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Contribuição para o estudo do custo unitário das análises laboratoriais e sua comparação com a tabela de procedimentos da Associação Médica Brasileira - AMB 92, em um laboratório de pequeno porte / Contribution to the study of unitary cost of clinical analysis in comparison to the table of procedures of the Brazilian Medicai Association BMA 92, in a small size laboratoryFreitas, Gisele Palo Corrêa de 06 October 2005 (has links)
O Laboratório de Análises Clínicas (LAC) vem buscando, no decorrer dos anos, alternativas quanto à sua capacidade em gerar receita. A busca por melhores resultados incrementou a parceria com as organizações chamadas de \"convênios médicos\" ou \"medicina de grupo\" que, em geral, remuneram as análises laboratoriais com base em tabelas de procedimentos criadas pela Associação Médica Brasileira AMB. Destas, a mais utilizada é a Tabela AMB 92, devido a utilizar valores de Coeficiente de Honorários (CH), que convertidos em reais, são mais interessantes para os LAC. Este estudo teve como base o método recomendado pelo \"National Committee for Clinical Laboratory Standards\" - NCCLS, que normatiza a apuração do custo baseado na atividade desempenhada durante a sua realização. O objetivo deste trabalho foi estabelecer o custo das análises laboratoriais e verificar se, em comparação à tabela AMB 92, a opção pelos contratos com os \"convênios médicos\" realmente gera lucro a um laboratório de pequeno porte. Para tanto foram selecionadas as análises mais solicitadas no mês de agosto de 2004 em um laboratório de pequeno porte, que presta atendimento a pacientes conveniados a planos de saúde e particulares. O ressarcimento aos laboratórios prestadores de serviço é efetuado com base no valor do CH, que pode variar de acordo com o contrato firmado com os convênios médicos. Os resultados mostraram que na comparação dos custos unitários das 69 análises apuradas com a Tabela AMB-92 houve lucro em 52% das análises quando o valor de CH foi de R$ 0,2610 e quando atribuído um valor de CH de R$ 0,1800, houve lucro em apenas 28% das análises. / The Clinical Laboratory (CL) has been seeking, throughout these years, alternative forms of increasing budget. The search for better results has flourished partnerships with organizations named \"prepaid group practice\" or \"group medicine\" which usually reward the clinical analysis based on tables of procedures established by the Brazilian Medicai Association - BMA. Among them, the most employed is the BMA 92 Table, due to the use of payment coefficient values (PC) which, expressed in Brazilian currency (reais), are in CLs interests. This study was carried out based on the method recommended by the National Committee for Clinical Laboratory Standards - NCCLS, who draws up the regulation of the cost estimate of a procedure while it is carried out. The objective of this study was to establish the cost of clinical analysis and to verify if, comparing to the BMA 92 Table, the contracts with prepaid group practices are actually profitable for a small size laboratory. In order to achieve it, most requested analysis during August 2004 in a small size laboratory which offers services to patients affiliated with prepaid health plans and private health plans. The payment to the laboratories which offer services is made regarding the PC values, which may change according to the contract with the health plans. The results demonstrated that in comparison to the cost of each one of 69 analysis verified according to the BMA 92 Table, 52% of the analysis were profitable when the PC value was R$ 0.2610 and for the PC value of R$ 0.1800 only 28% of the analysis were profitable.
