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Resumen La participación en programas de evaluación externa de la calidad (PEEC) dirigidos al diagnóstico de enfermedades genéticas permite obtener una medida objetiva del desempeño técnico y analítico de los laboratorios y es un requisito para la acreditación de los laboratorios clínicos bajo la norma ISO 15189. El objetivo de este estudio fue evaluar retrospectivamente el desempeño en los esquemas EMQN (European Molecular Genetics Quality Network) y CF Network (Cystic Fibrosis European Network) en el período 2014-2022. Se participó en un total de 88 esquemas. Se recolectó la información de nuestros puntajes y las medias de los laboratorios participantes en las categorías genotipificación, interpretación y exactitud de la información del paciente/informe. Se informó en forma completa el 90,9% (n=80) de los esquemas. El desempeño en genotipificación mostró puntajes superiores a la media en el 89,3% de los esquemas; 0,8% de los informes correspondieron a falsos negativos. En interpretación, el 66,7% de los esquemas evidenció un desempeño superior a la media y el 33,3% debajo de la media. La exactitud de la información del paciente/informe presentó puntajes superiores a la media en el 97,6% de los esquemas. Se observó una diferencia estadísticamente significativa en el porcentaje de esquemas con puntaje por encima de la media en el año 2022 (10/12 esquemas) respecto al año 2014 (1/6 esquemas) en la categoría interpretación (p=0,0128). En conclusión, la participación regular en PEEC tuvo impacto positivo en la calidad de los estudios y permite realizar mejoras continuas a partir de las recomendaciones sugeridas por estos programas.
Abstract Participation in external quality assessment programmes focused on rare genetic diseases makes it possible to assess the laboratory technical and analytical performance and it is a prerequisite for accreditation according to ISO 15189. The objective of this study was to perform a retrospective evaluation of our performance in the EMQN (European Molecular Genetics Quality Network) and the CF Network (Cystic Fibrosis European Network) programmes in the 2014-2022 period. The laboratory performance on genotyping, interpretation and clerical accuracy and patient identifiers in a total of 88 schemes were assessed. The information of our scores and the mean scores of all participating laboratories in the three categories were collected. A total of 90.9% of the schemes were fully completed. The performance in genotyping showed scores above the mean scores in 89.3% of the schemes; 0.8% of the reports correspond to false negative results. Regarding interpretation category, 66.7% of the schemes presented scores above the mean scores and 33.3% below the mean scores. The clerical accuracy and patient identifiers were above the mean scores in 97.6% of the schemes. A statistically significant difference in the percentage of schemes with a score above the mean for the interpretation category in the year 2022 (10/12 schemes) was observed compared to the year 2014 (1/6 schemes) (p=0.0128). In conclusion, regular participation in external quality assessment programmes had a positive impact on the quality of the studies and allows for continuous improvements based on the recommendations suggested by these programmes.
Resumo A participação em programas de avaliação externa da qualidade (PEECs) voltados para o diagnóstico de doenças genéticas permite obter uma mensuração objetiva do desempenho técnico e analítico dos laboratórios e é requisito para a acreditação dos laboratórios clínicos sob a norma ISO 15189. O objetivo desse estudo foi avaliar retrospectivamente o desempenho nos esquemas EMQN (European Molecular Genetics Quality Network) e CF Network (Cystic Fibrosis European Network) no período 2014-2022. Participou-se em um total de 88 esquemas. Foram coletadas informações de nossos escores e das médias dos laboratórios participantes nas categorias genotipagem, interpretação e precisão da informação do paciente/laudo. 90,9% (n=80) dos esquemas foram informados em sua totalidade. O desempenho na genotipagem apresentou escores acima da média em 89,3% dos esquemas; 0,8% dos laudos corresponderam a falsos negativos. Na interpretação, 66,7% dos esquemas apresentaram desempenho acima da média e 33,3% abaixo da média. A precisão das informações do paciente/laudo apresentou escores acima da média em 97,6% dos esquemas. Observou-se diferença estatisticamente significativa no percentual de esquemas com pontuação acima da média no ano de 2022 (10/12 esquemas) em relação ao ano de 2014 (1/6 esquemas) na categoria interpretação (p=0,0128). Em conclusão, a participação regular em PEECs teve um impacto positivo na qualidade dos estudos e permite fazer melhorias contínuas com base nas recomendações sugeridas por esses programas.
