Historical Tracing and Textual Research on Ancient Classic Formula Zhenwutang / 中国实验方剂学杂志

ZHANG Zhongjing's Zhenwutang is a classic formula for warming Yang and excreting water. It is composed of Aconiti Lateralis Radix Praeparata， Poria， Atractylodis Macrocephalae Rhizoma， Paeoniae Radix Alba， and Zingiberis Rhizoma Recens. Physicians of later generations have inherited and developed this formula by detailed recording and application. This paper adopted bibliometrics method to analyze Zhenwutang in terms of history， indications， dosage， drug processing， usage， and modification. The results showed that Zhenwutang was most widely used in Ming and Qing dynasties. Many physicians have inherited ZHANG Zhongjing's theory regarding the application of Zhenwutang in disease treatment， and a few physicians have used it to treat diphtheria and water-related diseases. Some physicians modified this formula to treat maculae， intermittent dysentery， jaundice and so on. Zhenwutang was mainly used to treat diseases of the circulatory system， respiratory system and urinary system in modern clinical practice. The processing of herbal medicines in this formula was clear. Specifically， the raw material of Aconiti Lateralis Radix Praeparata needed to be processed and peeled， while those of Poria， Atractylodis Macrocephalae Rhizoma， Paeoniae Radix Alba， and Zingiberis Rhizoma Recens can be used directly. Although being different， most of the dosages were consistent with those in Treatise on Febrile Diseases. According to the textual research， it is suggested that the reference dosage of this prescription in clinical practice is 41.25 g for Poria， Paeoniae Radix Alba， and Zingiberis Rhizoma Recens， respectively， 27.5 g for Atractylodes macrocephala， and 15 g for Aconiti Lateralis Radix Praeparata. The medicinal materials should be decocted in 1 600 mL water to reach a volume of 600 mL. After removal of the residues， the decoction should be taken warm with 140 mL each time， three times a day. The textual research of Zhenwutang is expected to provide a theoretical reference for the clinical application and formulation of Zhenwutang.

Data-driven engineering framework with AI algorithm of Ginkgo Folium tablets manufacturing

Smart manufacturing still remains critical challenges for pharmaceutical manufacturing. Here, an original data-driven engineering framework was proposed to tackle the challenges. Firstly, from sporadic indicators to five kinds of systematic quality characteristics, nearly 2,000,000 real-world data points were successively characterized from Ginkgo Folium tablet manufacturing. Then, from simplex to the multivariate system, the digital process capability diagnosis strategy was proposed by multivariate Cpk integrated Bootstrap-t. The Cpk of Ginkgo Folium extracts, granules, and tablets were discovered, which was 0.59, 0.42, and 0.78, respectively, indicating a relatively weak process capability, especially in granulating. Furthermore, the quality traceability was discovered from unit to end-to-end analysis, which decreased from 2.17 to 1.73. This further proved that attention should be paid to granulating to improve the quality characteristic. In conclusion, this paper provided a data-driven engineering strategy empowering industrial innovation to face the challenge of smart pharmaceutical manufacturing.

Application and optimization of batch number traceability management mode in intelligent anesthesia pharmacy of operating room / 中国药房

OBJECTIVE To establish a drug batch number traceability management mode in intelligent anesthesia pharmacy of operating room， improve the management level of batch number traceability in anesthesia pharmacy of operating room and ensure the safety of surgical medication. METHODS The problems encountered in the application of batch number traceability management mode in intelligent anesthesia pharmacy of operating room were analyzed to implement the optimization measure and summarize the optimization effect. RESULTS In view of the incompatibility of multiple batch numbers on the dosing track， the insufficient number of drugs in the automated dispensing cabinet， the long replenishment time， the low stability of the automated dispensing cabinet， and the tedious management of drugs with a near-expiration period， the following measures were implemented， including changing the minimum unit of dosing， adjusting the drug base number and surgery schedule， optimizing the supplementary drug delivery order， repairing dosing tracks of the automated dispensing cabinet， adding the batch number correction function， improving the screening function of drugs with a near-expiration period， and configuring the automated dispensing cabinet in the recovery room. It realized the coexistence of multiple batch numbers on the dosing track， the sufficient number of drugs in the automated dispensing cabinet， the shortening of the replenishment time， the improvement in the stability of the automated dispensing cabinet， and the efficient management of drugs with a near-expiration period. CONCLUSIONS The batch number traceability management mode is established in intelligent anesthesia pharmacy of operating room in our hospital， which improves the system function module， optimizes the work process， increases the stability of the automated dispensing cabinet， improves the work efficiency， and realizes the refined management of surgical medication.

