The impact of the digital economy on high-quality agricultural development--Based on the regulatory effects of financial development.

The digital economy, as a new economic form with high information density, provides a new driving force for the realization of high-quality agricultural development. Panel data of 31 provinces in China from 2011 to 2020 were selected for analysis. The static panel data interaction effect model and panel threshold model were used to verify the nonlinear influence mechanism and heterogeneity of financial development in the process of the digital economy affecting high-quality agricultural development. The findings are as follows. (1) During the study period, the high-quality development of China's agriculture showed a steady upward trend; however, the regional differences were significant, and the eastern part was larger than the central and western part. (2) The digital economy can promote high-quality agricultural development. (3) The digital economy has a double threshold effect in the process of affecting high-quality agricultural development, which depends on the level of financial development. When the threshold is exceeded, the digital economy has a more significant promoting effect on high-quality agricultural development. (4) The impact of the digital economy on high-quality agricultural development is heterogeneous. From the perspective of different regions, the impact effect is greatest in the eastern region, while the effect is smaller in the central and western regions. From different resource endowments, the positive impact effect is greatest in the major grain-selling areas, followed by the major grain producing areas, but the positive digital economy driving effect is not significant in the balance of production and sales areas. Finally, three policy suggestions are proposed. First, the Chinese government should increase investments in and support for digital technology to promote the integration of the digital economy and agriculture. Second, the Chinese government should promote the development of digital inclusive finance in areas with financial development below the threshold. Third, different regions should implement differentiated digital economies to promote high-quality agricultural development.

Tumor-Agnostic Approvals: Insights and Practical Considerations.

Since the first approval of a tumor-agnostic indication in 2017, a total of seven tumor-agnostic indications involving six drugs have received approval from the FDA. In this paper, the master protocol subteam of the Statistical Methods in Oncology Scientific Working Group, Biopharmaceutical Session, American Statistical Association, provides a comprehensive summary of these seven tumor-agnostic approvals, describing their mechanisms of action; biomarker prevalence; study design; companion diagnostics; regulatory aspects, including comparisons of global regulatory requirements; and health technology assessment approval. Also discussed are practical considerations relating to the regulatory approval of tumor-agnostic indications, specifically (i) recommendations for the design stage to mitigate the risk that exceptions may occur if a treatment is initially hypothesized to be effective for all tumor types and (ii) because drug development continues after approval of a tumor-agnostic indication, recommendations for further development of tumor-specific indications in first-line patients in the setting of a randomized confirmatory basket trial, acknowledging the challenges in this area. These recommendations and practical considerations may provide insights for the future development of drugs for tumor-agnostic indications.

Effectiveness and cost-effectiveness of six GLP-1RAs for treatment of Chinese type 2 diabetes mellitus patients that inadequately controlled on metformin: a micro-simulation model.