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SUMMARY In the emergency care of cancer patients, in addition to cancer-related factors, two aspects influence the outcome: (1) where the patient is treated and (2) who will perform the surgery. In Brazil, a significant proportion of patients with surgical oncological emergencies will be operated on in general hospitals by surgeons without training in oncological surgery. OBJECTIVE: The objective was to discuss quality indicators and propose the creation of an urgent oncological surgery advanced life support course. METHODS: Review of articles on the topic. RESULTS: Generally, nonelective resections are associated with higher rates of morbidity and mortality, as well as lower rates of cancer-specific survival. In comparison to elective procedures, the reduced number of harvested lymph nodes and the higher rate of positive margins suggest a compromised degree of radicality in the emergency scenario. CONCLUSION: Among modifiable factors is the training of the emergency surgeon. Enhancing the practice of oncological surgery in emergency settings constitutes a formidable undertaking that entails collaboration across various medical specialties and warrants endorsement and support from medical societies and educational institutions. It is time to establish a national registry encompassing oncological emergencies, develop quality indicators tailored to the national context, and foster the establishment of specialized training programs aimed at enhancing the proficiency of physicians serving in emergency services catering to cancer patients.
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Resumo O objetivo deste estudo foi avaliar a tendência temporal da qualidade da atenção à saúde da criança na consulta da primeira semana de vida no nível da Atenção Primária à Saúde, segundo características dos municípios, do processo de trabalho das equipes e das usuárias responsáveis pelas crianças. Foram realizadas análises transversais com dados dos três ciclos do Programa Nacional de Melhoria do Acesso e da Qualidade (PMAQ) (2012, 2014 e 2018). Usuárias adultas com filhos de até dois anos foram entrevistadas. O desfecho foi a "boa qualidade da atenção à saúde na primeira semana de vida". Foram realizadas análises descritivas e de tendência temporal por meio de regressão de mínimos quadrados ponderados por variância. A frequência de boa qualidade na consulta da primeira semana de vida foi 47,9% (IC95% 46,6-49,3) em 2012, 52,5% (IC95% 51,3-53,7) em 2014 e 53,3% (IC95% 52,2-54,4) em 2018, com um aumento anual de 0,73 ponto percentual (p<0,001). O aumento anual foi maior na região Nordeste (2,06 pp) e com IDH muito baixo/baixo (1,48 pp) e com 100% de cobertura de ESF (0,98 pp). Ao longo dos três ciclos do PMAQ-AB houve uma evolução favorável na frequência da boa qualidade na atenção à saúde na primeira semana de vida.
Abstract The aim of this study was to assess temporal trends in the quality of health care during the first-week child check-up in primary care services stratified by municipal, health team and maternal characteristics. We conducted a cross-sectional study using data from the three cycles of the National Program for the Improvement of Access and Quality (PMAQ) (2012, 2014 and 2018). Adult service users with children aged up to 2 were interviewed. The outcome was "good quality health care in the first week of life". Descriptive and time trend analyses were performed using variance-weighted least squares regression. The frequency of good quality care during the first-week check-up was 47.9% (95%CI 46.6-49.3) in 2012, 52.5% (95%CI 51.3-53.7) in 2014 and 53.3% (95%CI 52.2-54.4) in 2018, with an annual increase of 0.73 pp (p<0.001). The annual increase was greater in the Northeast (2.06 pp) and in municipalities with very low/low HDI (1.48 pp) and 100% family health strategy coverage (0.98 pp). Trends in the frequency of good quality health care during the first-week child check-up were favorable.