Traceability of syphilis antibody detection in preserved samples / 中国输血杂志

【Objective】 To investigate whether the current retention methods in blood stations can fully meet the traceability requirements of blood test results by analyzing the traceability of retained samples for syphilis antibody testing. 【Methods】 Thirty-four one-assay-positive deep-well plate retention samples, 68 double-assay-positive deep-well plate retention samples and 263 negative retention blood braids and corresponding deep-well plate retention samples that expired retention period for syphilis antibody testing from 2014 to 2020 in our center were collected. The TP-ELISA assays of two manufacturers were used for retesting, and the results were recorded and compared with the original results statistically. 【Results】 The concordance rate of the double-assay-positive and single-assay-positive samples with their corresponding deep-well plate samples was 98.53%(67/68) and 67.65%(23/34), respectively(P<0.05). Specific results for single-assay-positive syphilis antibody samples and their corresponding deep-well plate retention samples were as follows: 1) Single positive (reagent A): 13 out of 14 original samples were 0.65

Desafios dos laboratórios públicos da área de saúde ambiental para implantação e manutenção dos requisitos de normativas da qualidade para monitoramento da água de consumo humano / Challenges for public laboratories in the environmental health area for implementation and maintenance of quality regulatory requirements for monitoring human consumption water

Resumo Introdução O Ministério da Saúde (MS) é responsável pela vigilância da qualidade da água de consumo humano. A confiabilidade nos resultados do monitoramento de parâmetros analíticos minimiza riscos à saúde pública. Objetivo Retratar aspectos funcionais, a aplicação de ferramentas da qualidade e a aderência dos laboratórios públicos que atuam no monitoramento da água de consumo humano aos requisitos da norma ABNT NBR ISO/IEC 17025. Método A pesquisa foi realizada com 30 laboratórios públicos de todas as regiões do país, respondendo a um questionário elaborado com 49 perguntas sobre a formação e capacidade dos profissionais, garantia da validade dos resultados e sobre a determinação de parâmetros da qualidade da água. Resultados Dos 161 profissionais, 46% possuem mais de 10 anos de experiência e 65% têm formação superior. Capacitações específicas foram requeridas por todos. A validação dos métodos analíticos não foi realizada por 59%. Materiais de referência certificados são acessados por 41% e apenas 18% têm facilidade em adquiri-los. A participação em ensaios de proficiência foi reportada por 68% dos laboratórios, mas com poucos parâmetros avaliados e dificuldades em contratar provedores. Conclusão Evidenciou-se a necessidade de ações para fortalecimento da metrologia em laboratórios públicos que atuam na vigilância da qualidade da água.

Abstract Background The Ministry of Health (MS) is responsible for drinking water quality surveillance. Reliability in the results of monitoring analytical parameters minimizes public health risks. Objective To present functionals aspects and the application of quality tools by public laboratories that work to monitor the quality of drinking water. Method A survey was conducted with 30 public laboratories from all regions of the country, answering a questionnaire elaborated with 49 questions about the training and capacity of professionals, guaranteeing the validity of the results and about the determination of basic parameters of water quality. Results Of the 161 professionals, 46% have more than 10 years of experience and 65% have higher education. Specific training was required by everyone. The validation of the analytical methods was not performed by 59%. Reference materials are accessed by 41% and only 18% can acquire them easily. Participation in proficiency tests was reported by 68% of the laboratories, but with few parameters evaluated and difficulties in hiring providers. Conclusion The need for actions to strengthen metrology in public laboratories that work in water quality surveillance was highlighted.

La trazabilidad en las mediciones del laboratorio clínico: impacto en la calidad y seguridad del paciente / Traceability in clinical laboratory measurements: impact on quality and patient safety

Las mediciones confiables, trazables metrológicamente y comparables proporcionan la base racional para la evaluación de la calidad de un resultado y el fortalecimiento de las redes de laboratorios clínicos, lo cual permite mejorar la calidad de atención y la seguridad del paciente. En este documento se revisan los principios básicos que deben seguirse para garantizar la trazabilidad de las mediciones del laboratorio clínico, las ventajas de utilizar métodos trazables, el impacto de no hacerlo, y se discuten las principales limitaciones para relacionar las mediciones con los estándares de medición de referencia apropiados

Reliable, metrologically traceable, and comparable measurements provide the rationale for evaluating the quality of a result and strengthening clinical laboratory networks, thereby improving quality of care and patient safety. This document reviews the basic principles that must be followed to ensure the traceability of clinical laboratory results, the advantages of using traceable methods, the impact of not doing so, and the main limitations in relating measurements to appropriate reference standards

Discussion on Technical Evaluation Requirements of Allergen Detection Reagent Pre-marketing / 中国医疗器械杂志

In the perspective of technical evaluation, the pre-marketing regulatory requirements of allergen detection reagents in China, America, European Union were compared, and the regulatory risks and performance requirements of this product were analyzed based on the monitoring of post-marketing adverse events, reference standards and domestic and foreign regulatory documents. In view of the "neck-stuck" problems such as the difficulty of clinical trials, the difficulty of finding comparable contrast reagents and the lack of clinical diagnostic gold standards, this paper discusses and gives regulatory suggestions, with a view to providing technical reference for product R&D, production, evaluation, approval and supervision in this field.

