Quality evaluation of inactivated poliomyelitis vaccine made from Sabin strains after optimization / 中国生物制品学杂志

@#Objective To evaluate the product quality of inactivated poliomyelitis vaccine made from Sabin strains(sIPV)after optimization of preparation formula.Methods The quality attributes of sIPV products after preparation optimization(no phenol red and no bacteriostatic agent)were evaluated,and the quality comparability with the listed sIPV products was analyzed;270 Wister rats of half male and half female were immunized with the finished products before and after preparation optimization simultaneously by intramuscular injection,measured for the level of neutralizing antibody in serum,evaluated for the immunogenicity,and analyzed for the compa-rability;The finished products with optimized preparation were placed at 37 ℃,room temperature(20～25 ℃)and 2～8 ℃ for accelerated and long-term stability tests separately,detected for the content of key indicator D antigen to evaluate the stability,and analyzed for the comparability with historical data of the listed products.Results After preparation formula optimization,the detection results of the sIPV vaccine for typeⅠ,Ⅱ,and Ⅲ D antigen content,protein content,pH value,Vero cell protein residue,bovine serum albumin residue,Vero cell DNA residue,and free formaldehyde content all conformed to the requirements of Chinese Pharmacopoeia Ⅲ (2020 edition)and the enterprise standard. Before and after the process optimization,the quality attributes,immunogenicity and accelerated and long-term stability trends were consi-stent.Conclusion The formulation of the optimized sIPV vaccine no longer contains phenol red and bacteriostatic agent ingredients,of which the safety has been improved;The quality attributes,immunogenicity,and stability of the product are highly similar to those before optimization;All indicators met the requirements during the validity period and the product has good stability.

Exploration of the comparison between different biochemical detection systems based on sigma metrics / 中华检验医学杂志

Objective:To explore the feasibility of using the sigma metrics calculated with the data of internal quality control for the comparison of the analytical performance between different biochemical analyzers.Methods:The internal quality control results of twenty-five biochemical assays in the biochemical analyzers of the department of clinical laboratory in Cancer Hospital from February 1, 2021 to July 31, 2021 were collected. The formula sigma =( TEa- Bias)/ CV was used to calculate the sigma metrics of two different levels of the biochemical assays including albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, calcium, cholesterol, creatine kinase, chlorine, creatinine, γ- glutamyltranspeptidase, blood glucose, high density lipoprotein cholesterol, immunoglobulin A, immunoglobulin G, immunoglobulin M, potassium, lactate dehydrogenase, low density lipoprotein cholesterol, sodium, inorganic phosphorus, total bilirubin, triglyceride, total protein, urea, uric acid. The imprecision was obtained by the coefficient of variation of internal quality control. The bias was calculated by the deviation between the mean of internal quality control of the comparison instrument and the target instrument. The allowable total error ( TEa) was based on People's Republic of China Health Industry Standard (WS/T403-2012) or EQA standard of National Center for Clinical Laboratories (NCCL). Compared the sigma values of the comparison instrument relative to the target instrument with the average percentage bias obtained by the traditional comparison method. Quality goal index was used to analyze the causes of poor performance and judge the results of comparison. Results:Compared with the target instrument Beckman AU5800-3, the comparison instrument Beckman AU5800-1 had 10 assays with σ>6, accounting for 40%, 23 assays with σ>3, accounting for 92%, and only albumin and blood glucose showed σ<3. Through statostical analysis, the comparisons of all assays were passed. The comparison instrument Beckman AU5800-2 had 8 assays with σ>6, accounting for 32%, 20 assays with σ>3, accounting for 80%. Only alkaline phosphatase, calcium, lactate dehydrogenase, total protein and urea showed σ<3. Through statostical analysis, the comparisons of GGT and IgM failed. For the traditional comparison method, the percentage bias between the comparison instruments and the target instrument were all within the range of the evaluation standard. But there was no significant correlation between the σ value and the average bias of the traditional comparison method, and the biases were correlated.Conclusions:Using the sigma metrics calculated with the data of internal quality control for the comparison of different detection systems is a convenient and operable method. It can monitor the comparability between different detection systems in the laboratory at any time and be the supplement of the traditional comparison method.