Objective: To systematically estimate and compare the effectiveness and cost-effectiveness of the glucagon-like peptide-1 receptor agonists (GLP-1RAs) approved in China and to quantify the relationship between the burden of diabetic comorbidities and glycosylated hemoglobin (HbA1c) or body mass index (BMI). Methods: To estimate the costs (US dollars, USD) and quality-adjusted life years (QALY) for six GLP-1RAs (exenatide, loxenatide, lixisenatide, dulaglutide, semaglutide, and liraglutide) combined with metformin in the treatment of patients with type 2 diabetes mellitus (T2DM) which is inadequately controlled on metformin from the Chinese healthcare system perspective, a discrete event microsimulation cost-effectiveness model based on the Chinese Hong Kong Integrated Modeling and Evaluation (CHIME) simulation model was developed. A cohort of 30,000 Chinese patients was established, and one-way sensitivity analysis and probabilistic sensitivity analysis (PSA) with 50,000 iterations were conducted considering parameter uncertainty. Scenario analysis was conducted considering the impacts of research time limits. A network meta-analysis was conducted to compare the effects of six GLP-1RAs on HbA1c, BMI, systolic blood pressure, and diastolic blood pressure. The incremental net monetary benefit (INMB) between therapies was used to evaluate the cost-effectiveness. China's per capita GDP in 2021 was used as the willingness-to-pay threshold. A generalized linear model was used to quantify the relationship between the burden of diabetic comorbidities and HbA1c or BMI. Results: During a lifetime, the cost for a patient ranged from USD 42,092 with loxenatide to USD 47,026 with liraglutide, while the QALY gained ranged from 12.50 with dulaglutide to 12.65 with loxenatide. Compared to exenatide, the INMB of each drug from highest to lowest were: loxenatide (USD 1,124), dulaglutide (USD -1,418), lixisenatide (USD -1,713), semaglutide (USD -4,298), and liraglutide (USD -4,672). Loxenatide was better than the other GLP-1RAs in the base-case analysis. Sensitivity and scenario analysis results were consistent with the base-case analysis. Overall, the price of GLP-1RAs most affected the results. Medications with effective control of HbA1c or BMI were associated with a significantly smaller disease burden (p < 0.05). Conclusion: Loxenatide combined with metformin was identified as the most economical choice, while the long-term health benefits of patients taking the six GLP-1RAs are approximate.

Human Resource Planning and Configuration Based on Machine Learning.

Human resources are the core resources of an enterprise, and the demand forecasting plays a vital role in the allocation and optimization of human resources. Starting from the basic concepts of human resource forecasting, this paper employs the backpropagation neural network (BPNN) and radial basis function neural network (RBFNN) to analyze human resource needs and determine the key elements of the company's human resource allocation through predictive models. With historical data as reference, the forecast value of current human resource demand is obtained through the two types of neural networks. Based on the prediction results, the company managers can carry out targeted human resource planning and allocation to improve the efficiency of enterprise operations. In the experiment, the actual human resource data of a certain company are used as the experimental basic samples to train and test the two types of machine learning tools. The experimental results show that the method proposed in this paper can effectively predict the number of personnel required and can support the planning and allocation of human resources.

Global, regional, and national burden of kidney, bladder, and prostate cancers and their attributable risk factors, 1990-2019.

BACKGROUND: The burden of kidney, bladder, and prostate cancers has changed in recent decades. This study aims to investigate the global and regional burden of, and attributable risk factors for genitourinary cancers during the past 30 years. METHODS: We extracted data of kidney, bladder, and prostate cancers from the Global Burden of Disease 2019 database, including incidence, mortality, disability-adjusted life-years (DALYs), and attributable risk factors from 1990 to 2019. Estimated annual percentage changes (EAPC) were calculated to assess the changes in age-standardized incidence rate, age-standardized mortality rate (ASMR), and age-standardized DALYs rate (ASDR). The associations between cancers burden and socio-demographic index (SDI) were also analyzed. RESULTS: Compared with 1990, the global incident cases in 2019 were higher by 154.78%, 123.34%, and 169.11% for kidney, bladder, and prostate cancers, respectively. During the 30-year study period, there was a downward trend in ASMR and ASDR for bladder cancer (EAPC = - 0.68 and - 0.83, respectively) and prostate cancer (EAPC = - 0.75 and - 0.71, respectively), but an upward trend for kidney cancer (EAPC = 0.35 and 0.12, respectively). Regions and countries with higher SDI had higher incidence, mortality, and DALYs for all three types of cancers. The burden of bladder and prostate cancers was mainly distributed among older men, whereas the burden of kidney cancer increased among middle-aged men. Smoking related mortality and DALYs decreased, but high body mass index (BMI) and high fasting plasma glucose (FPG) related mortality and DALYs increased among kidney, bladder, and prostate cancers during the study period. CONCLUSIONS: Kidney, bladder, and prostate cancers remain major global public health challenges, but with distinct trend for different disease entity across different regions and socioeconomic status. More proactive intervention strategies, at both the administrative and academic levels, based on the dynamic changes, are needed.