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The taste of oral dosage forms has become a critical factor affecting the drug compliance and adherence to the treatment, and clinical application of the drug product may seriously restricted due to its bad taste. On the basis of the statement for the basic principle and specific performance of existing instruments, the application progress of electronic tongue on drug taste evaluation is addressed in detail. In view of its objective, fatigue-free, less harmful and accurate advantages, electronic tongue has been widely and meaningfully applied in the aspects of bitterness masking, and quality assessment and assurance of drug products. In addition, the reasons limiting the popularization of electronic tongue are mentioned in the paper, and some suggestions might be useful to enlarge the further application in the future.
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Objective:To analyze the implementation of the external quality assessment plan for quality indicators of clinical laboratories in China from 2016 to 2021, as well as that of the external quality assessment of 15 quality indicators in clinical laboratories, in order to provide reference for quality management of clinical laboratory specialties.Methods:The research data was collected from the external quality assessment plan for quality indicators, which was conducted by the National Center for Clinical Laboratories joining the clinical laboratory centers of 31 provinces (autonomous regions and municipalities directly). The essential information reported by each participating clinical laboratory from 2016 to 2021 and the external quality assessment data of 15 quality indicators in clinical laboratories were collected, followed by a descriptive analysis on the number of participating laboratories and the number of returns for each indicator. Median representation was used for the external quality assessment data of 15 quality indicators in clinical laboratories, and the TOPSIS method was applied to comprehensively evaluate the quality of the total testing process of participating clinical laboratories in each year.Results:From 2016 to 2021, the number of laboratories participating in the external quality assessment plan for quality indicators of clinical laboratory increased from 7 704 to 12 142. Quality indicators in pre-analytical phases: the incorrect sample type rate, incorrect sample container rater, and incorrect fill level rate had been decreasing year by year, reaching 0, 0, and 0.005 8% in 2021, respectively. The anticoagulant samples clotted rate had decreased from 0.068 6% in 2016 to 0.042 8% in 2021, and the blood culture contamination rate from 2017 to 2021 had been 0 without exception. The pre-examination turnaround time had been shortened from 28 minutes in 2016 to 2019 to 24 minutes in 2020 and 2021. Quality indicators in analytical phases: the intra-laboratory turnaround time had been extended from 45 minutes in 2016 to 2019 to 50 minutes in 2020 and 2021. Test covered by an IQC rate had been increasing year by year, reaching 60.61% in 2021. Test with inappropriate IQC performances rate was 0 in 2020 and 2021, the test covered by an EQA-PT control rate was 100%, and unacceptable performances in EQA-PT schemes rate from 2017 to 2021 was 0. The inter-laboratory comparison rate had increased from 1.56% in 2016 to 3.00% in 2021. Quality indicators in post-analytical phases: the incorrect laboratory reports rate, critical values notification rate and timely critical values notification rate had been 0, 100%, and 100%from 2016 to 2021 respectively. The comprehensive evaluation results of TOPSIS method showed that the overall quality level of clinical laboratory testing in 2020 was the highest, with Ci value of 0.850 5, while the lowest Ci value in 2016 was 0.143 6. Conclusions:The quality of clinical laboratory testing in China has been effectively improved. Clinical laboratories should continue to strengthen their monitoring of quality indicators, especially the intra-laboratory turnover time and the inter-laboratory comparison rate, for the purposes of identifying errors, analyzing causes and taking corrective measures to improve quality.
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【Objective】 To conduct the laboratory quality assessment between 12 blood stations in Hebei province, analyze the results and explore the accuracy and comparability of testing, so as to improve the level of testing ability and quality management. 【Methods】 With reference to the external quality assessment rules of National Center for Clinical Laboratories and combined with the instructions of quality assessment samples, daily testing process of the laboratories were assessed. The quality indicators include blood cell count (WBC, RBC, Hb, HCT, MCV, MCH, MCHC and PLT), biochemical items (TP) and coagulation parameters (FIB and FⅧ). 【Results】 There are still problems in laboratories in terms of personnel operation, instrument maintenance and the impact of different reagent batches, especially in biochemical items and coagulation parameters. The pass rate of biochemical items was the lowest, only 72.75%, and that of blood cell count was the highest, reaching 98.75%. 【Conclusion】 With the progress of the project, the quality monitoring level of daily blood sampling tests in the quality control laboratory of each blood station has been improved. However, it is still necessary for each laboratory to improve the testing ability and quality management to a higher level in Hebei.