Application of improved comparability verification method in performance verification of instruments and equipment / 中国输血杂志

【Objective】 To explore the viability of improved comparability verification method for the performance verification of automatic biochemical analyzer in blood centers. 【Methods】 According to the relevant requirements of User Verification of Performance for Precision and Trueness; Approved Guideline-Second Edition (EP15-A2) and Guideline for Comparability Verification of Quantitative Results with One Health Care System(WS/T 407-2012), the performance of the newly purchased Beckman Coulter AU480 automatic biochemical analyzer was confirmed by means of comparability verification, and compared with the current Olympus AU400 automatic biochemical analyzer. 【Results】 The detection results given by Beckman AU480 biochemical analyzer on 5 samples for ALT detection performance test were significantly correlated with the target value (R2=0.998), and the trueness verification results met the requirements.The CV of medium and high ALT levels was 2.36% and 1.20%, respectively, within the acceptable standard range(<5%), and the precision verification results meet the requirement.The comparison deviation of two devices for medium and high ALT levels was 0.47% and 1.62%, respectively, within the acceptable standard range (<5%). The detection results of ALT from 40 blood donors given by two devices were significantly correlated (R2=0.956), and the precision verification results met the requirements.In the validation of linear evaluation, there was a good linear relationship between the expected and measured results (r=0.997)among samples with 6 levels of concentrations. 【Conclusion】 The comparability verification method is suitable for the performance verification of automatic biochemical analyzer in blood centers.

Equivalence of entrustable professional activities and context-dependent item sets as summative assessments in undergraduate physical therapy programs

Background@#Summative assessment of student performance should provide information on achievement of program outcomes to support evaluation decisions. Alternative approaches to the traditional assessment systems like the written licensure examinations in Physical Therapy (PT) should be explored to ensure valid measurement of achievement of these terminal outcomes. @*Objective@#The study aimed at establishing equivalence of two summative assessments new to PT in measuring achievement of the PT outcomes: work-based assessment using Entrustable Professional Activities (EPA) and knowledge-based assessment using Context-Dependent Item Sets (CDIS). @*Methodology@#Thirty-two newly graduated PT's underwent a one-week EPA assessment and took a 102-item CDIS test (based on 14 clinical vignettes). Qualitative data from blueprint review, group face-to-face interviews with participants and assessors, and field notes from observations, and quantitative data from EPA entrustment decisions and CDIS scores were utilized to ascertain their comparability in terms of Purpose, Administration, Quality and Decisions. This was used to determine the extent of equivalence of the two assessments. @*Results@#Review of both blueprints show alignment with PT outcomes, with integrative content motivating participants towards professional development. Administration were equally acceptable to users, though EPA had more practice opportunities with a longer assessment time. Entrustment decisions in EPA had a high inter-rater reliability, while CDIS had low reliability, with most items having poor discriminative power. Decisions of “pass” or “fail” had good concordance when high prevalence indices were considered. @*Conclusion@#There is high extent of equivalence in purpose of EPA and CDIS but are not equivalent in terms of administration. There is moderate equivalence in quality and decisions, with potential for increased concordance if improved quality of CDIS is attained.

Study on differentiation and features of the medical records about constipation in ancient books with doctors Wumen medical school / 国际中医中药杂志

Objective@#The characteristics of prescription medication for constipation in Wumen doctors in Ming and Qing Dynasties were analyzed by data mining method, so as to provide reference for the treatment of contemporary clinical constipation.@*Methods@#The Wumen medical school doctors in Ming and Qing Dynasties treating constipation in clinical case were selected for digital acquisition and process. The association rules and complex networks analysis were used for data mining in order to explore experience of famous doctors in Wumen medical treated constipation.@*Results@#A total of 202 cases records of constipation were collected from acient TCM books by the database of ancient books and literatures of library of Nanjing University of Traditional Chinese Medicine. The results showed that the highest syndromes of 202 prescriptions was Qi stagnation and yin deficiency, followed by damp-heat, blood deficiency and liver-stomach disharmony, and the top ten medicines for internal use were angelica, almond, arborvitae, flaxseed, pinellia, cistanche, dried rehamnnia root, radix paeoniae alba, rhubarb, poria, licorice, etc. The core medicine in pairs included the Platycodon grandiflorum-almonds, safflower-peach kernel, safflower-angelica and other drugs outside, carthami-semen pruni-Peach kernel, carthami-semen pruni-Angelica, carthami-angelica-peach, peony-rhubarb-magnolia.@*Conclusions@#Most of the doctors in the Ming and Qing Dynasties believed that constipation was based on deficiency and reality, took Xinrun Tongluo as its treatment method, and paid attention to the treatment of activating blood circulation, warming yang and regulating qi and resolving phlegm, and emphasized the relationship between constipation and lung, spleen, liver and kidney.