Epidemiological characteristics and transmission chain of COVID-19 in Harbin in January 2021 / 中华地方病学杂志

Objective:To observe the epidemiological characteristics and transmission chain of COVID-19 in Harbin, and to provide epidemiological evidence for improving the COVID-19 preventive measures and optimizing prevention and control strategies.Methods:The epidemic situation of COVID-19 in Harbin in January 2021 was analyzed by using the Infectious Disease Report Information Management System and the Public Health Emergency Management Information System of the China Disease Prevention and Control Information System, the epidemic situation information publicly released by the Heilongjiang Provincial Health Commission, and the epidemiological report of Heilongjiang Province Certer for Disease Control and Prevention and Harbin Center for Disease Control and Prevention. The main transmission chains were sorted out through combination of epidemiological field investigation, serological testing, gene sequencing, big data and other means.Results:From January 12 to February 4, 2021, 295 cases of COVID-19 infection (including confirmed cases and asymptomatic infections) were reported in Harbin, which affected 6 districts of Harbin and were concentrated in 41 of the 274 townships in the city. The sex ratio of male to female was 1.00∶1.12 (139∶156); the age ranged from 1 to 86 years old, and the median age was 45 years old. The proportion of confirmed cases and asymptomatic infection was 1.00 ∶ 1.02 (146 ∶ 149), and there was a significant difference in the distribution of different ages between them ( P = 0.042). The cases were mainly found through the health screening of the centralized isolation personnel (178 cases, 60.3%). Other detection methods included active screening (87 cases, 29.5%), screening of the home isolation personnel (26 cases, 8.8%), and medical treatment in medical institutions (4 cases, 1.4%). The main transmission chain of the outbreak was the case associated with a food processing enterprise, with a total of 259 cases, accounting for 87.8% of the total cases. The gene sequencing results showed that the case sequence was homologous with that of Wangkui County, Suihua City, Heilongjiang Province. Conclusions:A food processing enterprise is involved in the main transmission chain, which indicates that the epidemic prevention and control measures needs to be further optimized. Specifically, the supervision and management of food processing enterprises, cold chain storage companies and other enterprises should be strengthened. High attention should be paid to the hidden dangers of COVID-19 in large and medium sized enterprises with hermetic space in Harbin.

Sistema de trazabilidad aplicado a la producción de semilla bajo el esquema de mínimos para cultivos semestrales en los valles interandinos / Traceability system applied to seed production under the minimum scheme for semi-annual crops in the inter-Andean valleys

RESUMEN La semilla es el insumo principal para el establecimiento de sistemas productivos agrícolas, por lo cual, durante la producción de semilla, una condición indispensable es que se mantenga la calidad del material en todo el proceso incremental. El Departamento de Semillas de la Corporación Colombiana de Investigación Agropecuaria-Agrosavia, comprometido con el cumplimiento de los requisitos establecidos en la Resolución ICA 3168 de 2015 y en el Decreto del MADR 931 de 2018, en todos sus procesos productivos, ha desarrollado e implementado un Sistema Interno de Trazabilidad (SIT) para la producción de semilla y, específicamente, en una de sus estrategias denominada Plan de Mínimos para cultivos semestrales soya, algodón, arroz, maíz y sorgo en los valles interandinos. Los resultados mostraron que esta herramienta tecnológica facilitó, en el proyecto, realizar el monitoreo y el seguimiento de las labores, el registro de eventos climáticos, el manejo eficiente de inventarios y el análisis de costos. Esta reflexión es un trabajo pionero en Colombia, que contribuye a la toma de decisiones, a mejorar la productividad y a fortalecer el Sistema Nacional de Semillas.

ABSTRACT Seed is the main input for the establishment of agricultural production systems, so during seed production an indispensable condition is that the quality of the material is maintained throughout the incremental process. The Seed Department of Colombian Agricultural Research Corporation- Agrosavia, committed to complying with the requirements established in Resolution ICA 3168 of 2015 and Decree MADR 931 of 2018in all its production processes, has developed and implemented an Internal Traceability System (SIT) for the production of seed and specifically in one of its strategies called Minimum Plan for semi-annual crops of soybean, cotton, rice, corn and sorghum in the inter-Andean valleys. The results show that this technological tool facilitated in the project carried out the monitoring and tracing of the crops work, the registry of climatic events, the efficient management of inventories and the analysis of costs. This is a pioneering work in Colombia, which contributes to decision making, improve productivity and strengthen the National Seed System.