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Desenho e avaliação de um curso e-learning para a formação de enfermeiros em análises clínicasRenosto, Raquel de Araújo Carneiro 24 May 2015 (has links)
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Previous issue date: 2015-05-24 / Nenhuma / A enfermagem possui um papel de suma importância no contexto de Laboratórios de Análises Clínicas, principalmente na fase pré-analítica. O enfermeiro e sua equipe são os responsáveis pela execução dos procedimentos técnicos e os cuidados antes e depois da coleta de exames laboratoriais. Na diretriz curricular dos cursos de graduação em enfermagem, a exigência é de que o enfermeiro tenha uma formação generalista, humanista, crítica e reflexiva, se tornando um profissional qualificado para o exercício de Enfermagem com base no rigor científico e intelectual e pautado em princípios éticos. Para assegurar este perfil as instituições de ensino estruturam seus planos pedagógicos de forma genérica, dificultando a entrada de profissionais em campos específicos da enfermagem. Este fato se reflete na dificuldade de contratação de enfermeiros na área de análises clínicas. Por esta razão o objetivo deste estudo constitui-se do desenho e avaliação de um curso e-learning em análises clínicas para enfermeiros. É justamente para suprir esta lacuna, proporcionando ao profissional um conhecimento mais aprofundado neste segmento. A metodologia caracteriza-se por uma produção tecnológica, criando-se um produto/serviço dedicado à capacitação e especialização de enfermeiros na área de análises clínicas. O curso foi construído e executado com a utilização do Sistema de Gestão de Aprendizagem Moodle (Modular Object-Oriented Dynamic Learning Environment. O tema central do curso foi dividido em 10 módulos, perfazendo uma carga horária total de 60h, sendo eles todos sequenciais e complementares. O curso foi avaliado por onze juízes experts nas áreas de educação, análises clínicas e tecnologia da informação, embasados em três dimensões: pedagógica, tecnológica e comunicacional. De maneira geral, o curso foi avaliado pelos especialistas como suficiente, sendo que 16 dos 22 itens avaliados tiveram uma média acima do nível de concordância de 70%, os quais sugeriram oportunidades de melhoria. Conclui-se que este curso possibilitará o crescimento profissional de enfermeiros através de um processo de aprendizado dinâmico e colaborativo, proporcionando um saber fazer reflexivo com a utilização de diferentes ferramentas tecnológicas. / Nursing has an important role in Clinical Analyses Laboratories, especially in the pre- analytical phase. Nurses and their staff are responsible for implementing the technical procedures and they should take care of the laboratory exams before and after they are collected. In the curriculum of nursing graduation course, nurses must have a general, humane, critical and reflective requirement. They should become a qualified professional, for the practice of nursing based on scientific, intellectual and they should be guided by ethical principles. To ensure this nurse profile, the educational institutions structure their teaching on generic programs, hindering market entry by newcomers in specific fields of nursing. This fact demonstrates the difficulties found in the hiring of nurses in the area of clinical analyzes. For this reason, the aim of this study is to evaluate an "e-learning" nursing course in clinical analysis for nurses. This course is to fill the gap mentioned before and to provide the professionals, expertise in this field. The methodology is characterized by a technological production. It creates a product and/or service that dedicate itself to the training and expertise of professional nurses in clinical analysis. The course was built and run using the Moodle Learning Management System (Modular Object-Oriented Dynamic Learning Environment). The course has a workload of 60 hours, divided into 10 modules, and the modules are sequential and complementary. Twelve judges with expertise in education, clinical analysis and information technology evaluated the course. It was based on three pillars: pedagogical, technological and communication. The experts as satisfactory assessed the course, 16 out of 22 items were evaluated and had an average above the level of agreement of 70 %, which suggested improvement of opportunities for the nurses. We conclude that this specialization course will enable the growth of professional nurses through a dynamic and collaborative learning process, providing a reflective know -how, with the use of different technological tools.
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Gerenciamento de resíduos sólidos gerados em laboratório de análises clínicas na cidade de Ribeirão Preto - SP, 2007: um estudo de caso / Management of solid waste generated in laboratory analyses in the city of Ribeirão Preto - SP, 2007: a case studySilva, Claudia Mara da 28 March 2008 (has links)