Study on differentiation and features of the medical records about constipation in ancient books with doctors Wumen medical school / 国际中医中药杂志

Objective The characteristics of prescription medication for constipation in Wumen doctors in Ming and Qing Dynasties were analyzed by data mining method, so as to provide reference for the treatment of contemporary clinical constipation. Methods The Wumen medical school doctors in Ming and Qing Dynasties treating constipation in clinical case were selected for digital acquisition and process. The association rules and complex networks analysis were used for data mining in order to explore experience of famous doctors in Wumen medical treated constipation. Results A total of 202 cases records of constipation were collected from acient TCM books by the database of ancient books and literatures of library of Nanjing University of Traditional Chinese Medicine. The results showed that the highest syndromes of 202 prescriptions was Qi stagnation and yin deficiency, followed by damp-heat, blood deficiency and liver-stomach disharmony, and the top ten medicines for internal use were angelica, almond, arborvitae, flaxseed, pinellia, cistanche, dried rehamnnia root, radix paeoniae alba, rhubarb, poria, licorice, etc. The core medicine in pairs included the Platycodon grandiflorum-almonds, safflower-peach kernel, safflower-angelica and other drugs outside, carthami-semen pruni-Peach kernel, carthami-semen pruni-Angelica, carthami-angelica-peach, peony-rhubarb-magnolia. Conclusions Most of the doctors in the Ming and Qing Dynasties believed that constipation was based on deficiency and reality, took Xinrun Tongluo as its treatment method, and paid attention to the treatment of activating blood circulation, warming yang and regulating qi and resolving phlegm, and emphasized the relationship between constipation and lung, spleen, liver and kidney.

Analysis on the external quality assessment results and comparability of detection systems and methods for tumor markers in Shandong province during 2015 and 2017 / 临床检验杂志

Objective@#To analyze the comparability of different detection systems and methods for tumor markers (TM) by reviewing the results of TM external quality assessment (EQA) in Shandong province during 2015 and 2017. @*Methods@#The results of TM EQA from the Shandong Provincial Clinical Laboratory Center during 2015 and 2017 were collected, and grouped by the detection system or method. After outliers were removed by the CLInet EQA software, the mean and coefficient of variation (CV) in each group were calculated with median as the target value. The difference of TM results in different detection systems were compared by the Kruskal-Wallis H test. @*Results@#Taking alpha-fetoprotein (AFP) as an example, the average CV of different detection methods of TM EQA during 2015 and 2017 ranged from small to large in order of microparticle enzyme immunoassay, electrochemiluminescence, acridine ester chemiluminescence and chemiluminescence. The trends of CV of the other tumor markers were similar to AFP. The average CV of individual marker in electrochemiluminescence group was lower than that in microparticle enzyme immunoassay group. The intra-group CVs of imported detection systems such as Roche, Beckman etc. were relatively ideal, and the average CVs of most tumor markers were less than 10%. However, the intra-group CVs of domestic detection systems such as Shenzhen Snibe, Zhengzhou Autobio etc. were not ideal, and the average CVs of most tumor markers were more than 10%. The target values of different detection systems varied with different items and batches, and there were great variation in carbohydrate antigen (CA) series. @*Conclusion@#The results of TM detected by the same automatic detection system are comparable. However, the results of TM detected by most different detection systems and methods are not comparable.