Association of food expenditure with life expectancy in the United States, 2001-2014.

OBJECTIVES: A healthy diet is associated with reduced risk for premature death; however, data on the association between food expenditure and life expectancy are scarce. The aim of this study was to determine the association of expenditure on food groups with life expectancy in men and women. METHODS: This study used data from 1548 counties, representing >90% of the population of the United States from 2001 through the end of 2014. Multivariable adjusted Bayesian generalized linear models were used to assess the association of county-level expenditure on nine groups of individual food and combined healthy and unhealthy foods, and a constructed healthy diet score with life expectancy at 40 y of age by sex. RESULTS: A 1-unit increase in the healthy diet score based on food expenditure was associated with a 0.07 y (95% confidence interval [CI], 0.05-0.10), 0.04 y (95% CI, 0.02-0.07), and 0.06 y (95% CI, 0.04-0.08) increase in county-level life expectancy among men alone, women alone, and men and women combined, respectively. Increasing expenditure on whole grains (estimate of per 1% increase 0.07; 95% CI, 0.03-0.11), fresh fruit and vegetables (0.06; 95% CI, 0.02-0.09), and dairy products (0.05; 95% CI, 0.03-0.07), as well as reducing expenditure on sugar-sweetened beverages (-0.02; 95% CI, -0.04 to -0.01) and processed red meat (-0.05; 95% CI, -0.08 to -0.02) showed a positive association with increased county-level life expectancy. CONCLUSIONS: These findings may inform a nutritional measure against premature death and stagnation of increase in life expectancy.

Analysis of External Quality Assessment of Maternal Serum Prenatal Screening for Down Syndrome in the First Trimester in China.

BACKGROUND: We analyzed the 2019 external quality assessment (EQA) results to evaluate the analytical performance of maternal serum prenatal screening for Down Syndrome (DS) in the first trimester in China. METHODS: In each round, five lyophilized EQA samples with detailed clinical information were distributed to participants and used to test the concentration of human chorionic gonadotropin free beta subunits (free ß-HCG) and pregnancy-associated plasma protein-A (PAPP-A) to calculate the risk value of DS. The robust coefficient of variability (CV) was calculated or test results for free ß-HCG and PAPP-A using analytes and major measurement platforms. For DS risk values, the robust CV was calculated using a professional calculation platform. Failed EQA results were analyzed using serum marker testing results and DS risk values. RESULTS: EQA results were collected from 242 laboratories in round 1 and 239 laboratories in round 2. Total acceptable rates of testing results for free ß-HCG and PAPP-A ranged from 95.04% to 97.91%. Overall acceptable rates of DS risk values ranged from 97.52% to 97.90%. The proportion of laboratories exhibiting satisfactory performance was higher in round 2 than in round 1 for serum marker testing results and DS risk values. The robust CV for risk values for each sample were significantly higher than those of serum markers. Three EQA result failure types were found, including result reporting errors, serum marker concentration testing errors, and DS risk calculation errors. CONCLUSIONS: The analytical performance of maternal serum prenatal screening for DS in the first trimester in China can be improved further.

Genetically predicted education attainment in relation to somatic and mental health.

A deeper understanding of the causal links from education level to health outcomes may shed a light for disease prevention. In the present Mendelian randomization study, we found that genetically higher education level was associated with lower risk of major mental disorders and most somatic diseases, independent of intelligence. Higher education level adjusted for intelligence was associated with lower risk of suicide attempts, insomnia, major depressive disorder, heart failure, stroke, coronary artery disease, lung cancer, breast cancer, type 2 diabetes and rheumatoid arthritis but with higher risk of obsessive-compulsive disorder, anorexia nervosa, anxiety, bipolar disorder and prostate cancer. Higher education level was associated with reduced obesity and smoking, which mediated quite an extent of the associations between education level and health outcomes. These findings emphasize the importance of education to reduce the burden of common diseases.

