Results of a Pilot External Quality Assessment Scheme for Genetic Testing of Newborns with Spinal Muscular Atrophy.

BACKGROUND: This study aims to evaluate the ability of laboratories to perform spinal muscular atrophy (SMA) genetic testing in newborns based on dried blood spot (DBS) samples, and to provide reference data and advance preparation for establishing the pilot external quality assessment (EQA) scheme for SMA genetic testing of newborns in China. METHODS: The pilot EQA scheme contents and evaluation principles of this project were designed by National Center for Clinical Laboratories (NCCL), National Health Commission. Two surveys were carried out in 2022, and 5 batches of blood spots were submitted to the participating laboratory each time. All participating laboratories conducted testing upon receiving samples, and test results were submitted to NCCL within the specified date. RESULTS: The return rates were 75.0% (21/28) and 95.2% (20/21) in the first and second surveys, respectively. The total return rate of the two examinations was 83.7% (41/49). Nineteen laboratories (19/21, 90.5%) had a full score passing on the first survey, while in the second survey twenty laboratories (20/20, 100%) scored full. CONCLUSIONS: This pilot EQA survey provides a preliminary understanding of the capability of SMA genetic testing for newborns across laboratories in China. A few laboratories had technical or operational problems in testing. It is, therefore, of importance to strengthen laboratory management and to improve testing capacity for the establishment of a national EQA scheme for newborn SMA genetic testing.

Result of a Pilot External Quality Assessment Scheme for Clinical Diagnosis of Inherited Metabolic Disorders in China.

BACKGROUND: We aimed to evaluate the diagnostic capabilities of Chinese laboratories for inherited metabolic disorders (IMDs) using gas chromatography-mass spectrometry (GC-MS) on urine samples. Meanwhile, based on the result of the pilot external quality assessment (EQA) scheme, we hope to establish a standardized and reliable procedure for future EQA practice. METHODS: We recruited laboratories that participated in the EQA of quantitative analysis of urinary organic acids with GC-MS before joining the surveys. In each survey, a set of five real urine samples was distributed to each participant. The participants should analyze the sample by GC-MS and report the "analytical result", "the most likely diagnosis", and "recommendation for further tests" to the NCCL before the deadline. RESULTS: A total of 21 laboratories participated in the scheme. The pass rates were 94.4% in 2020 and 89.5% in 2021. For all eight IMDs tested, the analytical proficiency rates ranged from 84.7% - 100%, and the interpretational performance rate ranged from 88.2% - 97.0%. The performance on hyperphenylalaninemia (HPA), 3-methylcrotonyl-CoA carboxylase deficiency (MCCD), and ethylmalonic encephalopathy (EE) samples were not satisfactory. CONCLUSIONS: In general, the participants of this pilot EQA scheme are equipped with the basic capability for qualitative organic acid analysis and interpretation of the results. Limited by the small size of laboratories and samples involved, this activity could not fully reflect the state of clinical practice of Chinese laboratories. NCCL will improve the EQA scheme and implement more EQA activities in the future.

Assessment and clinical utility of metagenomic next-generation sequencing for suspected lower respiratory tract infections.

OBJECTIVES: This study aims to compare the diagnostic efficacy of metagenomic next-generation sequencing (mNGS) to traditional diagnostic methods in patients with lower respiratory tract infections (LRTIs), elucidate the etiological spectrum of these infections, and explore the impact of mNGS on guiding antimicrobial therapy. METHODS: We retrospectively analyzed data from 128 patients admitted to the Respiratory Department of Anqing 116 Hospital between July 2022 and July 2023. All patients had undergone both mNGS and conventional microbiological techniques (CMT) for LRTI diagnosis. We assessed the diagnostic performance of these methods and examined the influence of mNGS on antimicrobial decision-making. RESULTS: Overall, mNGS demonstrated superior sensitivity (96.8%) and accuracy (96.8%) compared to CMT. For Mycobacterium tuberculosis detection, the accuracy and sensitivity of mNGS was 88.8% and 77.6%, which was lower than the 94.7% sensitivity of the T-spot test and the 79.6% sensitivity of CMT. In fungal pathogen detection, mNGS showed excellent sensitivity (90.5%), specificity (86.7%), and accuracy (88.0%). Bacteria were the predominant pathogens detected (75.34%), with Mycobacterium tuberculosis (41.74%), Streptococcus pneumoniae (21.74%), and Haemophilus influenzae (16.52%) being most prevalent. Bacterial infections were most common (62.10%), followed by fungal and mixed infections (17.74%). Of the 118 patients whose treatment regimens were adjusted based on mNGS results, 102 (86.5%) improved, 7 (5.9%) did not respond favorably, and follow-up was lost for 9 patients (7.6%). CONCLUSIONS: mNGS offers rapid and precise pathogen detection for patients with suspected LRTIs and shows considerable promise in diagnosing Mycobacterium tuberculosis and fungal infections. By broadening the pathogen spectrum and identifying polymicrobial infections, mNGS can significantly inform and refine antibiotic therapy.