O crescimento desordenado da população mundial, o aumento da industrialização, o consumismo exagerado, e, conseqüentemente, o aumento na geração de resíduos, vêm gerando impactos negativos na saúde humana e ambiental. No contexto dessa problemática ambiental, destaca-se a produção de resíduos perigosos e, entre esses, os resíduos de serviços de saúde - RSS. Por se caracterizarem como perigosos, várias recomendações, normas e legislações surgiram no âmbito mundial, no sentido de se encontrar um melhor sistema para seu manejo e destinação final. No Brasil, atualmente em vigor, as normas RDC No 306/04 da Anvisa e Resolução No 358/05 do Conama, dão diretrizes para a elaboração de um plano de gerenciamento de resíduos de serviços de saúde - PGRSS. Entretanto, tais legislações tratam os RSS de forma mais geral, não abordando especificamente a situação dos resíduos gerados em laboratórios de patologia e análises clínicas. O presente trabalho teve por objetivo diagnosticar a situação do gerenciamento de resíduos gerados em um laboratório de análises clínicas da rede privada, do município de Ribeirão Preto - SP, à luz da atual legislação brasileira sobre RSS. Trata-se de um estudo de caso com abordagem quali-quantitativa. A coleta de dados foi realizada por meio de duas entrevistas, uma observação sistematizada, e também pela caracterização dos resíduos gerados no serviço selecionado para o estudo. Pelas entrevistas e observação sistematizada foi possível constatar que o laboratório não possui um sistema de gerenciamento integralmente de acordo com as atuais legislações brasileiras, em especial no que se refere à elaboração do PGRSS, à determinação de um gerente de resíduos e à segregação, identificação e acondicionamento dos RSS. A caracterização dos 173,98 kg de resíduos totais gerados em 15 dias, de um período de quatro semanas, pelo laboratório revelou a produção dos cinco grupos de resíduos (A, B, C, D e E), segundo a legislação atual, sendo 92,88 kg de resíduos comuns (53,40%) e 81,10 kg (46,60 %) de resíduos segregados como RSS. A média diária de produção de resíduos comuns, de 15 dias das quatro semanas de estudo, foi de 6,19 kg/dia de resíduos comuns e de 5,41 kg/dia de RSS. Os tipos de resíduos mais freqüentemente encontrados foram: o plástico, que representou 31,22% da média diária segregada como RSS, seguido pelos perfurocortantes, que representaram 30,00% da média diária segregada como RSS. Os setores com maior produção de RSS foram os da Esterilização (35,43%), seguidos pelos setores de Coleta de Material (21,20%) e de Microbiologia (20,61%). Pelo estudo concluímos a necessidade de adaptação do laboratório pesquisado às atuais legislações, dando ênfase à imediata implantação de um PGRSS e de um Gerente de Resíduos, além de um programa de educação continuada em serviço. Ressaltamos, também, a importância do papel dos serviços de fiscalização sanitária e das agências ambientais, no sentido de contribuir para maior conscientização dos geradores de RSS, em especial dos serviços de saúde de pequeno porte, incluindose os laboratórios de análises clínicas. / World population has been growth disorderly; increasing industrialization; excessive consumerism, and, consequently, increasing the waste generation as well as the negative impacts on the environment and human health. In this context, the environmental problematic includes the production of hazardous waste and, among these, the waste of health services - RSS. Owing to it´s hazardous characterization, several recommendations, rules and laws came under world, to find a better system for its management and final destination. In Brazil, currently in force, the rules of RDC No 306/04 of Anvisa and of the Resolution No 358/05 of Conama, give guidelines for the preparation of a plan for managing waste of health services - PGRSS. However, such laws treat RSS more generally, not specifically addressing the situation of the waste generated in the laboratory of pathology and clinical analyses. This study aimed to diagnose the situation on the waste management generated in laboratory analyses of the private network, the municipality of Ribeirao Preto - SP, over the current brazilian legislation on RSS. This is a case study approach to qualiquantitative. Data collection was performed by means of two interviews, a systematic observation, and also for characterization of the waste generated in the service selected for the study. For interviews and systematic observation could see that the laboratory did not have a system of management entirely in accordance with the current brazilian legislation, in particular with regard to the preparation of PGRSS, the determination of a manager of waste and segregation, identification and packaging of RSS. The characterization of 173.98 kilograms of total waste generated in 15 days, a period of four weeks, the laboratory revealed the production of the five groups of waste (A, B, C, D and E), according to the current legislation, and 92.88 kg of waste common (53.40%) and 81.10 kilograms (46.60%) of waste segregated as RSS. The average daily production of waste common, 15 days of the four weeks of study, was 6.19 kg / day of waste common and 5.41 kg / day of RSS. The types of waste most frequently found were: the plastic, which accounted for 31.22% of the average daily segregated as RSS, followed by needlesticks, which accounted for 30.0% of the average daily segregated as RSS. The sectors with greater production of RSS were those of Sterilization (35.43%), followed by sectors of Collection of Material (21.20%) and Microbiology (20.61%). For the study concluded the need to adjust the laboratory researching the current laws, emphasizing the immediate deployment of a PGRSS and a Waste Manager, in addition to a program of continuing education in service. In conclusion, we also emphasize the importance of the role of services to animal health and environmental agencies, to help create greater awareness of the RSS, in particular the health services of small, including the clinical laboratory analyses.