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Objective To analyze result of the external quality assessment for laboratories of toxicological pathology diagnosis in organizations in China. Methods A total of 86 organizations that participated in the 2020-2021 external quality assessment in laboratory of toxicological pathology diagnosis (hereinafter referred to as "reference units") were selected as research subjects using convenient sampling method, and the assessment results were analyzed. Results The median of total score was 92, and the 0-100 percentiles were 64-100 in these 86 reference units. Among these reference units, 76 were rated as excellent, 10 as qualified, with the excellent and the qualified rate of 88.4% and 11.6%, respectively. No reference unit was rated as unqualified. The rates of excellence of the reference units in public health institutions, pharmaceutical research institutions, drug safety evaluation centers and testing companies were 95.7%, 84.2%, 85.7% and 86.7%, and the qualified rates were 4.3%, 15.8%, 14.3% and 13.3%, respectively. The distribution of excellence and qualification among the four types of reference units showed no statistical difference (P>0.05). The distribution of sample scores according to the three grades of poor, good, and excellent were 4.9%, 20.7%, and 74.5% in public health institutions, 8.6%, 23.7%, and 67.8% in pharmaceutical research institutions, 12.5%, 25.0%, and 62.5% in drug safety evaluation centers, and 5.4%, 17.5%, and 77.1% in testing companies. The proportion of excellence unit in public health institutions was higher than that in pharmaceutical research institutions (P<0.05). Conclusion The overall toxicological pathology diagnostic capabilities in China are good, and various types of reference units demonstrate comparable technical capabilities. However, there is a need for standardization of diagnostic terminology.
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Objective To analyze the quality of blood smear examinations for malaria parasites in Chenzhou City, so as to provide insights into sustainable consolidation of malaria elimination achievements. Methods All positive blood smears from fever patients were irregularly sampled from each county (district) of Chenzhou City from 2018 to 2022 and reexamined, and no less than 3% negative blood smears were reexamined. The preparation, dyeing, cleanliness and microscopic examination results of blood smear were reexamined, and the quality of blood smear reexaminations was assessed using a descriptive statistical method. Results A total of 13 625 fever patients received blood smear examinations for malaria parasites in Chenzhou City from 2018 to 2022, of which 21 were positive and 13 604 were negative; 687 blood samples were reviewed, and the percentage of negative blood smear reexaminations was 4.90% (666/13 604), with a 63.51% rate of qualified negative blood smears preparation, a 67.87% rate of qualified dyeing and a 76.13% rate of qualified cleanliness, and no missing diagnosis found. There were 21 positive blood smears reexamined, and the proportions of qualified blood smears preparation, dyeing and cleanliness were all 85.71%, with 2 smears mistaking Plasmodium species (9.52%). The percentage of qualified negative blood smears preparation was 51.41% in 2022, which reduced by 31.61% in relative to that (75.17%) in 2019 (χ2 = 9.033, P < 0.05), and the percentage of qualified negative blood smears dyeing was 60.19% in 2022, which reduced by 28.82% in relative to that (84.56%) in 2019 (χ2 = 19.498, P < 0.05), while the percentage of qualified negative blood smears cleanliness was 62.96% in 2022, which reduced by 28.93% in relative to that (88.59%) in 2019 (χ2 = 23.826, P < 0.001). In addition, there were no significant differences in the proportion of qualified negative blood smears preparation (χ2 = 0.260, P > 0.05) or dyeing (χ2 = 1.094, P > 0.05) among the three years, while a significant difference was detected in the percentage of qualified negative blood smears cleanliness (χ2 = 12.175, P < 0.05). Conclusions No missing diagnosis was seen in blood smear examinations for malaria parasites among fever patients in Chenzhou City after malaria elimination; however, there were reductions in proportions of qualified blood smears preparation, dyeing and cleanliness. Quality control of blood smear examinations is recommended to be reinforced in key regions of Chenzhou City.