Management system and development strategy of quality Chinese medicine / 中国中药杂志

The development of quality Chinese medicine is an important way to improve the quality of Chinese medicine, and ensure the safety and effectiveness of Chinese medicine. This article systematically elaborates the definition, classification, standard and mana-gement certification strategy of quality Chinese medicine. We present the quality Chinese medicine which is higher quality than that of eligible Chinese medicine based on quality control standards. Quality Chinese medicine is strictly in accordance with management procedures, likely GAP and GMP et al, during the productive process, which quality indicators is higher than that of the current relevant national quality standards, such as Chinese Pharmacopoeia(ChP) et al; its limited indicators such as exogenous pollutants and endogenous toxic substances are lower than that of the current relevant national quality standards, likely ChP et al; meanwhile these Chinese herbal medicine, medicinal pieces, patent medicines, and health products and foods with Chinese medicine raw materials are been certificated by quality Chinese medicine. At the same time, this article systematically expounds the five major management systems of quality Chinese medicine, including technical training management for practitioners, productive process management, standard mana-gement, quality inspection and certification management, and product traceability management. And we put forward strategies to improve the supervision and management system, and promote the standardization and development of quality Chinese medicine by improving the technical management system of quality Chinese medicine, strengthening the quality management system and six sigma(6σ) management in the company. These strategies will provide a reliable basis and effective way to improve the quality of Chinese medicine.

Research on Visualized Traceability Supervision System of Medical Equipment Based on Wireless Local Area Network Real-time Positioning System / 中国医疗器械杂志

Aiming at the shortcomings of traditional medical device tracking and supervision mode, such as delayed feedback of medical device positioning information, poor visual tracking effect of medical device, and missing early warning of medical device working state supervision, a medical device visual tracking and supervision system based on wireless Local Area Network (LAN) real-time positioning system is developed. Introduction of wireless LAN real-time positioning system, using standard coding algorithm generating device object ID tags, with the only attribute based on RFID read-write terminal complete physical mapping of medical equipment and material ID label, we realize a real-time positioning and traceability of medical equipment, with the help of active warning algorithm based on depth of learning medical equipment working state supervision for early warning, with the help of indoor map generation and trajectory playback medical equipment to realize visualization back regulation. Choose equipment of hospital of Linyi Central Hospital for performance evaluation of the carrier, the evaluation model of engineering practice and clinical statistical analysis, the results show that the system has a complete real-time positioning, visible trace, abnormal warning function. In medical equipment real-time positioning information visual tracing feedback, abnormal state warning etc, medical equipment has obvious advantages.

Thoughts and Suggestions on Review of Autoimmune Test Reagents / 中国医疗器械杂志

In this paper, some significant problems, which were found frequently in the products of autoimmune

Design and Implementation of Quality and Safety Traceability System for Reusable Medical Devices Disinfection Based on RFID Technology / 中国医疗器械杂志

Focusing on the requirements of visual traceability for reprocessing of reused medical devices under the background of deep integration of intelligent medical treatment, a quality and safety traceability system for disinfection of reused medical devices is developed. The multi-dimensional data of the reprocessing chain of reusable medical devices are acquired in real time by the RFID mobile terminal handset and stored temporarily. The data package is formatted based on LoRa protocol and uploaded to the management and control platform in multi-threaded transmission mode for in-depth analysis and traceability. The corresponding prototype system is developed. The first-line operation and maintenance test results show that the prototype system has strong cooperation, strong operation robustness, and obvious advantages in the identification rate and other layers of sterile equipment package.

Considerations from FDA Food Traceability to Chinese Medicinal Materials Traceability / 中国实验方剂学杂志

As a Chinese saying goes， "good Chinese medicinal material makes good medicine"， the traceability of Chinese medicinal materials is closely related to the high-quality development of Chinese medicine industry. This article intends to analyze the "new era of smarter food safety blueprint" and Proposed Rule for Food Traceability related to food traceability of the U.S. Food and Drug Administration （FDA）， including food traceability list， critical tracking events， and examples of exemptions. By studying the process and consideration of the construction of the FDA food traceability system， as well as the specific traceability requirements of fresh herbs， vegetables and fruits in the FDA food traceability system that are related to Chinese medicinal materials， on the one hand， it provides research materials for the communication and discussion of Chinese medicinal materials traceability， on the other hand， it also provides reference for the construction of food traceability system in China. To sort out the idea of constructing a traceability system for Chinese medicinal materials suitable for the current development status of traditional Chinese medicine， the contents to be considered are as follows：①To determine the traceability list of Chinese medicinal materials based on the risk control of Chinese medicinal materials. ②Determine the critical tracking links and information in the Chinese medicinal materials industry chain， and standardize the traceability information of Chinese medicinal materials. ③The quality information of Chinese medicinal materials should be reflected in the traceability of Chinese medicinal materials. ④Within the scope of the traceability list of Chinese medicinal materials， enterprises should be encouraged to make voluntary traceability by selecting Chinese medicinal materials with a good foundation of traceability work.