Data Mining Research on Academic Thought of Treating Chest Pain from Famous Medicalists since the Han Dynasty / 世界科学技术-中医药现代化

The analysis on regularity of comparability among famous physician's prescriptions for treating chest pain since the Han Dynasty will be helpful to treat chest pain and develop new herbs.The Chinese Medicine Auxiliary System (V2.5) was used to analysis the regularity of comparability by inputting the most famous 101 prescriptions for the treatment of chest pain from the Han Dynasty to Qing Dynasty.The results showed that the most common single drugs were cassia twig,40 times (39.6％).The most common couplet medicines were licorice and poria cocos,21 times (20.8％).The most common triangle medicines were ginger,pinellia,and cassia twig,13 times (12.9％).The most common drug combination based on association rules was the combination of cassia twig,peucedani radix→ginger (confidence level of 0.909 1).The core drugs based on complex network was cassia twig,licorice,and etc.New prescription combinations based on the entropy method were 11 new prescriptions including allium,cassia twig,poria,and almonds.It was concluded that there were regularity of comparability in ancient prescriptions for treating chest pain.Approaching and developing medicine for the treatment of chest pain should be from the following 6 points.The priority choice of single drug was cassia twig,and etc.The priority choice of couplet medicines was licorice and poria cocos,etc.The priority choice of triangle medicines was ginger,pinellia,cassia twig,and etc.The combination of high correlation should be chosen in treating chest pain,such as cassia twig,peucedani radix→ginger,and etc.The core drugs are necessary.In the warming yang method,cassia twig is the core drug and ginger is the auxiliary drug,and etc.New prescription combination,such as allium,cassia twig,poria,almonds,and etc.should be applied.

Reproducibility of VERION Digital Guidance System and its comparability with iTrace, Lenstar LS900 and manual keratometer in measuring keratometry and astigmatism / 眼科新进展

Objective To analyze the reproducibility of keratometry and astigmatism measured by the VERION Digital Guidance System and the comparability of VERION with iTrace,Lenstar LS900 and manual keratometer.Methods The keratometry of 62 cataract patients were measured using four different devices.The steep keratometry (Ks),flat keratometry (Kf),astigmatic magnitude,astigmatic axis,cylinder at 0-degree meridian (vector component,J0) and cylinder at 45-degree meridian (vector component,J45) from each machine were recorded and analyzed.The three repeated measurements and the results of VERION system with other three devices were compared to analyze the reproducibility and comparability of VERION system.Results Reproducibility:Intraclass correlation coefficients and Cronbach's alpha values were higher than 0.9 for Ks,Kf,astigmatic magnitude,astigmatic axis,J0 and J45 measured by the VERION system (all P ＜ 0.001).Comparability:The results of Ks and magnitude of astigmatism of VERION were larger than the iTrace (all P ＜ 0.05) in the paired-samples t test.There was no statistical difference for the rest of parameters (all P ＞ 0.05).The Bland-Altman graphs revealed the 95％ limits of agreement (LOA) of J0,J45 and the astigmatic axis between VERION and iTrace were (-0.31-0.35) D,(-0.25-0.31) D and-13.5 °-12.3 °,respectively;There was no statistical differences for all parameters except for J45 in the paired-samples t test between the VERION and Lenstar LS900 (all P ＞ 0.05).The Bland-Altman graphs revealed the 95％ LOA of J0,J45 and the astigmatic axis were (-0.25-0.31)D,(-0.27-0.36) D and-13.5°-11.0°,respectively;There were statistical differences for the results of Kf and magnitude of astigmatism between the VERION and manual keratometer (all P ＜ 0.05).The Bland-Altman graphs revealed the 95％ LOA of J0,J45 and the astigmatic axis between VERION and manual keratometer were (-0.38-0.35) D,(-0.41-0.42) D,-12.6°-16.4°,respectively.Conclusion The VERION system is a reliable system for the measurement of keratometry and astigmatism.The keratometry and astigmatic magnitude of the VERION system have a good agreement with the iTrace,Lenstar LS900 and manual keratometer.However,the astigmatic axis measurements are significantly different among the four devices.