Recycling alkali lignin-derived biochar with adsorbed cadmium into cost-effective CdS/C photocatalyst for methylene blue removal.

Cadmium (Cd)-enriched adsorbents wastes possess great environmental risk due to their large-scale accumulation and toxicity in the natural environment. Recycling spent Cd-enriched adsorbents into efficient catalysts for advanced applications could address the environmental issues and attain the carbon neutral goal. Herein, a facile strategy is developed for the first time to reutilize the alkali lignin (AL)-derived biochar (ALB) absorbed with Cd into cadmium sulphide (CdS)/C composite for the efficient methylene blue (MB) removal. The ALB is initially treated with Cd-containing solution, then the recycling ALB samples with adsorbed Cd are converted to the final CdS/C composite using NaS2 as the sulphurizing reagent for vulcanization reaction. The optimal ALB400 demonstrates a high adsorption capacity of 576.0 mg g-1 for Cd removal. Then the converted CdS/C composite shows an efficient MB removal efficiency of 94%. The photodegradation mechanism is mainly attributed to carbon components in the CdS/C composite as electron acceptor promoting the separation of photoelectrons/holes and slowing down the abrasion of CdS particles. The enhanced charge transfer and contact between the carrier and the active site thus improves the removal performance and reusability. This work not only develops a method for removing Cd from wastewater effectively and achieving the waste resource utilization but also further offers a significant guidance to use other kinds of spent heavy metal removal adsorbents for the construction of low-cost and high value-added functional materials.

A Dynamic Compartmental Model to Explore the Optimal Strategy of Varicella Vaccination: An Epidemiological Study in Jiangsu Province, China.

Varicella (chickenpox) is highly contagious among children and frequently breaks out in schools. In this study, we developed a dynamic compartment model to explore the optimal schedule for varicella vaccination in Jiangsu Province, China. A susceptible-infected-recovered (SIR) model was proposed to simulate the transmission of varicella in different age groups. The basic reproduction number was computed by the kinetic model, and the impact of three prevention factors was assessed through the global sensitivity analysis. Finally, the effect of various vaccination scenarios was qualitatively evaluated by numerical simulation. The estimated basic reproduction number was 1.831 ± 0.078, and the greatest contributor was the 5-10 year-old group (0.747 ± 0.042, 40.80%). Sensitivity analysis indicated that there was a strong negative correlation between the second dose vaccination coverage rate and basic reproduction number. In addition, we qualitatively found that the incidence would significantly decrease as the second dose vaccine coverage expands. The results suggest that two-dose varicella vaccination should be mandatory, and the optimal age of second dose vaccination is the 5-10 year-old group. Optimal vaccination time, wide vaccine coverage along with other measures, could enhance the effectiveness of prevention and control of varicella in China.

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.

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.

Environmental and economic performance of an integrated municipal solid waste treatment: A Chinese case study.

The application of integrated municipal solid waste (MSW) management has become increasingly common for the mitigation of the ever-growing MSW stream. However, despite their popularity across the globe, little is known about the performance of integrated MSW management (MSWM) plants. This study quantitively investigates the environmental and economic performance of an integrated MSW treatment center in the city of Horqin Left Rear Banner, Inner Mongolia Province, China, using a combined life cycle assessment (LCA) and life cycle costing (LCC) methodology. Results indicate that the integrated MSWM plant is sustainable in both environmental and economic aspects, as the life cycle environmental impacts and economic costs can be offset by substituting virgin products with recycled counterparts. Amongst the included treatments, MSW separation, brick making and plastic recycling are the greatest contributors to the total environmental burdens and economic expenses. LCC results demonstrate that the equipment cost, tax and other asset costs are the greatest contributors to the total costs of the plant. Sensitivity analysis confirms that the increasing source separation ratio results in the reduction of environmental burdens and economic expenses via the usage of biogas and photovoltaic power. Furthermore, we offer recommendations for the promotion of the environmental and economic sustainability of integrated MSW treatment facilities.