Origin traceability of main root of spring Panax notoginseng based on stable isotope fingerprint / 中国中药杂志

This paper established the identification technology of the main root origin of three-year-old spring Panax notoginseng aiming at providing theoretical basis for the protection and traceability of geographical indication products of P. notoginseng. Forty-four samples of three-year-old spring P. notoginseng from Guangxi Baise, Yunnan Wenshan, Yunnan new cultivating regions. The stable isotopic ratios of carbon, nitrogen, hydrogen and oxygen were determined by elemental analysis and stable isotope mass spectrometer. Combined with Duncan multiple comparative analysis, fisher discriminant analysis and sequential discriminant analysis, a origin discriminant model for the main root of three-year-old spring P. notoginseng was established for 3 production areas of P. notoginseng. The geographical climate and environment of three production areas of P. notoginseng are obviously different. From Guangxi Baise-Yunnan Wenshan-Yunnan new cultivating regions, the longitude, average annual temperature and annual precipitation gradually decrease, and the elevation and latitude are increasing. The results of multiple comparative analysis showed that there were significant or very signi-ficant differences in the δ~(13)C,δ~(15)N,δ~2H,δ~(18)O of the main roots of P. notoginseng in three regions. The results of fisher's discriminant analysis and sequential discriminant analysis showed that the correct discriminant rates of the main roots of P. notoginseng for three regions were 80.05%,76.47% and 90.91%, respectively, based on four stable isotope ratios, with an average of 84.09%. Using stable isotope fingerprint and chemometrics method, we can distinguish the origin of the main raw materials and products of P. notoginseng.

An integrated spectroscopic strategy to trace the geographical origins of emblic medicines:Application for the quality assessment of natural medicines / 药物分析学报

Emblic medicine is a popular natural source in the world due to its outstanding healthcare and therapeutic functions. Our preliminary results indicated that the quality of emblic medicines might have an apparent regional variation. A rapid and effective geographical traceability system has not been designed yet. To trace the geographical origins so that their quality can be controlled, an integrated spectroscopic strategy including spectral pretreatment, outlier diagnosis, feature selection, data fusion, and machine learning algorithm was proposed. A featured data matrix (245 × 220) was successfully generated, and a carefully adjusted RF machine learning algorithm was utilized to develop the geographical traceability model. The results demonstrate that the proposed strategy is effective and can be generalized. Sensitivity (SEN), specificity (SPE) and accuracy (ACC) of 97.65％, 99.85％ and 97.63％ for the calibrated set, as well as 100.00％ predictive efficiency, were obtained using this spectroscopic analysis strategy. Our study has created an integrated analysis process for multiple spectral data, which can achieve a rapid, nondestructive and green quality detection for emblic medicines originating from seventeen geographical origins.

Application of DNA barcoding technology in the whole industrial chain of traditional Chinese medicine / 药学学报

DNA barcoding technology, a method of identifying biological species through a standard sequence, is widely used in the identification of traditional Chinese medicine (TCM), promoting the renaissance of TCM authentication discipline. The whole industrial chain of TCM includes three sections: the planting and collecting in the upstream chain, the production of TCM in the midstream chain and the circulation in the downstream chain. DNA barcoding technology, which possesses accurate, common, and objective advantages, plays an important role in the whole industrial chain of TCM. In the upstream, it is used to identify the seeds, seedlings and medicinal plants, ensuring the original source is correct. In the middle, it is used to identify Chinese medicinal materials, Chinese herbal slices and Chinese patent medicines, ensuring the materials of enterprises are correct and the clinical medication is safe. In the downstream, it participates in the establishment of traceability system for TCM, achieving the recording, inquiry and traceability of information. Therefore, DNA barcoding technology should help to control the whole production process, to protect the rights and interests of consumers and contribute to the supervision of TCM. Combined with some study cases in recent years, this paper introduces the application of DNA barcoding technology in the whole industrial chain of TCM, which is of great significance to promote the modernization of TCM industry and their internationalization.

