mainstream measurement systems changed insignificantly. In 2016, precision performance of Abbott and Roche systems were better than Beckman and Siemens systems for all analytes except FT3 had Siemens also better than Beckman. Analysis of IQC practice demonstrated wide variation and great progress in aspects of IQC rules and control frequency. Conclusion With change of IQC practice, only FT3 had precision performance improved in 6 years. However, precision status of five analytes in China was still unsatisfying. Ongoing investigation and improvement of IQC have yet to be achieved.

ObjectivesTo investigate the status of neonatal screening in China in 2013.MethodAll Chinese neonatal screening laboratories were asked to submit information about the number of newborns screened and for which diseases, the rate of acceptable blood spots, and the time between sample collection and delivery to laboratories and reporting.ResultsOf the 202 laboratories, 194 (96%) submitted data. In 2013, 73.6% (142/193) of laboratories testing for phenylketonuria (PKU), 72.7% (141/194) for congenital hypothyroidism (CH), 58.9% (43/73) for glucose-6-phosphate dehydrogenase (G6PD) deficiency and 53.1% (34/64) for congenital adrenal hyperplasia (CAH) screened more than 30,000 newborns. The incidences of PKU, CH, G6PD deficiency, and CAH were 1:12189, 1:2281, 1:44 and 1:6084, respectively. The estimated coverage of screening for PKU, CH, G6PD deficiency, and CAH were 86.3 ∼ 87.5%, 87.9 ∼ 89.1%, 24.0 ∼ 25.0% and 18.9% ∼ 19.9%, respectively. The rates of acceptable blood spots were ≥98% in 161 (87.0%) of 185 laboratories. More than half the laboratories could not achieve a time from collection to reporting of 5 days.ConclusionNeonatal screening has developed rapidly in China but the biggest challenge is still to increase coverage and expand the screening disease panel across the entire country. More government support is needed to make neonatal screening more efficient.

Background This study aimed to evaluate whether the quality performance of clinical laboratories in China has been greatly improved and whether Internal Quality Control (IQC) practice of HbA1c has also been changed since National Center for Clinical Laboratories (NCCL) of China organized laboratories to report IQC data for HbA1c in 2012. Methods Internal Quality Control information of 306 External Quality Assessment (EQA) participant laboratories which kept reporting IQC data in February from 2012 to 2016 were collected by Web-based EQA system. Then percentages of laboratories meeting four different imprecision specifications for current coefficient of variations (CVs) of HbA1c measurements were calculated. Finally, we comprehensively analyzed analytical systems and IQC practice of HbA1c measurements. Results The current CVs of HbA1c tests have decreased significantly from 2012 to 2016. And percentages of laboratories meeting four imprecision specifications for CVs all showed the increasing tendency year by year. As for analytical system, 52.1% (159/306) laboratories changed their systems with the change in principle of assay. And many laboratories began to use cation exchange high-performance liquid chromatography (CE-HPLC) instead of Immunoturbidimetry, because CE-HPLC owed a lower intra-laboratory CVs. The data of IQC practice, such as IQC rules and frequency, also showed significant variability among years with overall tendency of meeting requirements. Conclusion The imprecision performance of HbA1c tests has been improved in these 5 years with the change in IQC practice, but it is still disappointing in China. Therefore, laboratories should actively find existing problems and take action to promote performance of HbA1c measurements.