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Photoplethysmography (PPG) is often affected by interference, which could lead to incorrect judgment of physiological information. Therefore, performing a quality assessment before extracting physiological information is crucial. This paper proposed a new PPG signal quality assessment by fusing multi-class features with multi-scale series information to address the problems of traditional machine learning methods with low accuracy and deep learning methods requiring a large number of samples for training. The multi-class features were extracted to reduce the dependence on the number of samples, and the multi-scale series information was extracted by a multi-scale convolutional neural network and bidirectional long short-term memory to improve the accuracy. The proposed method obtained the highest accuracy of 94.21%. It showed the best performance in all sensitivity, specificity, precision, and F1-score metrics, compared with 6 quality assessment methods on 14 700 samples from 7 experiments. This paper provides a new method for quality assessment in small samples of PPG signals and quality information mining, which is expected to be used for accurate extraction and monitoring of clinical and daily PPG physiological information.
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Photopléthysmographie , Apprentissage machine ,Résumé
The quality of moxa is an important factor affecting moxibustion therapy, and traditionally, 3-year moxa is considered optimal, although scientific data are lacking. This study focused on 1-year and 3-year moxa from Artemisia stolonifera and A. argyi(leaf-to-moxa ratio of 10∶1) as research objects. Scanning electron microscopy(SEM), Van Soest method, and simultaneous thermal analysis were used to investigate the differences in the combustion heat quality of 1-year and 3-year moxa and their influencing factors. The results showed that the combustion of A. stolonifera moxa exhibited a balanced heat release pattern. The 3-year moxa released a concentrated heat of 9 998.84 mJ·mg~(-1)(accounting for 54% of the total heat release) in the temperature range of 140-302 ℃, with a heat production efficiency of 122 mW·mg~(-1). It further released 7 512.51 mJ·mg~(-1)(accounting for 41% of the total heat release) in the temperature range of 302-519 ℃. The combustion of A. argyi moxa showed a rapid heat release pattern. The 3-year moxa released a heat of 16 695.28 mJ·mg~(-1)(accounting for 70% of the total heat release) in the temperature range of 140-311 ℃, with an instantaneous power output of 218 mW·mg~(-1). It further released 5 996.95 mJ·mg~(-1)(accounting for 25% of the total heat release) in the temperature range of 311-483 ℃. Combustion parameters such as-R_p,-R_v, D_i, C, and D_b indicated that the combustion heat quality of 3-year moxa was superior to that of 1-year moxa. It exhibited greater combustion heat, heat production efficiency, flammability, mild and sustained burning, and higher instantaneous combustion efficiency. This study utilized scientific data to demonstrate that A. stolonifera could be used as excellent moxa, and the quality of 3-year moxa surpassed that of 1-year moxa. The research results provide a scientific basis for the in-depth development of A. stolonifera moxa and the improvement of moxa quality standards.
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Artemisia , Température élevée , Moxibustion , Feuilles de planteRésumé
The quality of moxa is a key factor affecting the efficacy of moxibustion. Traditional moxa grades are evaluated by the leaf-to-moxa ratio, but there is a lack of support from scientific data. Scanning electron microscopy(SEM), Image Pro Plus, Van Soest method, and stimultaneous thermal analysis(TGA/DSC) were used to characterize the scientific implication of the combustion differences between moxa with different leaf-to-moxa ratios(processed by crusher). The results showed that the median lengths from non-secretory trichomes(NSTs) of natural NSTs and moxa with leaf-to-moxa ratios of 3∶1, 5∶1, 10∶1, and 15∶1 were 542.46, 303.24, 291.18, 220.69, and 170.61 μm, respectively. The cellulose content of moxa increased significantly(P<0.05) with the increase in leaf-to-moxa ratio and the combustion parameters(T_i, t_i, D_i, C,-R_p,-R_v, S, D_b, and J_(total)) all showed an increasing trend. The correlation results showed that the burning properties of moxa(T_i,-R_v, t_i, and J_2) were significantly and positively correlated with cellulose content. NSTs with a length of 1-200 μm were significantly and positively correlated with J_2. NSTs with a length of 200-600 μm were significantly and positively correlated with J_1, T_(peak2), T_(peak1), and-R_v, and negatively correlated with J_(total), T_b, and t_b. As the leaf-to-moxa ratio increases, the NSTs in the moxa become shorter and the cellulose content increases, which is more conducive to ignition performance, heat release, and a milder, longer-lasting burn. The "NSTs-cellulose-TGA/DSC" quantitative evaluation method scientifically reveals the scientific connotation of the combustion of moxa with different leaf-to-moxa ratios and provides a scientific basis for the establishment of quality evaluation methods for moxa with different leaf-to-moxa ratios.