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Gerenciamento de resíduos sólidos gerados em laboratório de análises clínicas na cidade de Ribeirão Preto - SP, 2007: um estudo de caso / Management of solid waste generated in laboratory analyses in the city of Ribeirão Preto - SP, 2007: a case studyClaudia Mara da Silva 28 March 2008 (has links)
O crescimento desordenado da população mundial, o aumento da industrialização, o consumismo exagerado, e, conseqüentemente, o aumento na geração de resíduos, vêm gerando impactos negativos na saúde humana e ambiental. No contexto dessa problemática ambiental, destaca-se a produção de resíduos perigosos e, entre esses, os resíduos de serviços de saúde - RSS. Por se caracterizarem como perigosos, várias recomendações, normas e legislações surgiram no âmbito mundial, no sentido de se encontrar um melhor sistema para seu manejo e destinação final. No Brasil, atualmente em vigor, as normas RDC No 306/04 da Anvisa e Resolução No 358/05 do Conama, dão diretrizes para a elaboração de um plano de gerenciamento de resíduos de serviços de saúde - PGRSS. Entretanto, tais legislações tratam os RSS de forma mais geral, não abordando especificamente a situação dos resíduos gerados em laboratórios de patologia e análises clínicas. O presente trabalho teve por objetivo diagnosticar a situação do gerenciamento de resíduos gerados em um laboratório de análises clínicas da rede privada, do município de Ribeirão Preto - SP, à luz da atual legislação brasileira sobre RSS. Trata-se de um estudo de caso com abordagem quali-quantitativa. A coleta de dados foi realizada por meio de duas entrevistas, uma observação sistematizada, e também pela caracterização dos resíduos gerados no serviço selecionado para o estudo. Pelas entrevistas e observação sistematizada foi possível constatar que o laboratório não possui um sistema de gerenciamento integralmente de acordo com as atuais legislações brasileiras, em especial no que se refere à elaboração do PGRSS, à determinação de um gerente de resíduos e à segregação, identificação e acondicionamento dos RSS. A caracterização dos 173,98 kg de resíduos totais gerados em 15 dias, de um período de quatro semanas, pelo laboratório revelou a produção dos cinco grupos de resíduos (A, B, C, D e E), segundo a legislação atual, sendo 92,88 kg de resíduos comuns (53,40%) e 81,10 kg (46,60 %) de resíduos segregados como RSS. A média diária de produção de resíduos comuns, de 15 dias das quatro semanas de estudo, foi de 6,19 kg/dia de resíduos comuns e de 5,41 kg/dia de RSS. Os tipos de resíduos mais freqüentemente encontrados foram: o plástico, que representou 31,22% da média diária segregada como RSS, seguido pelos perfurocortantes, que representaram 30,00% da média diária segregada como RSS. Os setores com maior produção de RSS foram os da Esterilização (35,43%), seguidos pelos setores de Coleta de Material (21,20%) e de Microbiologia (20,61%). Pelo estudo concluímos a necessidade de adaptação do laboratório pesquisado às atuais legislações, dando ênfase à imediata implantação de um PGRSS e de um Gerente de Resíduos, além de um programa de educação continuada em serviço. Ressaltamos, também, a importância do papel dos serviços de fiscalização sanitária e das agências ambientais, no sentido de contribuir para maior conscientização dos geradores de RSS, em especial dos serviços de saúde de pequeno porte, incluindose os laboratórios de análises clínicas. / World population has been growth disorderly; increasing industrialization; excessive consumerism, and, consequently, increasing the waste generation as well as the negative impacts on the environment and human health. In this context, the environmental problematic includes the production of hazardous waste and, among these, the waste of health services - RSS. Owing to it´s hazardous characterization, several recommendations, rules and laws came under world, to find a better system for its management and final destination. In Brazil, currently in force, the rules of RDC No 306/04 of Anvisa and of the Resolution No 358/05 of Conama, give guidelines for the preparation of a plan for managing waste of health services - PGRSS. However, such laws treat RSS more generally, not specifically addressing the situation of the waste generated in the laboratory of pathology and clinical analyses. This study aimed to diagnose the situation on the waste management generated in laboratory analyses of the private network, the municipality of Ribeirao Preto - SP, over the current brazilian legislation on RSS. This is a case study approach to qualiquantitative. Data collection was performed by means of two interviews, a systematic observation, and also for characterization of the waste generated in the service selected for the study. For interviews and systematic observation could see that the laboratory did not have a system of management entirely in accordance with the current brazilian legislation, in particular with regard to the preparation of PGRSS, the determination of a manager of waste and segregation, identification and packaging of RSS. The characterization of 173.98 kilograms of total waste generated in 15 days, a period of four weeks, the laboratory revealed the production of the five groups of waste (A, B, C, D and E), according to the current legislation, and 92.88 kg of waste common (53.40%) and 81.10 kilograms (46.60%) of waste segregated as RSS. The average daily production of waste common, 15 days of the four weeks of study, was 6.19 kg / day of waste common and 5.41 kg / day of RSS. The types of waste most frequently found were: the plastic, which accounted for 31.22% of the average daily segregated as RSS, followed by needlesticks, which accounted for 30.0% of the average daily segregated as RSS. The sectors with greater production of RSS were those of Sterilization (35.43%), followed by sectors of Collection of Material (21.20%) and Microbiology (20.61%). For the study concluded the need to adjust the laboratory researching the current laws, emphasizing the immediate deployment of a PGRSS and a Waste Manager, in addition to a program of continuing education in service. In conclusion, we also emphasize the importance of the role of services to animal health and environmental agencies, to help create greater awareness of the RSS, in particular the health services of small, including the clinical laboratory analyses.