National Program for External Quality Assessment of Chinese Newborn Screening Laboratories.

OBJECTIVES: To analyze the coefficient of variation (CV) of external quality assessment (EQA) in Chinese newborn screening (NBS) laboratories. METHOD: EQA's robust CV was analyzed by the Clinet-EQA evaluation system. RESULTS: Participating laboratories of the EQA program increased annually. There was more than a 11-fold increase in phenylalanine (Phe) and thyroid stimulating hormone (TSH). It has shown a declining robust CV, which has tended to level off in recent years. The interquartile range (IQR) of Phe and TSH's robust CV has decreased from 15.5% to 1.5% and from 22.8% to 1.8%, respectively. Compared to bacterial inhibition assay (BIA), the robust CV of Phe has been shown to be relatively reduced in the fluorescence assay and quantitative enzymatic assay (QEA). The robust CV by ELISA was relatively unstable compared to DELFIA and FEIA. In addition, the robust CVs of glucose-6-phosphate dehydrogenase (G6PD) and 17-alpha-hydroxy progesterone (17-OHP) by Genetic Screening Processor (GSP) were lower than other systems. The median of robust CV by non-derivatized MS/MS (Fenghua) in Phe and free carnitine were around 2.2-4.7% and 2.6-5.2%. CONCLUSION: Neonatal screening has developed rapidly in China and the majority of participant laboratories had satisfactory performance for the quantitative results.

Exploration of the Misfolding Mechanism of Transthyretin Monomer: Insights from Hybrid-Resolution Simulations and Markov State Model Analysis.

Misfolding and aggregation of transthyretin (TTR) is widely known to be responsible for a progressive systemic disorder called amyloid transthyretin (ATTR) amyloidosis. Studies suggest that TTR aggregation is initiated by a rate-limiting dissociation of the homo-tetramer into its monomers, which can rapidly misfold and self-assemble into amyloid fibril. Thus, exploring conformational change involved in TTR monomer misfolding is of vital importance for understanding the pathogenesis of ATTR amyloidosis. In this work, microsecond timescale hybrid-resolution molecular dynamics (MD) simulations combined with Markov state model (MSM) analysis were performed to investigate the misfolding mechanism of the TTR monomer. The results indicate that a macrostate with partially unfolded conformations may serve as the misfolded state of the TTR monomer. This misfolded state was extremely stable with a very large equilibrium probability of about 85.28%. With secondary structure analysis, we found the DAGH sheet in this state to be significantly destroyed. The CBEF sheet was relatively stable and sheet structure was maintained. However, the F-strand in this sheet was likely to move away from E-strand and reform a new ß-sheet with the H-strand. This observation is consistent with experimental finding that F and H strands in the outer edge drive the misfolding of TTR. Finally, transition pathways from a near native state to this misfolded macrostate showed that the conformational transition can occur either through a native-like ß-sheet intermediates or through partially unfolded intermediates, while the later appears to be the main pathway. As a whole, we identified a potential misfolded state of the TTR monomer and elucidated the misfolding pathway for its conformational transition. This work can provide a valuable theoretical basis for understanding of TTR aggregation and the pathogenesis of ATTR amyloidosis at the atomic level.

PM2.5 Pollution: Health and Economic Effect Assessment Based on a Recursive Dynamic Computable General Equilibrium Model.