Application of traditional Chinese medicine(TCM) traceability system based on TCM quality characteristics and HACCP system / 中国中药杂志

It is crucial to establish a complete set of traditional Chinese medicine(TCM) quality traceability management process system, in order to stabilize the pricing order of TCM market and reconstruct the transmission path of TCM quality signals. In this study, we reviewed the mature experience of food and drug supervision at home and abroad, analyzed the quality characteristics of TCM, and put forward that the quality control of TCM products can learn from the hazard analysis and critical control point(HACCP) system in food safety quality control. This study points out that the HACCP system provides not only technical guidance for the traceability management of TCM, but also ideas for improving the quality of TCM products and the safety risk control of TCM. The application of the HACCP system in TCM quality control can help establish an international dialogue platform for TCM and help realize the modernization and internationalization of TCM industry.

Desarrollo de un material de referencia certificado para análisis elemental de agua potable / Development of a certified reference material for elemental analysis of drinking wáter / Desenvolvimento de um material de referência certificado para análise elementar de água potável

Resumen La producción de un material de referencia (MR) es un proceso en el que se realizan estudios relacionados con la preparación, envasado y caracterización (incluye homogeneidad y estabilidad). En este trabajo se presentan los resultados del desarrollo de un MR de agua potable. El envasado se realiza aplicando dos procedimientos (envasado convencional e inmersión). La caracterización se realizó por Absorción Atómica, ICPMS y Cromatografía iónica. La evaluación de homogeneidad del material se realizó para Na, Mg, Ca, Fe, K, Co, Pb, Mo, As, Ni, Se, Cu, Al, Cr Zn y aniones como NO3 - y Cl-. La estabilidad se evaluó a corto (condiciones aceleradas) y largo plazo por ICPMS y CI, además se realizó seguimiento gravimétrico. La homogeneidad y estabilidad se evaluaron con base en su incertidumbre. La incertidumbre asociada a la homogeneidad y estabilidad MR evidenció resultados aceptables para la mayoría de los analitos. Los resultados del seguimiento gravimétrico permitieron detectar pérdidas de masa del material, por lo que se planteó un nuevo esquema para evaluar la estabilidad a través de métodos gravimétricos. Finalmente, se encontró que el MR presenta incertidumbres expandidas entre el 0,93% y el 4,38%, siendo apto para el uso previsto.

Abstract The production of reference materials (RM) is a process that involves carrying out different studies related to the preparation, packaging and chemical stability of the analytes. This paper presents the results of the development of a drinking water RM. The packaging is done by applying two procedures (conventional packaging and immersion). The characterization of this material was carried out through atomic absorption, ICPMS and ion chromatography. The assessment of the homogeneity of the material was carried out for Na, Mg, Ca, Fe, K, Co, Pb, Mo, As, Ni, Se, Cu, Al, Cr Zn and anions as NO3 - y Cl-. The stability studies were evaluated in the short term (accelerated conditions), and long term by ICPMS and IC, and gravimetric monitoring was also performed. Homogeneity and stability were evaluated based on their uncertainty. The uncertainty associated with homogeneity and MR stability evidenced acceptable results for most analytes. The results of the gravimetric monitoring allowed to detect losses of mass of the material, reason why a new scheme was proposed to evaluate the stability through gravimetric methods. Finally, it was found that the RM presents expanded uncertainties between 0,93% and 4,38%, which makes it suitable for the intended use.

Resumo Este artigo apresenta os resultados do desenvolvimento de um MR de água potável. A embalagem é feita aplicando dois procedimentos (embalagem convencional e imersão). A caracterização foi realizada por Absorção Atômica, ICPMS e Cromatografia Iônica. A avaliação da homogeneidade do material foi realizada para Na, Mg, Ca, Fe, K, Co, Pb, Mo, As, Ni, Se, Cu, Al, Cr Zn e ânions como NO3 - y Cl-. A estabilidade foi avaliada em curto prazo (condições aceleradas) e em longo prazo pelo ICPMS e IC, e também foi realizada monitoração gravimétrica. A homogeneidade e estabilidade foram avaliadas com base na incerteza. A incerteza associada à homogeneidade e estabilidade da RM evidenciou resultados aceitáveis para a maioria dos analitos. Os resultados do monitoramento gravimétrico permitiram detectar perdas de massa do material, pelo que foi proposto um novo esquema para avaliar a estabilidade por métodos gravimétricos. Por fim, verificou-se que o RM apresenta incertezas expandidas entre 0,93% e 4,38%, sendo adequado para o uso pretendido.