Characterization and comparability of biosimilars: a filgrastim case of study and regulatory perspectives for Latin America

Background: Developing countries have an estimate of ten times more approved biosimilars than developed countries. This disparity demands the need of an objective regulation that incorporates health policies according to the technological and economical capabilities of each country. One of the challenges lies on the establishment of comparability principles based on a physicochemical and biological characterization that should determine the extent of additional non-clinical and clinical studies. This is particularly relevant for licensed biosimilars in developing countries, which have an extensive clinical experience since their approval as generics' in some cases more than a decade. To exemplify the current status of biosimilars in Mexico' a characterization exercise was conducted on licensed filgrastim biosimilars using pharmacopeial and extended characterization methodologies. Results: Most of the evaluated products complied with the pharmacopeial criteria and showed comparability in their Critical Quality Attributes (CQAs) towards the reference product. These results were expected in accordance with their equivalent performance during their licensing as generics. Accordingly' a rational approval and registration renewal scheme for biosimilars is proposed, that considers the proper identification of CQAs and its thoroughly evaluation using selected techniques. Conclusions: This approach provides support to diminish uncertainty of exhibiting different pharmacological profiles and narrows or even avoids the necessity of comparative clinical studies. Ultimately, this proposal is intended to improve the accessibility to high quality biosimilars in Latin America and other developing countries.

Evaluation for the performance of Sysmex XN 20 A1 automation blood cell analyzer / 中国医学装备

Objective:To evaluate the performance for the Sysmex XN20 A1 automation blood cell analyzer.Methods: The precision, contaminative rate, linear range, blank, accuracy and various sample models were verified, and low values of blood platelet were compared with the methods of microscopy and dye.Results:The contaminative rate was lower than 0.4%. The linear arrange and precision were well for the analyzer. The values of RBC, HGB and PLT were within the range of 1±0.05 and the correlation coefficients were higher than 0.975. The bias of average and constant values by the accuracy verification samples test met the demands of accuracy. And the relative differences of various sample models meet the requirements of the comparability. The variable coefficient of low values of PLT was lower than 4% by the dye method.Conclusion: The Sysmex XN20 A1 automation blood cell analyzer has the characteristics of perfect precision, accuracy, low contaminative rate, broad linear arrange and good repeatability for the low level PLT. It can be applied in clinical laboratory.

Verification of the Comparability of Laboratory Results from Two Instruments within One Health Care System According to Clinical and Laboratory Standard Institute EP31-A-IR

BACKGROUND: For convenience, multiple instruments can be used to measure the same laboratory results within one health care system. However, the laboratory must verify the comparability of the results. In this study, we evaluated a method for verifying the comparability of patient results obtained from two instruments within one health care system, EP31-A-IR, proposed by the Clinical and Laboratory Standards Institute. METHODS: Using the range test proposed by the EP31-A-IR, we evaluated the comparability of 17 clinical chemistry test results from the HITACHII/MODULAR system (Roche Diagnostics, Switzerland) and the TOSHIBA/200FR system (Toshiba Medical Systems Co., Japan). The 0.33× biological variability, allowable total error, and standards of the Clinical Laboratory Improvement Amendments were used to determine the acceptance criteria. RESULTS: Among 16 test parameters, the differences of means between the two instruments were less than their range rejection limit in 15 tests, and so the comparability between the two instruments was considered acceptable. Creatinine was not evaluated using this protocol because its range rejection limit was not deducible from the EP31-A-IR statistics table. CONCLUSIONS: The EP31-A-IR guideline is useful for verifying the comparability of results between two instruments. However, not all parameters are covered by the guideline. With consideration of the characteristics of each test parameter, each laboratory should devise its own method for evaluating comparability.