At present particulate matter (PM2.5) pollution represents a serious threat to the public health and the national economic system in China. This paper optimizes the whitening coefficient in a grey Markov model by a genetic algorithm, predicts the concentration of fine particulate matter (PM2.5), and then quantifies the health effects of PM2.5 pollution by utilizing the predicted concentration, computable general equilibrium (CGE), and a carefully designed exposure-response model. Further, the authors establish a social accounting matrix (SAM), calibrate the parameter values in the CGE model, and construct a recursive dynamic CGE model under closed economy conditions to assess the long-term economic losses incurred by PM2.5 pollution. Subsequently, an empirical analysis was conducted for the Beijing area: Despite the reduced concentration trend, PM2.5 pollution continued to cause serious damage to human health and the economic system from 2013 to 2020, as illustrated by various facts, including: (1) the estimated premature deaths and individuals suffering haze pollution-related diseases are 156,588 (95% confidence intervals (CI): 43,335-248,914)) and six million, respectively; and (2) the accumulated labor loss and the medical expenditure negatively impact the regional gross domestic product, with an estimated loss of 3062.63 (95% CI: 1,168.77-4671.13) million RMB. These findings can provide useful information for governmental agencies to formulate relevant environmental policies and for communities to promote prevention and rescue strategies.

External Quality Assessment Program for Newborn Screening of Acylcarnitine in China, 2018.

BACKGROUND: The aim of this study was to analyze the 2018 external quality assessment (EQA) results of newborn screening by MS/MS of acylcarnitine by Chinese National Center for Clinical Laboratories and to determine 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 (2) test was used to compare the correct recognition rates. RESULTS: EQA results were collected from 150 laboratories for 15 different acylcarnitines between C0 - C18. The overall acceptable rates of the qualitative results were between 81.21% and 96.67%, and the proportion of acceptable quantitative results were between 78.38% and 93.24%. There were significant differences in the rates of acceptable quantitative results among different items and between the four methods. CONCLUSIONS: Most of the participant laboratories had satisfactory performance for the quantitative results in this EQA scheme. But for qualitative assessment, a laboratory should re-evaluate and validate their reference intervals on a regular basis to improve the consistency of clinical assessment.

External Quality Assessment Program for Newborn Screening of Amino Acids in China.

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.

Quality assessment of interpretative commenting and competency comparison of comment providers in China.

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.

Analysis and evaluation of the external quality assessment results of quality indicators in laboratory medicine all over China from 2015 to 2018.

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.

Periodic benefit-risk assessment using Bayesian stochastic multi-criteria acceptability analysis.

Benefit-risk (BR) assessment is essential to ensure the best decisions are made for a medical product in the clinical development process, regulatory marketing authorization, post-market surveillance, and coverage and reimbursement decisions. One challenge of BR assessment in practice is that the benefit and risk profile may keep evolving while new evidence is accumulating. Regulators and the International Conference on Harmonization (ICH) recommend performing periodic benefit-risk evaluation report (PBRER) through the product's lifecycle. In this paper, we propose a general statistical framework for periodic benefit-risk assessment, in which Bayesian meta-analysis and stochastic multi-criteria acceptability analysis (SMAA) will be combined to synthesize the accumulating evidence. The proposed approach allows us to compare the acceptability of different drugs dynamically and effectively and accounts for the uncertainty of clinical measurements and imprecise or incomplete preference information of decision makers. We apply our approaches to two real examples in a post-hoc way for illustration purpose. The proposed method may easily be modified for other pre and post market settings, and thus be an important complement to the current structured benefit-risk assessment (sBRA) framework to improve the transparent and consistency of the decision-making process.

Genetic predisposition to lung cancer: comprehensive literature integration, meta-analysis, and multiple evidence assessment of candidate-gene association studies.