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Trichomes , Moxibustion , Température élevée , Feuilles de planteRésumé
To implement the strategy of test, track and treat to tackle the ongoing COVID-19 pandemic, the number of real-time RT-PCR–based testing laboratories was increased for diagnosis of SARS-CoV-2 in the country. To ensure reliability of the laboratory results, the Indian Council of Medical Research initiated external quality assessment (EQA) by deploying inter-laboratory quality control (ILQC) activity for these laboratories by nominating 34 quality control (QC) laboratories. This report presents the results of this activity for a period of September 2020 till November 2020. A total of 597 laboratories participated in this activity and 86 per cent of these scored ?90 per cent concordance with QC laboratories. This ILQC activity showcased India’s preparedness in quality diagnosis of SARS-CoV-2.
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Objective:To master the provincial-level quality assessment of the self-inspection projects for control and evaluation of drinking water-borne endemic fluorosis in the counties (cities, districts) of Henan Province, so as to ensure the quality of self-inspection.Methods:Totally 30 counties (cities, districts) with drinking water-borne endemic fluorosis in Henan Province were selected as project counties (cities, districts), using consulting and checking data, on-site investigation and review, the implementation of self-inspection projects were audited. The water improvement and the water fluorine content, and the prevalence of dental fluorosis in children aged 8-12 were investigated in villages with drinking water-borne endemic fluorosis, and the provincial-level quality assessment of the self-inspection projects was carried out.Results:A total of 99 villages with drinking water-borne endemic fluorosis in 30 counties (cities, districts) were investigated, and all 30 counties (cities, districts) completed the investigation task of self-inspection projects. A total of 99 water samples were collected, and there were 23 counties (cities, districts) with the same results of county (city, district) self-inspection and provincial-level review of water fluorine, accounting for 76.67%; a total of 5 815 children aged 8-12 were investigated, there were 18 counties (cities, districts) with the same results of county (city, district) self-inspection and provincial-level review of dental fluorosis detection rate, accounting for 60.00%.Conclusions:The self-inspection projects of control and evaluation of drinking water-borne endemic fluorosis at the county (city, district) level in Henan Province are completed well. Most of the self-inspection projects are consistent with the provincial-level review results, but the disease diagnosis ability of grass-roots professional personnel and the detection technical level of laboratory technician in some counties (cities, districts) need to be improved.
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Objective:To evaluate the methodological quality and reporting quality of clinical practice guidelines or consensuses in the field of Chinese pancreatic diseases from 2016 to 2021, and provide reference for formulating clinical practice guidelines and consensuses in this field.Methods:VIP, Wanfang , CNKI and CBM databases were searched for articles published from January 2016 to March 2021. The main index terms were " pancreas" , " guideline" , " consensus" , and the supplementary index terms were " pancreatitis" , " pancreatic cancer" , " pancreatic head cancer" . Two researchers independently selected the literature. The appraisal of guidelines for research and evaluation (AGREE-China) was utilized to assess the methodological quality of the guidelines or consensuses, and the reporting items for practice guidelines in healthcare (RIGHT) tool was used to assess the reporting quality.Results:A total of 14 literature were included, including 7 literature on pancreatic cancer, 3 literature on acute pancreatitis, 1 literature on chronic pancreatitis and 3 literature on others. The results of the assessment by the AGREE-China tool showed that there were no document with a total score greater than or equal to 60.0 points, two with 40.0 to 59.9 points, eleven with 20.0 to 39.9 points, and one with less than 20.0 points. Among the results of RIGHT list, basic information was reported the highest(72.62%) and funding and declaration was the lowest(0).Conclusions:The methodological and reporting quality of the guidelines or consensuses on pancreatic disease in China from 2016 to 2021 are generally not high. In the process of developing domestic guidelines or consensuses on pancreatic diseases, the guideline developer should refer to AGREE-China and RIGHT to improve the quality of clinical practice guidelines or consensuses.