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.

Synergy of Nb Doping and Surface Alloy Enhanced on Water-Alkali Electrocatalytic Hydrogen Generation Performance in Ti-Based MXene.

Presented are the theoretical calculation and experimental studies of a Ti3C2T x MXene-based nanohybrid with simultaneous Nb doping and surface transition metal alloy modification. Guided by the density functional theory calculation, the Nb doping can move up the Fermi energy level to the conduction band, thus enhancing the electronic conductivity. Meanwhile, the surface modification by Ni/Co alloy can moderate the surface M-H affinity, which will further enhance the hydrogen evolution reaction (HER) activity. A series of Ni/Co alloy attached on Nb-doped Ti3C2T x MXene nanohybrids (denoted as NiCo@NTM) are successfully prepared. As expected, the Ni0.9Co0.1@ NTM nanohybrids present an extraordinary HER activity in alkaline solution, which only needs an overpotential (η) of 43.4 mV to reach the current density of 10 mA cm-2 in 1 m KOH solution and shows good stability. The performance of the Ni0.9Co0.1@ NTM nanohybrids is comparable to the commercial 10% Pt/C electrode (34.4 mV@10 mA cm-2) and is better than most state-of-the-art Pt-free HER catalysts. Inspired by the facile synthesis process and chemical versatility of both MXene and transition metal alloys, the nanohybrids reported here are promising non-noble metal electrocatalysts for water-alkali electrolysis.

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.

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.

Neonatal screening external quality assessment in China, 2014.

OBJECTIVE: To analyze the 2014 results of neonatal screening external quality assessment (EQA) performed by the Chinese National Centre for Clinical Laboratories. METHODS: EQA test panels consisting of five dried blood spots (three panels for phenylalanine (Phe) and thyroid stimulating hormone (TSH), two for glucose-6-phosphate dehydrogenase (G6PD) and 17-alpha-hydroxy progesterone (17-OHP)) were distributed to laboratories and the results collected and evaluated. To compare the correct recognition rates, chi-square test was used. RESULTS: Test results were received from 170 laboratories for Phe, 176 for TSH, 65 for G6PD and 65 for 17-OHP. The total number of effective quantitative and qualitative results of Phe, TSH, G6PD and 17-OHP were 2520 and 2370, 2605 and 2450, 645 and 530, 645 and 645, respectively. The overall correct recognition rates for qualitative tests of Phe, TSH, G6PD and 17-OHP were 99.79 %, 99.67 %, 93.40 % and 99.84 %, and the proportion of acceptable quantitative results were 94.48 %, 98.31 %, 84.65 % and 99.84 %, respectively. There were significant differences in the rates of acceptable quantitative results of the two measurement systems for Phe, TSH and G6PD (p<0.001); χ(2) test showed significant differences in correct recognition or acceptable rates among programmes (p<0.001). CONCLUSION: Most of the quantitative results were acceptable and the overall correct recognition rates in qualitative results approached 100%. Distributing more challenging samples and increasing the range of concentrations of EQA samples will improve standards in future assessments.

[Result survey analysis of prenatal chromosome karyotyping in an external quality assessment program].

OBJECTIVE: To analyze the results of prenatal karyotype of the external quality assessment program in 2013 in order to provide references and recommendations for improving the capability and performances of karyotype analysis of prenatal screening laboratories. METHODS: Five lots of quality control cell photos were sent to 500 laboratories. The participants were asked to decide whether the photos have demonstrated any abnormal karyotype and determine the abnormal type. The results should be submitted before the deadline and compared with the standard results to evaluate the performances of the laboratory. RESULTS: One hundred forty three laboratories have returned their karyotype results for the survey. The standard answers were 7,XX,+18, 46,X,i(X)(q10), 46,XY,i(21)(q10) or 46,XY,+21,der(21;21)(q10;q10), 46,XY and 47,XY,+21 in sequential order, which were used to estimate the score of each participant. The pass rates for five lots were 97.9%, 97.2%, 95.8%, 100.0% and 97.9%, respectively. The total pass rate was 97.7%. The error rates were 2.1%, 2.8%, 4.2%, 0 and 2.1%, respectively. The total error rate was 2.3%. CONCLUSION: Some laboratories did not correctly identify the abnormal karyotypes, while some could not determine the right type of karyotype. The external quality assessment program of prenatal diagnosis of karyotype analysis should be conducted annually in order to improve the capability and performances of karyotype analysis of prenatal screening laboratories.