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Contribuição para o estudo do custo unitário das análises laboratoriais e sua comparação com a tabela de procedimentos da Associação Médica Brasileira - AMB 92, em um laboratório de pequeno porte / Contribution to the study of unitary cost of clinical analysis in comparison to the table of procedures of the Brazilian Medicai Association BMA 92, in a small size laboratoryGisele Palo Corrêa de Freitas 06 October 2005 (has links)
O Laboratório de Análises Clínicas (LAC) vem buscando, no decorrer dos anos, alternativas quanto à sua capacidade em gerar receita. A busca por melhores resultados incrementou a parceria com as organizações chamadas de \"convênios médicos\" ou \"medicina de grupo\" que, em geral, remuneram as análises laboratoriais com base em tabelas de procedimentos criadas pela Associação Médica Brasileira AMB. Destas, a mais utilizada é a Tabela AMB 92, devido a utilizar valores de Coeficiente de Honorários (CH), que convertidos em reais, são mais interessantes para os LAC. Este estudo teve como base o método recomendado pelo \"National Committee for Clinical Laboratory Standards\" - NCCLS, que normatiza a apuração do custo baseado na atividade desempenhada durante a sua realização. O objetivo deste trabalho foi estabelecer o custo das análises laboratoriais e verificar se, em comparação à tabela AMB 92, a opção pelos contratos com os \"convênios médicos\" realmente gera lucro a um laboratório de pequeno porte. Para tanto foram selecionadas as análises mais solicitadas no mês de agosto de 2004 em um laboratório de pequeno porte, que presta atendimento a pacientes conveniados a planos de saúde e particulares. O ressarcimento aos laboratórios prestadores de serviço é efetuado com base no valor do CH, que pode variar de acordo com o contrato firmado com os convênios médicos. Os resultados mostraram que na comparação dos custos unitários das 69 análises apuradas com a Tabela AMB-92 houve lucro em 52% das análises quando o valor de CH foi de R$ 0,2610 e quando atribuído um valor de CH de R$ 0,1800, houve lucro em apenas 28% das análises. / The Clinical Laboratory (CL) has been seeking, throughout these years, alternative forms of increasing budget. The search for better results has flourished partnerships with organizations named \"prepaid group practice\" or \"group medicine\" which usually reward the clinical analysis based on tables of procedures established by the Brazilian Medicai Association - BMA. Among them, the most employed is the BMA 92 Table, due to the use of payment coefficient values (PC) which, expressed in Brazilian currency (reais), are in CLs interests. This study was carried out based on the method recommended by the National Committee for Clinical Laboratory Standards - NCCLS, who draws up the regulation of the cost estimate of a procedure while it is carried out. The objective of this study was to establish the cost of clinical analysis and to verify if, comparing to the BMA 92 Table, the contracts with prepaid group practices are actually profitable for a small size laboratory. In order to achieve it, most requested analysis during August 2004 in a small size laboratory which offers services to patients affiliated with prepaid health plans and private health plans. The payment to the laboratories which offer services is made regarding the PC values, which may change according to the contract with the health plans. The results demonstrated that in comparison to the cost of each one of 69 analysis verified according to the BMA 92 Table, 52% of the analysis were profitable when the PC value was R$ 0.2610 and for the PC value of R$ 0.1800 only 28% of the analysis were profitable.