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【Objective】 To conduct a retrospective analysis of HIV Ag-Ab detection by ELISA in our blood center, so as to provide reference for continuous improvement. 【Methods】 The reactive rate of HIV by each reagent, reactive rate of both reagents, re-test rate, concordance rate of initial-repeat test, and reagent utilization rate were counted, and the external quality assessment results were analyzed by PT score and z-ratio. 【Results】 The total reactive rate of HIV was 0.15%. The reactive rate by both reagents was 0.02%. The re-test rates, reactive rates, concordance rates and reagent utilization rates of the two reagents were 0.09% vs 0.08%, 0.07% vs 0.06%, 75.86% vs 78.21%, and 114.54% vs 113.92%, respectively. PT score was 100%, and z-ratio of 7 negative samples and 1 positive sample was less than 2, and of 2 positive samples was more than 3. 【Conclusion】 The laboratory quality monitoring indicators and external quality assessment can effectively monitor the operation of blood testing laboratory.
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【Objective】 To evaluate the laboratory's NAT ability by analyzing the feedback reports of nucleic acid test (NAT) results of external quality assessment (EQA) of National Center for Clinic Laboratories (NCCL), so as to improve the laboratory management details and ensure blood safety. 【Methods】 The data of NCCL NAT EQA of blood screening laboratory of Tianjin Blood Center (a total of five occasions from Jan 2019 to Jun 2021) were statistically analyzed. 【Results】 From Jan 2019 to Jun 2021, the laboratory participated in EQA for five times and all the results were qualified. The test results of NAT EQA HIV RNA/HCV RNA/HBV DNA detected by R1, R2 and R4 were consistent with the reference results. R3 showed false positive results (CT value 40.46) in the single donation detection of sample No.1925 in HCV RNA. Unreported data of the laboratory was that in the first EQA in 2021, the R4 showed false positive results (CT value 35.8) in in the single donation detection of sample No.2113 in HIV RNA. 【Conclusion】 The performance of each NAT screening system in our laboratory is relatively stable except occasional false positive results influenced by every factor. Potential problems can be found and continuously improved by assaying EQA reports and the extended experimental results of EQA samples to further improve the detection ability.
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【Objective】 To analyze the difference of circulating threshold (Ct) of polymerase chain reaction (PCR) in blood station laboratories during the external quality assessment, and to put forward suggestions for the quality improvement of participating laboratories. 【Methods】 From 2018 to 2021, the blood station laboratories participated in the external laboratory quality assessment of CITIC including blood screening items with nucleic acid testing method. The data of Roche diagnostic reagent group were used as the source, and the detected Ct values of three groups of quality control samples of HBV A subtype (400 IU/mL), HCV 1b subtype (400 IU/mL) and HIV B genotype (500 IU/mL) were used as the objects. The data were grouped according to quality control (sample) batches, reagent batches and different laboratories. Using the statistical method of variance analysis (assuming P<0.05 as significant), the detected Ct value of each group was analyzed. 【Results】 For the three items (HBV/HCV/HIV), the grouping data involving 42 batches of quality control (13/12/17), 28 batches of reagent (11/8/9) and 57 laboratories (19/19/19) were selected. The grouping analysis of quality assessment batches shows that there was no significant difference between HBV and HCV quality assessment batches, and there was no significant difference between other HIV batches except the two batches of HIV quality assessment samples released in 2021. The grouping analysis of each reagent batch showed that there was no significant difference between each reagent batch for HCV and HIV detection, while there was significant difference between two batches of HBV reagents. After excluding the data groups with significant differences in the quality control batch groups and the reagent batch groups, the detected Ct value of each laboratory group had extremely significant differences in the three items of HBV, HCV and HIV. Through pairing analysis, it was found that four laboratories had significant differences with most other laboratories in the three items, mainly manifested in the high mean value of Ct. 【Conclusion】 For the blood station laboratories with correct test results of quality assessment samples, there are differences in Ct values detected by PCR, which may be mainly caused by the detection ability of the participating laboratories.
