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Resumen Los programas de estandarización de creatinina mantienen su vigencia. El objetivo es describir la experiencia adquirida durante el desarrollo de un programa de estandarización de creatinina en una provincia de bajos recursos y mostrar los aspectos que se deben considerar para su escalabilidad en un contexto semejante. El programa se desarrolló en etapas: en la primera (2010) se realizó el relevamiento de 49 laboratorios clínicos (LC) distribuidos en toda la provincia del Chaco, Argentina. En la segunda (2012) se ajustó el error aleatorio (EA) aplicando protocolos internacionales (CLSI EP-5A). En la tercera etapa (2014-2015) se procesaron paneles de sueros con concentraciones asignadas por un método trazable al de referencia y al estándar internacional (CG-IDMS). Se aplicaron protocolos internacionales para evaluar el error total (ET) de la determinación en cada laboratorio (CLSI EP-10A). En 2016, aplicando herramientas de calidad, se evaluaron las barreras en el proceso. Se observó en el EA: para un nivel de 1,00 mg/dL, ningún LC alcanzó los niveles deseables; para un nivel de 2,5 mg/dL solo 9 (23%) los alcanzaron. Concluida la segunda y tercera etapa, solo 18 laboratorios (48,7%) lograron ajustar el EA y/o ET, pero resultó dificultoso sostenerlo en el tiempo. Los reactivos, calibradores y controles son producidos por la industria y depende del estado el control de los mismos. La homogeneidad del equipamiento depende de la accesibilidad económica y del volumen de trabajo. El medio ambiente, la temperatura y la calidad del agua siguen siendo una dificultad para la escalabilidad.
Abstract Creatinine standardisation programmes remain valid. The objective of this work is to describe the experience acquired during the development of a creatinine standardisation programme in a low-resource province and show the aspects that should be considered for its scalability in a similar context. The programme was developed in stages. The first one was carried out in 2010. It consists of a structured survey completed by 49 clinical laboratories (CL) distributed throughout the province. In the second stage (2012) the random error (RE) was adjusted by applying international protocols (CLSI EP-5A). In the third stage (2014-2015), panels of sera were processed with concentrations assigned by a method traceable to the reference and the international standard (CG-IDMS). International protocols were applied to evaluate the total error (TE) of the determination in each laboratory (CLSI EP-10A). In 2016, applying quality tools, the barriers in the process were evaluated. In the RE, it was observed: for a level of 1.00 mg/dL, no CL reached the desirable levels; for a level of 2.5 mg/dL only 9 (23%) CL achieved them. Once the second and third stages were completed, only 18 laboratories (48.7%) managed to adjust the RE and/or TE, but it was difficult to sustain it over time. With respect to materials, reagents, calibrators, and controls, they are produced by the industry depending on the state of their control. The homogeneity of the equipment depends on economic accessibility and volume of work. The environment, temperature, and water quality are a barrier to scalability.
Resumo Os programas de padronização da creatinina permanecem válidos. O objetivo é descrever a experiência adquirida durante o desenvolvimento de um programa de padronização de creatinina em uma província com poucos recursos e mostrar os aspectos que devem ser levados em consideração para sua escalabilidade em um contexto semelhante. O programa foi desenvolvido em etapas: Na primeira (2010), foi realizado um levantamento de 49 laboratórios clínicos (LC) distribuídos em toda a provincia do Chaco, na Argentina. Na segunda etapa (2012) o erro aleatório (EA) foi ajustado através da aplicação de protocolos internacionais (CLSI EP-5A). Na terceira etapa (2014-2015), foram processados paineis de soros com concentrações atribuídas por método rastreável à referência e ao padrão internacional (CG-IDMS). Protocolos internacionais foram aplicados para avaliar o erro total (ET) da determinação em cada laboratório (CLSI EP-10A). Em 2016, aplicando ferramentas de qualidade, foram avaliadas as barreiras no processo. Observou-se na EA: para o nível de 1,00 mg/dL nenhuma LC atingiu os níveis desejáveis; para um nível de 2,5 mg/dL, apenas 9 (23%) os atingiram. Concluídas a segunda e terceira etapas, apenas 18 laboratórios (48,7%) conseguiram ajustar o EA e/ou o ET, mas foi difícil sustentá-lo ao longo do tempo. No que diz respeito aos reagentes, calibradores e controles, eles são produzidos pela indústria. dependendo do estado o seu controle. A homogeneidade do equipamento depende da acessibilidade econômica e do volume de trabalho. O meio ambiente, a temperatura e a qualidade da água continuam sendo uma dificuldade para a escalabilidade.
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@#The expansion of healthcare services to serve as many people as possible has led to the decentralisation of laboratory testing. Many laboratory tests are now made available at district hospitals and rural health clinics for certain states or provinces. Consequently, there is a proliferation of laboratory tests, techniques, equipment, and other required commodities at the different medical laboratories. The lack of central governance has resulted in a widely-diverse and non-standardised laboratory services that may eventually affect the quality of healthcare delivery to patients. To ensure a high-quality and standardised healthcare delivery across a state or a province, it is important that the relevant stakeholders outline and implement the necessary strategies to establish a streamlined medical laboratory network. In this article, we discuss the significance of laboratory procurement consolidation and centralisation in the steering of the standardisation of laboratory operations leading to a high-quality and efficient chemical pathology services in a defined region.