Statistical issues in randomised controlled trials: A narrative synthesis

ABSTRACT: Randomised controlled trials (RCT s) are gold standard in the evaluation of treatment efficacy in medical investigations, only if well designed and implemented. Till date, distorted views and misapplications of statistical procedures involved in RCTs are still in practice. Hence, clarification of concepts and acceptable practices related to certain statistical issues involved in the design, conduct and reporting of randomised controlled trials is needed. This narrative synthesis aimed at providing succinct but clear information on the concepts and practices of selected statistical issues in RCT s to inform correct applications. The use of tests of significance is no longer acceptable as means to compare baseline similarity between treatment groups and in determining which covariate(s) should be included in the model for adjustment. Distribution of baseline attributes simply presented in tabular form is however, rather preferred. Regarding covariate selection, such approach that makes use of information on the degree of correlation between the covariate(s) and the outcome variable is more in tandem with statistical principle(s) than that based on tests of significance. Stratification and minimisation are not alternatives to covariate adjusted analysis; in fact they establish the need for one. Intention-to-treat is the preferred approach for the evaluation of primary outcome measures and researchers have responsibility to report whether or not the procedure was followed. A major use of results from subgroup analysis is to generate hypothesis for future clinical trials. Since RCT s are gold standard in the comparison of medical interventions, researchers cannot afford the practices of distorted allocation or statistical procedures in this all important experimental design method.

Comparability verification of detection results of different blood cell analysis systems in same hospital / 国际检验医学杂志

Objective To evaluate the comparability of the detection results of different blood cells analysis systems in same hos-pital.Methods Referring to the Guideline for Comparability Verification of Quantitative Test Results in Medical Institutions,the comparability validation protocol was established.The EDTA-K2 anticoagulation fresh whole blood samples with proper concentra-tion were detected for 5 parameters of HGB,RBC,HCT,PLT and WBC by 4 systems (Sysmex XT-1800i,Sysmex XT-2000,Sys-mex XT-4000i and Mindray BC-5800).The range was calculated and the detection results consistency analysis was performed.Re-sults The acceptable standard of critical differentials was intended to be HGB3.5%,RBC3%,HCT3%,PLT12.5% and WBC 7.5%.The replication detection was at least 2 times and up to 5 times.The ranges of 3 concentrations after replication detection and sample comparison were 2.87%-6.29%,1.57%-2.99%,1.95%-4.77%,12.81%-25.74% and 6.72%-11.13% respective-ly.The ranges of RBC detection results in 4 systems were smaller than the critical differentials,the validation was passed.The ran-ges of HGB,HCT,PLT and WBC detection results in 4 systems all had the condition of more than the critical differentials,the vali-dation did not passed.After removing the test system with obvious bias,the validation of the detection results by other test systems was passed.Conclusion The RBC detection results by 4 systems have the comparability;the HGB,HCT and PLT detection results by Sysmex XT-1800i,Sysmex XT-2000i and Sysmex XT-4000i have the comparability;the WBC detection results by Sysmex XT-1800i,Sysmex XT-2000i and Mindray BC-5800 have the comparability.

Evaluation of critical quality attributes of an anti-HER2 humanized monoclonal antibody drug / 中国药学杂志

OBJECTIVE: To perform a multidimensional study on the critical quality attributes of a therapeutic anti-HER2 humanized monoclonal antibody targeting HER2-positive breast cancer. METHODS: The critical quality attributes such as purity, impurities, structure, and function were evaluated using multidimensional analytical techniques including HPLC, CE-SDS, dynamic light scattering, circular dichroism, differential scanning calorimeter, LC-MS/MS, in vitro bioactivity assay and SPR binding kinetics. RESULTS: The monomer content of the antibody was more than 98% while the polymer impurities were less than 2%. The sum of heavy chain and light chain peak area was over 97% while the non-glycosylated heavy chain impurities area was less than 1% on the CE-SDS electrophoretogram. The antibody drug demonstrated comparable CD spectrum, predicted secondary structure and unfolding temperatures to the reference product. It had highly similar N-glycan profile involving glycosylation site and N-glycan types to the reference product. The analysis showed no significant difference in the functional CQAs like BT474 proliferation inhibiting bioactivity, ADCC efficacy, the binding affinity to HER2 and Fc receptors between the evaluated drug product and the reference. CONCLUSION: The characteristics of the monoclonal antibody drug such as high purity and few impurities indicate homogeneity and low-risk of safety issues. High similarity to the reference has been verified in multiple aspects like higher structure, glycosylation and function. The positive quality evaluation result is a prerequisite for clinical research. Moreover, to some extent, there can be potential correlation between CQAs and clinical safety and efficacy.