More than 1000 candidate-gene association studies on genetic susceptibility to lung cancer have been published over the last two decades but with few consensuses for the likely culprits. We conducted a comprehensive review, meta-analysis and evidence strength evaluation of published candidate-gene association studies in lung cancer up to November 1, 2015. The epidemiological credibility of cumulative evidence was assessed using the Venice criteria. A total of 1018 publications with 2910 genetic variants in 754 different genes or chromosomal loci were eligible for inclusion. Main meta-analyses were performed on 246 variants in 138 different genes. Twenty-two variants from 21 genes (APEX1 rs1130409 and rs1760944, ATM rs664677, AXIN2 rs2240308, CHRNA3 rs6495309, CHRNA5 rs16969968, CLPTM1L rs402710, CXCR2 rs1126579, CYP1A1 rs4646903, CYP2E1 rs6413432, ERCC1 rs11615, ERCC2 rs13181, FGFR4 rs351855, HYKK rs931794, MIR146A rs2910164, MIR196A2 rs11614913, OGG1 rs1052133, PON1 rs662, REV3L rs462779, SOD2 rs4880, TERT rs2736098, and TP53 rs1042522) showed significant associations with lung cancer susceptibility with strong cumulative epidemiological evidence. No significant associations with lung cancer risk were found for other 150 variants in 98 genes; however, seven variants demonstrated strong cumulative evidence. Our findings provided the most updated summary of genetic risk effects on lung cancer and would help inform future research direction.

External Quality Assessment of First-Trimester Prenatal Biochemical Screening in China.

BACKGROUND: Free ß subunit of human chorionic gonadotropin (free ß-hCG) and pregnancy-associated plasma protein A (PAPP-A) are two important biomarkers in first-trimester prenatal screening. This study intended to reflect their analytical performance in clinical laboratories and main platforms of the 2015 External Quality Assessment (EQA) scheme for the first-trimester biochemical screening in China. METHODS: Ten lyophilized EQA samples, divided into two sets and analyzed in two cycles 20151 and 20152, were distributed to each participant in 2015. Satisfactory performance was defined as scores more than 80 of acceptable results within the evaluation criterion of ± 30%. The robust coefficient of variability (CV) of each sample was calculated by analytes and mainstream platforms. The chi-square (2) test and the Mann-Whitney test were respectively used to compare the acceptable performance and the robust CV between two analytes, as well as two mainstream platforms. RESULTS: A total of 142 laboratories were enrolled in this EQA scheme. For free ß-hCG and PAPP-A, the number of effective results were 1330 and 1355, respectively, and the overall acceptable rates of results were 95.11% and 92.32%, respectively. For cycle 20151 and 20152, the acceptable rates were respectively 92.59% and 96.19% for free ß-hCG and 89.78% and 94.78% for PAPP-A. The 2 test showed acceptable performance differed significantly between the two analytes, as well as two platforms for PAPP-A. Significant difference of the robust CV in different analytes and platforms was demonstrated by Mann-Whitney test. CONCLUSIONS: Greater than 92% of results were acceptable. However, continuous improvement and further research of this EQA scheme is in process.

Status of External Quality Assessment on Tumor Markers in China.

BACKGROUND: The nationwide external quality assessment (EQA) of tumor markers in China has been launched for years. The quality of the performance of Chinese clinical laboratories on tumor markers is partly reflected through analysis of EQA results. This report presents an 8-year EQA result of the six most common tumor markers from 2006 to 2013. METHODS: Ten freeze-dried EQA samples were distributed to participants every year. Satisfactory performance was defined as scores of more than 80% of acceptable responses with the evaluation criterion of ± 25%. The robust coefficient of variability (CV) between laboratories and percentage difference against the target value of each sample were also calculated by year. RESULTS: A total number of 1154 laboratories submitted results in 2013, which was more than threefold of 2006. The proportion of laboratories with satisfactory performance showed an overall rising trend over the years and was up to 95% for the second survey in 2013. The overall decrease of robust CV was observed for all analytes including alpha fetoprotein (AFP), carcinoembryonic antigen (CEA), total prostate specific antigen (t-PSA), cancer antigen 125 (CA 125), cancer antigen 15-3 (CA 15-3), and cancer antigen 19-9 (CA 19-9) except for CEA, which exhibited a rise followed by a flat trend. The percentage difference narrowed gradually and was less than 2% in 2013. CONCLUSIONS: The 8-year EQA results showed a significant enhancement of degree of harmonization of tumor markers in China. However, standardization among various testing systems and improvement of harmonization has yet to be achieved.