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Pharmacognostic and phytochemical evaluation are necessary for drug authentication and for prediction and confirmation of pharmacological activities of any plant part. Cosmostigma racemosum (Roxb.) Wight, a traditional and folklore drug in Kerala with many reputed usages, locally called as Vaattuvalli, is a shrubby twiner of Apocynaceae family. Leaves are the most used plant part. As no scientific data regarding its standards were available, preliminary pharmacognostic, physico-chemical and phytochemical evaluation of the leaves were done as per the guidelines of Ayurveda Pharmacopoiea of India and WHO. The study revealed that leaves of Cosmostigma racemosum (Roxb.)Wight are simple, opposite, exstipulate, apex caudate, base cordate and with a characteristic chilly odour. Microscopic examination of leaves revealed the presence of characteristic features such as lacticifers, secreting cells, absence of stomata on the upper epidermis, presence of paracytic stomata on the lower epidermis and presence of calcium oxalate crystals especially druse crystals. The preliminary phytochemical evaluation revealed the presence of tannins, alkaloids, steroids, saponins which indicates the wide range of pharmacological activities of the plant. The 13 peaks in the HPTLC profile indicate a wide pharmacological prospect of the leaves. The ICP-MS analysis confirmed that heavy metals like Cd, Cr, Zn, Cu, Pb and As present in the leaves are within permissible limits. Physicochemical parameters such as moisture content, different ash values, volatile oil content, different extractive values, ph, fibre content, and sugar content were also determined. All these findings can serve as standards for assuring the safety, quality and purity of the drug.
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Taila Kalpana- A liquid dosage form of Ayurveda used for both external and internal application, has an important role in clinical practice. Asanavilwadi taila is a preparation mentioned in Sahasrayogam taila prakaranam and in Chikitsa manjari Siro roga chikitsa. It is used in the treatment of diseases of eye, ear and head and found to be very effective. Based on the data collected about the production of Asanavilwadi tailam from various manufacturing companies, it was noted that large amount of Asanavilwadi tila tailam and Asanavilwadi kera tailam are produced. In the present scenario there is increase in the number of manufacturing companies, increased production of formulations and there is decreased availability of raw drugs. So, it is necessary to confirm the genuinity of formulations available in the market. But Asanavilwadi tailam has not been standardized yet in API. This work was initiated to develop a standard analytical parameter for Asanavilwadi tila tailam and Asanavilwadi kera tailam. Asanavilwadi taila is prepared both in the media of Tila taila and Kera tailam as both samples are used for clinical practice and physico-chemical analyses were done. Standard analytical protocol proposed by Pharmacopoeial Laboratory of Indian Medicine (PLIM) and Ayurvedic Pharmacopoeia of India were taken as the study tool.
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Development of a reliable, cost-effective cytomegalovirus quantitative polymerase chain reaction (QPCR) is a priority for developing countries. Manufactured kits are expensive, and availability can be inconsistent. Development of an in-house QPCR kit that is reliable and quality assured requires significant effort and initial investment. However, the rewards of such an enterprise are manifold and include an in-depth understanding of molecular reactions, and expertise in the development of further low-cost molecular kits. The experience of an oncology centre in Eastern India has been shared. Hopefully, this would provide a brief roadmap for such an initiative. Staff with adequate understanding of molecular processes are essential along with vital infrastructure for molecular research and development.
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With the increasing demand for health care approaches, resurgence of herbal medicines has taken up great dimensions in changing the health care scenario across the globe. However, identification of the correct species of therapeutic importance is of utmost necessity to deliver quality products to the global market. Hence, modern approach in the standardization of single herbal preparations employing sophisticated techniques is the need of the hour. The evaluation of a product in its entirety, so-called “fingerprinting” can be accomplished by appropriate methods, which may include HPLC, GC-MS, HPTLC-densitometry, FT-NIR, high-field NMR or a combination of these techniques. Using chemical fingerprinting, plants can be demarcated on the basis of their species, strain and geographical origin. Chemical fingerprinting of plants, through chromatographic fingerprinting is highly informative which includes its use as an absolute indicator of the chemical characteristics of plants. Adulterants can be distinguished even in processed samples, enabling the authentication of the drug. Herein, in the present study two varieties of Ocimum species with green and purple coloured leaves collected from Tirunelvelli district commonly known as “Tulasi” in Tamil or “Holy Basil” in English and widely used in both ayurvedic and siddha drugs was subjected to chemical fingerprinting using HPTLC and GC. Moreover, the secondary metabolities such as polyphenols, tannins, and flavonoids were quantified to check the potency of the crude drug material. The bioactive molecule such as eugenol was found to be varying in both the species and the purple variety was found to contain more of the bioactive molecules. The fingerprinting of chemical profile as well as the quantification of the bioactive molecules in the two varieties of Ocimum species exemplified that fingerprinting using analytical techniques are comprehensive and more informative to identify and authenticate the raw drug and proves to be a tool for standardization of herbal drugs.