Preparation and Evaluation of the Reference Materials for Plasma von Willebrand Factor Antigen Testing / 现代检验医学杂志

Objective To prepare and evaluate the reference materials for plasma von Willebrand Factor antigen testing with fresh frozen plasma.Methods The candidates were prepared by low temperature centrifugation in 5 different concentration levels.The homogeneity and stability of the preparation was evaluated according to the ISO Guide35 and CNAS-GL03.The comparability between STAGO and IL system was evaluated according to the WS/T 356-2011.Then the preparations were characterized by six laboratories with the Secondary Coagulation Standard established by NIBSC(SSCLOT4).Results Homogeneity evaluation of the preparation showed that there was no statistically significant difference between the groups (P >0.05),the F values of factor analysis of variance were 0.317~0.844,the uncertainty range was 1.01% ~2.06%.A linear regression based on stability evaluation indicated that the linear trend (within 24 weeks)was insignificant (P >0.05). The uncertainty range of long-term (within 24 weeks)stability was 0.79% ~ 1.20%.The results of the preparations on STAGO and IL system were comparable.The certificated values of the candidates were range from 12.2% to 138.9% with uncertainties were 0.06%~0.09%,respectively.The range of combined standard uncertainty was 0.03% ~ 0.16% while the expanded uncertainty was 2.2%~6.7%.Conclusion The reference materials for von Willebrand Factor antigen testing were stable and homogenous with comparability between STAGO and IL.The method of characterization was accurate and reliable.

The research on the comparability of thyroid hormone test results using two different detection systems / 国际检验医学杂志

Objective To analysis of the thyroid hormone test results of Abbott Architect ci16200 automatic biochemical-im-mune analyzer (Abbott system) and Roche Cobas e601 automated immunoassay analyzer (Roche system) .Methods The thyroid hormone(including T4 ,FT4 ,T3 ,FT3 ,TSH ) levels of 93 cases of serum samples were respectively detected by Abbott system (CMIA) and Roche system (ECLIA) ,and the results were analyzed .Results The thyroid hormone test results of the two systems had a good correlation ,and the coefficients of T4 ,FT4 ,T3 ,FT3 ,and TSH were 0 .960 ,0 .962 ,0 .976 ,0 .900 ,and 0 .999(P<0 .01) . However ,there were significant difference of the detection results of the two systems(P<0 .05) .Conclusion The thyroid hormone test results of Abbott system and Roche system are not comparable .

Nota sobre el concepto de inconmensurabilidad los escritos de J. Bruner sobre cultura y mente y de Castorina sobre las representaciones sociales / A note on the concept of incommensurability the writings of J. Bruner on culture and mind, and of Castorina on social representations / Nota sobre o conceito de incomensurabilidade dos escritos de J. Bruner sobre cultura e mente e de Castorina sobre as representações sociais

En el presente artículo se analiza el concepto de inconmensurabilidad a la luz de lo que está ocurriendo en diferentes disciplinas relacionadas con la psicología. Se detecta que hay muchos conceptos que se aplican en diferentes estudios sin que exista una elaboración o re-elaboración conceptual a partir de nuevos atributos identificados en un determinado fenómeno; a veces es una mera sumatoria terminológica, y en otros casos se trasladan conceptos sin precisar la ontología o la taxonomía de la que forman parte. Se describen dos trabajos teóricos - el de Castorina y el de Bruner - para ejemplificar los argumentos que se exponen. Finalmente, se argumenta que existiría un cierto margen de espacio común entre las teorías psicológicas, el cual, se podría representar, por ejemplo, en la resolución de "problemas" (tanto teóricos como empíricos. Es decir, una teoría es válida mientras sea apelada por una parte importante de la comunidad científica (para investigación principalmente, y secundariamente para la práctica profesional).