EQA-based evaluation of metrological traceability of clinical chemistry test results in Argentina / EQA-based evaluation of metrological traceability of clinical chemistry test results in Argentina

Equivalence of results among laboratories is a major mission for medical laboratories. In the Netherlands, medical laboratories only use homogenous, commercial for general chemistry analytes, whereas in Argentina heterogenous, home brew test applications are common. The effect of this practice difference on test accuracy is studied using key features of the accuracy-based EQA program of the Netherlands. Six frozen, human-based, commutable poolsera, covering the (patho) physiological measuring range for 17 general chemistry analytes, were assayed by ~75 Argentinian labs and ~200 Dutch laboratories in 2014. After removal of outliers, harmonization status among laboratories was evaluated by calculating overall mean interlaboratory coefficients of variation (CVs, %) per analyte and per country for all 6 levels. Evenso, standardization status was evaluated after removal of outliers by calculating overall mean recoveries (%) as compared to the assigned target values per analyte per country for all 6 levels. Absolute median biases were compared to (minimal/desirable) biases derived from biological variation criteria. For serum enzymes interlaboratory CVs in the Argentinian laboratories ranged between 10 and 22%, as compared to 3-6% in the Netherlands. For serum uric acid, creatinine, glucose and total protein, interlaboratory CVs varied between 4.3 and 13.1% in Argentinian labs, as compared to <3.5% in the Netherlands. For serum electrolytes, interlaboratory CVs ranged between 1.8 and 3.8% for Na+; 2.9-5.8% for Cl-; 3.8-7.5% for K+; 9.4-10.4% for Ca2+ and 16.2-22.3% for Mg2+ as compared to ≤2% (Na+, K+, Cl-, Ca2+) and ≤3% (Mg2+) in the Netherlands. Mean recoveries in Argentinian laboratories for e.g. serum creatinine, glucose, CK, Ca2+ and Na+ were 95-119%; 95-104%; 98-102%; 98-102% and 96-100% respectively, whereas min-max recovery ranges were 65-155%; 58-126%; 47-132%; 66-132% and 85-115%. In the Netherlands, absolute mean recoveries were overall 98.9% with a SD of 2.0%. Median biases in Argentinian laboratories ranged from -2.9 to 18.2%; -3.1 - 2.6%; -3.3 - 0.5%; -1.1 - 3.8% and -4.3-0% for serum creatinine, glucose, CK, Ca2+ and Na+. In the Netherlands overall mean/median biases were 1.1% (SD=2.0%). Exchange of commutable, value- assigned EQA-materials was helpful for studying the harmonization and standardization status of medical tests in Argentina, and for revealing the future harmonization and standardization potential. The results clearly demonstrate that metrological traceability of test results in Argentina is on average in line with what is expected; yet, the spreading among laboratories is far too high and should be improved.

La equivalencia de resultados entre laboratorios es una mision importante para los laboratorios medicos. En los Paises Bajos, los laboratorios medicos solo usan aplicaciones comerciales homogeneas, regulatoriamente aprobadas (CE-IVD) para analitos quimicos, mientras que en la Argentina son comunes las aplicaciones heterogeneas caseras. El efecto de esta diferencia practica en la precision de la prueba se estudia utilizando caracteristicas clave del programa EQA, basado en la precision, de los Paises Bajos. Se ensayaron seis pools de sueros, congelados, de origen humano, conmutables, que cubrian el rango de medidas (pato)fisiologicas para 17 analitos de quimica clinica. Estos analitos de quimica clinica fueron analizados por ~75 laboratorios argentinos y ~200 laboratorios holandeses en 2014. Despues de eliminar los valores atipicos, el estado de armonizacion entre los laboratorios fue evaluado calculando los coeficientes de variacion interlaboratorios medios globales (CV%) por analito y por pais para los 6 niveles. No obstante, el estado de estandarizacion se evaluo despues de la eliminacion de valores atipicos mediante el calculo de recuperaciones medias generales (%) en comparacion con los valores asignados por analito por pais para los 6 niveles. Los sesgos medios absolutos se compararon con los sesgos (minimos / deseables) derivados de los criterios de variacion biologica. Para enzimas sericas los CV interlaboratorio en los laboratorios argentinos oscilaron entre 10 y 22%, en comparacion con 3-6% en los Paises Bajos. Para el acido urico serico, creatinina, glucosa y proteinas totales, los CV entre laboratorios variaron entre 4,3 y 13,1% en los laboratorios argentinos, en comparacion con <3,5% en los Paises Bajos. Para los electrolitos sericos, los CV interlaboratorios oscilaron entre 1,8 y 3,8% para Na+; 2,9-5,8% para Cl-; 3,8-7,5% para K+; 9,4-10,4% para Ca2+ y 16,2-22,3% para Mg2+ en comparacion a ≤2% (Na+, K+, Cl-, Ca2+) y ≤3% (Mg2+) en los Paises Bajos. Las recuperaciones medias en laboratorios argentinos para, p.ej. la creatinina serica, glucosa, CK, Ca2+ y Na+ fueron 95-119%; 95-104%; 98-102%; 98-102% y 96-100% respectivamente, mientras que los rangos de recuperacion min-max fueron 65-155%; 58-126%; 47-132%; 66-132% y 85-115%. En los Paises Bajos, las recuperaciones medias absolutas fueron en general del 98,9% con una desviacion estandar (DE) del 2,0%. La mediana de los sesgos medios de los laboratorios argentinos oscilo entre -2,9 y 18,2%; -3,1 - 2,6%; -3,3 - 0,5%; -1,1 - 3,8% y -4,3-0% para creatinina serica, glucosa, CK, Ca2+ y Na+. En los Paises Bajos, las medias / medianas en general fueron de 1,1% (DE=2,0%). El intercambio de los valores asignados a los materiales EQA, conmutables fue de gran ayuda para la armonizacion y estandarizacion de los ensayos medicos en la Argentina y para revelar el potencial futuro de armonizacion y estandarizacion. Estos resultados claramente demuestran que la trazabilidad metrologica de los resultados de las pruebas en la Argentina esta, en promedio, de acuerdo con lo esperable; sin embargo, la dispersion entre laboratorios es muy grande y deberia ser mejorada.