[National external quality assessment and comparability of assays for tumor markers measurements].

OBJECTIVE: To evaluate the performance of tumor markers (TM) measurements in clinical laboratories by external quality assessment (EQA) and investigate the comparability of assays for TM. METHODS: Ten quality control sera specimens were distributed to 586 laboratories by global Express Mail Services (EMS) in March 2008 and tested twice with 5 specimens each time. Analytes were total prostate specific antigen (PSA), free PSA, carcinoembryonic antigen (CEA), alpha fetoprotein (AFP), human chorionic gonadotrophin (HCG), beta-HCG, carbohydrate antigen 19-9 (CA19-9), cancer antigen 15-3 (CA 15-3), cancer antigen 125 (CA125), beta-2-microglobulin and ferritin. The collected data were divided into peer groups according to analyzers or methods and the median of peer group was adopted as the target value (TV) separately after outlier removal. Two standard deviations of the median were set as the limit of difference. RESULTS: The first TM EQA results of 2008 showed that the pass percentage of all participating laboratories ranged from 87.3% (CA125) to 95.5% (beta-2-microglobulin). And the second batch ranged from 83.5% (HCG) to 94.0% (beta-2-microglobulin). The coefficient variances (CVs) of intra-group values determined by automatic analyzers were lesser than 15% for each test of every specimen. The CVs of radioimmunoassay (RIA) and enzyme-linked immunosorbent assay (ELISA) were over 20% and 50% respectively. The inter-group medians of 9 tests showed CVs>20% with HCG 13.4% and ferritin 15.7%. The CV of paired medians of some automatic analyzers was small and showed no statistical significance (all Z<1.890, all P>0.05). CONCLUSION: The analytical performance of automatic analyzers is superior to RIA and ELISA. There is an excellent comparability within automatic analyzers for TM measurements and a lack of comparability within RIA and ELISA. Noncomparability is found in over 80% of TM assays.

[Relationship between computed tomography coronary angiography and adenosine stress myocardial perfusion imaging for the assessment of coronary artery disease].

OBJECTIVE: To compare the accuracy of computed tomography coronary angiography (CTCA) and adenosine stress myocardial perfusion imaging in the diagnosis of coronary artery disease (CAD) and discuss their relationship. METHODS: Fifty-six patients, suspected or diagnosed as CAD, were performed with CTCA, MPI and coronary angiography (CAG) within 3 weeks. They were divided into 3 groups: no CAD, no obstructive CAD (coronary artery stenosis < 70%) and obstructive CAD (coronary artery stenosis > or = 70%). RESULTS: 5 patients were diagnosed as no CAD. 19 patients were diagnosed as no obstructive CAD and 32 patients were diagnosed as obstructive CAD by CTCA. While adenosine stress MPI suggested 26 patients normal, 18 patients had IPD and 29 patients had RPD. The sensibility, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTCA were 100%, 55.6%, 92.2% and 100% versus 78.6%, 71.4%, 73.3% and 76.9% respectively for adenosine stress MPI. CONCLUSION: CTCA and adenosine stress MPI provide different and complementary information on CAD, anatomical versus functional. As compared with CAG, CTCA has a high accuracy of detecting CAD.

Robust and traditional statistical methods in the establishment of immunoglobulin E target values in external quality assessment program.

BACKGROUND: In an EQA scheme, peer group mean is conventionally regarded as the target after removing values exceeding the mean+/-3SD. However, this computation fails if there are some outliers. METHODS: The outliers in each original data set were separately deleted by traditional and robust statistical methods. The data distributions of original and trimmed data sets were separately tested by Shapiro-Wilks or Kolmogorov-Smirnov Z test. The means of peer groups were used to set IgE targets. The difference between targets set by both methods was tested by 1-sample t test. RESULTS: The original data sets were not all Gaussian distributed. After deletion of outliers using robust statistical method, the modified data sets of all tested groups were normally distributed. IgE targets established by robust and traditional methods were significantly different in some groups. The incompatible IgE targets derived all from the original and trimmed data sets which were not Gaussian distributed. CONCLUSIONS: The premise for choosing a traditional method to delete outliers and using peer group means as targets was that the data sets must be Gaussian distributed. The reasons that caused the targets to be incompatible possibly were the 2 rules to be broken. Robust statistical method was used for deletion of outliers due to the distorted distribution.