In the present paper, the concept of incommensurability is analyzed in the light of what is happening in different disciplines related to psychology. It is detected that there are many concepts that are applied in different studies without a conceptual elaboration or re-elaboration from new attributes identified in a certain phenomenon. Sometimes it consists of merely adding together many terms; in other cases, concepts are transferred without specifying the ontology or taxonomy of which they are part. Two theoretical works are described - one by Castorina and the other one by Bruner - to exemplify the arguments expressed. Finally, it is argued that a certain margin of common space would exist between psychological theories, which could be represented, for example, in the resolution of "problems" (both theoretical and empirical). That is to say, a theory is valid while it is questionned by an important sector of the scientific community (mainly for research and secondarily for professional practice).

No presente artigo analisa-se o conceito de incomensurabilidade à luz do que está ocorrendo em diferentes disciplinas relacionadas com a psicologia. Detecta-se que há muitos conceitos que se aplicam em diferentes estudos sem que exista uma elaboração ou reelaboração conceitual a partir de novos atributos identificados em um determinado fenômeno; às vezes é uma mera somatória terminológica, e em outros casos se trasladam conceitos sem especificar a ontologia ou a taxonomia da que formam parte. Descrevem-se dois trabalhos teóricos - o de Castorina e o de Bruner - para exemplificar os argumentos que são expostos. Finalmente, argumenta-se que existiria certa margem de espaço comum entre as teorias psicológicas, que poderia ser representado, por exemplo, na solução de "problemas" (tanto teóricos como empíricos). Ou seja, uma teoría é válida enquanto for apelada por uma parte importante da comunidade científica (para pesquisa principalmente, e secundariamente para a prática profissional).

Analysis of Comparability Test between Reagent Lots in Immunoassay

Lot-to-lot reproducibility is an important issue in immunoassays and reagent lot-to-lot comparability test comparing the results of new reagent lot with those of used lot using patients' samples or controls is usually performed to detect the difference between lots. However, there are no universally used acceptability criteria regarding reagent lot-to-lot comparability test. We performed reagent comparability test between different lots of alpha-fetoprotein (AFP) reagents and tried to determine its comparability by several criteria. Both the commercialized controls and in-house controls for AFP made from pooled patients' sera were measured 10 times using the old and new lots of reagents, whenever a reagent lot was changed. The differences in the mean control values, the percent difference (% difference), and the difference to between-run standard deviation ratio (D:SD ratio) between successive lots were calculated. We compared the results of reagent comparability test to arbitrarily determined acceptability criteria suggested by CLSI C54-A. Although comparability between reagent lots was determined according to how strictly we set the criteria, some lot-to-lot differences between certain pairs of lots exceeded the criteria. We hope that the results of this study might be helpful to perform reagent lot-to-lot comparability test and set the criteria for reagent comparability test between lots in other laboratories.

Comparison of the Performance in Two Different Korean Versions of Mini-Mental State Examination: MMSE-KC and K-MMSE / 신경정신의학

OBJECTIVES: We compared the scores of the MMSE-KC (Korean version of MMSE in the Korean version of CERAD Assessment Packet) and K-MMSE (Korean MMSE), and analyzed the influences of age, gender, and educational level on the differences between the two. METHODS: We administered the MMSE-KC and K-MMSE simultaneously along with geriatric depression scale (GDS-K) to 733 community-dwelling elderly aged 50 or over in three districts of Suwon. The differences between the MMSE-KC scores and K-MMSE scores were examined by repeated measure ANOVA computing the MMSE for intra-individual factor, age, gender, and educational level as inter-individual factor, and GDS-K score as a covariate. RESULTS: The scores of MMSE-KC and K-MMSE were identical only in the 17.8% of the subjects and the difference between the MMSE-KC score and K-MMSE score were significantly influenced by the educational level of the subjects (F (3,173)=8.21, p0.1), it was highly significant in 'judgement and writing/reading' subscores (F (1,731)=16.35, p<0.001) and its influences were significantly varied by the educational level of the subjects (F (1,731)=20.82, p<0.001). CONCLUSION: The MMSE-KC and K-MMSE which were standardized differently are not identical in scores as well as in content, and the difference between the two is greatly influenced by the educational level of the subject. When interpreting or comparing the MMSE scores of the two different versions of Korean MMSE, the comparability of the scores among them observed in this study should be considered.