A equivalencia de resultados entre laboratorios e uma missao importante para os laboratorios medicos. Nos Paises Baixos, os laboratorios medicos so utilizam aplicacoes comerciais homogeneas, aprovadas por regulacoes (CE-IVD) para analitos quimicos, ao passo que na Argentina sao comuns as aplicacoes heterogeneas caseiras. O efeito desta diferenca pratica na exatidao do teste e estudado utilizando caracteristicas essenciais do programa EQA, dos Paises Baixos, baseado na exatidao. Foram ensaiados seis pools de soros, congelados, de origem humana, comutaveis, que abrangiam a faixa de medidas (pato)fisiologicas para 17 analitos quimicos gerais. Esses analitos quimicos foram analisados por ~75 laboratorios argentinos e ~200 laboratorios holandeses em 2014. Apos eliminar os valores atipicos, o estado de harmonizacao entre os laboratorios foi avaliado atraves do calculo dos coeficientes de variacao interlaboratorio meios globais (CV%) por analito e por pais para os 6 niveis. Nao obstante, o estado de padronizacao foi avaliado depois da eliminacao de valores atipicos pelo calculo de recuperacoes medias gerais (%) se comparados com os valores atribuidos por analito por pais para os 6 niveis. Os vieses medios absolutos foram comparados com os vieses (minimos / desejaveis) decorrentes dos criterios de variacao biologica. Para enzimas sericas, os CV interlaboratorio nos laboratorios argentinos oscilaram entre 10 e 22%, em comparacao com 3-6% nos Paises Baixos. Para o acido urico serico, creatinina, glicose e proteinas totais, os CV entre laboratorios variaram entre 4,3 e 13,1% nos laboratorios argentinos, em comparacao com <3,5% nos Paises Baixos para os eletrolitos sericos, os CV interlaboratorios oscilaram entre 1,8 e 3,8% para Na+; 2,9-5,8% para Cl-; 3,8-7,5% para K+; 9,4-10,4% para Ca2+ e 16,2-22,3% para Mg2+ em comparacao com ≤2% (Na+, K+, Cl-, Ca2+) e ≤3% (Mg2+) nos Paises Baixos. As recuperacoes medias em laboratorios argentinos para, p.ex. a creatinina serica, glicose, CK, Ca2+ e Na+ foram 95-119%; 95-104%; 98-102%; 98-102% e 96-100% respectivamente, enquanto que os intervalos de recuperacao min-max. foram 65-155%; 58-126%; 47-132%; 66-132% e 85-115%. Nos Paises Baixos, as recuperacoes medias absolutas foram em geral de 98,9% com um desvio padrao (DE) de 2,0%. A mediana dos vieses medios dos laboratorios argentinos oscilou entre -2,9 e 18,2%; -3,1 - 2,6%; -3,3 - 0,5%; -1,1 - 3,8% e -4,3-0% para creatinina serica, glicose, CK, Ca2+ e Na+. Nos Paises Baixos, as medias / medianas em geral foram de 1,1% (DE=2,0%). O intercambio dos valores atribuidos aos materiais EQA, comutaveis, foi de grande ajuda para a harmonizacao e padronizacao dos ensaios medicos na Argentina e para revelar o potencial futuro de harmonizacao e padronizacao. Esses resultados demonstram as claras que a rastreabilidade metrologica dos resultados dos testes na Argentina esta de acordo com o esperavel; a dispersao entre laboratorios ainda e muito grande e deveria ser melhorada.