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@#Plasmodium knowlesi is the most common zoonotic parasite associated with human malaria infection in Malaysia. Apical membrane antigen 1 (AMA1) protein in the parasite plays a critical role in parasite invasion into host cells. To date, there is no complete three-dimensional ectodomain structure of P. knowlesi AMA1 (PkAMA1) protein. The knowledge of a protein structure is important to understand the protein molecular functions. Three in silico servers with respective structure prediction methods were used in this study, i.e., SWISS-MODEL for homology modeling and Phyre2 for protein threading, which are template-based modeling, while I-TASSER for template-free ab initio modeling. Two query sequences were used in the study, i.e., native ectodomain of PkAMA1 strain H protein designated as PkAMA1-H and a modified PkAMA1 (mPkAMA1) protein sequence in adaptation for Pichia pastoris expression. The quality of each model was assessed by ProSA-web, QMEAN and SAVES v6.0 (ERRAT, Verify3D and Ramachandran plot) servers. Generated models were then superimposed with two models of Plasmodium AMA1 deposited in Protein Data Bank (PDB), i.e., PkAMA1 (4UV6.B) and Plasmodium vivax AMA1 (PvAMA1, 1W81) protein structures for similarity assessment, quantified by root-meansquare deviation (RMSD) value. SWISS-MODEL, Phyre2 and I-TASSER server generated two, one and five models, respectively. All models are of good quality according to ProSA-web assessment. Based on the average values of model quality assessment and superimposition, the models that recorded highest values for most parameters were selected as best predicted models, i.e., model 2 for both PkAMA1-H and mPkAMA1 from SWISS-MODEL as well as model 1 of PkAMA1-H and model 3 of mPkAMA1 from I-TASSER. Template-based method is useful if known template is available, but template-free method is more suitable if there is no known available template. Generated models can be used as guidance in further protein study that requires protein structural data, i.e., protein-protein interaction study.
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Objective:To construct a prokaryotic expression vector for human retinol binding protein 4 (hRBP4) that allows technicians to obtain hRBP4 purified protein with low cost, high efficiency, high concentration and high purity.Methods:The hRBP4 coding sequence provided by National Center for Biotechnology Information was optimized by E. coli codons, and a synthetic DNA fragment was cloned into the PET-28A (+) prokaryotic expression vector to construct a recombinant hRBP4 expression plasmid. The recombinant protein was transformed into E. coli BL21, and the induced expression conditions (temperature, rotate speed and isopropyl β-d-thiogalactoside concentration) were optimized. The recombinant protein was purified by His fusion tag. Results:The recombinant hRBP4 prokaryotic expression plasmid was successfully constructed, and the expression concentration and induction temperature of the recombinant protein were optimized. The results of sodium dodecyl sulfate polyacrylamide gel electrophoresis showed that a band with a relative molecular weight of 26 000 daltons was clearly visible in the purified product. The purified hRBP4 protein could be detected clinically, and there was a good linear relationship between the dilution ratio and the detection concentration.Conclusions:The recombinant hRBP4 protein has high purity, high concentration, and short production cycle. It has the potential to become a candidate for reference materials for laboratory quality evaluations.
Résumé
Objective:To explored how medical and health institutions can improve the quality of Investigator-Initiated Trials(IIT).Methods:Strategies and measures were proposed to ensure the quality of IIT based on the combination of related literature review and IIT management experiences analysis.Results:Institutions can carry out following measurements to improve the quality of IIT, which include setting up tailored IIT management department, establish centralized management system; conducting systematic regulatory and clinical research methodology trainings; develop effective quality control system and quality assessment index, applying electronic information system and platform to optimize the management.Conclusions:Strengthen the standardized management is an effective strategy to improve the quality of IIT in medical and health institutions.