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Understanding typhoid disease : a controlled human infection model of typhoid feverWaddington, Claire Shelley January 2014 (has links)
Typhoid disease, caused by infection with S. Typhi, is a significant cause of mortality and morbidity in resource–poor countries. Efforts have been made to generate a new generation of vaccines that are efficacious and can be given to infants, but have been hindered by a poor understanding of the protective immune response to S. Typhi infection, and in particular by the absence of a correlate of protection. Controlled human infection studies (‘challenge studies’) provide a model for investigating infectious diseases and appraising novel vaccines, including in typhoid disease. This DPhil described the development of a human challenge model of typhoid fever using <en>S. Typhi Quailes strain administered to healthy adults in a sodium bicarbonate buffer. The careful characterisation and manufactured of the strain is described. Following ingestion of 10<sup>3</sup> CFU of S. Typhi 55% of participants developed typhoid disease, whilst ingestion of 10<sup>4</sup> CFU gave a higher attack rate of 65%. At this attack rate vaccine efficacy against human challenge should be demonstrable with a modest sample size. Validity of the model in the appraisal of vaccines was demonstrated using Ty21a, a live, oral, attenuated vaccine. Protective efficacy of Ty21a compared to placebo against challenge was 35%, comparable to that observed in some endemic settings, and the estimated protection in the first year after vaccination in Cochrane meta-analysis. Clinical, microbiological and humoral immune responses were investigated in participants challenged during model development. Typhoid disease was associated with a high fever in most, but not all participants, and a range of symptoms. Severity of disease was variable, and included asymptomatic bacteraemia, as well as fever and symptoms in participants in whom bacteraemia could not be demonstrated. Typhoid disease was associated with a strong humoral immune response to the flagellin and lipopolysaccharide antigens of S. Typhi but not the Vi polysaccharide capsule. Humoral immune responses were not demonstrated in participants without typhoid fever. There was a dose-response relationship to the clinical, microbiological and humoral responses with participants challenged with 10<sup>4</sup> CFU having more marked responses than those challenged with 10<sup>3</sup> CFU. Future success of challenge studies relies on the willing participation of healthy adult volunteers. The motivations for participation, and experiences of participants, were appraised by questionnaire. Whilst financial compensation was an important motivator, it was not the sole motivator. Participants were positive about their experiences, and most would participate again.
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Metodverifiering av reagens med förhöjt tröskelvärde för biotininterferens för biomarkörerna NT-proBNP, prokalcitonin och prostataspecifikt antigen på Roche Cobas® e801.Hoberg, Emilia January 2020 (has links)
Biotin är ett vitamin som finns naturligt i livsmedel och det dagliga intaget nås via födan. Höga doser biotintillskott samt höga doser biotin i läkemedel, kan leda till biotininterferens i kliniska immunokemiska analyser. Roche Diagnostics® vill införa nya reagens med högre tröskel för biotininterferens för att minska risken för biotininterferens vid analys av patientplasma. Därför var syftet med studien att metodverifiera fyra nya reagens från Roche Diagnostics® som används vid diagnostisering och behandling av hjärtsvikt, sepsis, och prostatacancer. De fyra reagensen, Elecsys® proBNP II, Elecsys® BRAHMS PCT, Elecsys® total PSA samt Elecsys® free PSA metodverifierades för att användas på Cobas® e801. Studiematerialet bestod av 20 patientprover av litiumheparinplasma per reagens (totalt 80 patientprover). Resultatet av verifieringen av Elecsys® proBNP II visade en korrelation till det befintliga reagenset på r = 0,9998 och Bland-Altman analys visade en spridning av resultaten på < 10 %; inomserieprecisionsstudien gav CV 1,56 %. Elecsys® BRAHMS PCT hade en korrelation på r = 0,9997 och Bland-Altman analysen visade en spridning på > 10 %; inomserieprecisionsstudien gav CV 1,70 %. För Elecsys® total PSA och free PSA fanns korrelationen till det befintliga reagenset på r = 1 respektive 0,9997 och Bland- Altman analysen visade en spridning på < 10 % hos båda reagensen. Inomserieprecisionsstudien gav CV 0,44 % respektive CV 2,67 %. Resultaten för samtliga reagens uppvisar god korrelation till det befintliga reagenset och en hög mätnoggrannhet vilket talar för att de fyra nya reagensen kan tas i bruk. / Biotin is naturally found in foods, and we obtain this vitamin through our daily diet. Biotin supplements as well as high doses of biotin in drugs can lead to biotin interference in clinical immunochemical analyzes. Therefore, the purpose of this study was to methodically verify four new reagents from Roche Diagnostics® with a higher threshold for biotin interference, used in the diagnosis and treatment of heart faliure, sepsis and prostate cancer. The four reagents, Elecsys® proBNP II, Elecsys® BRAHMS PCT, Elecsys® total PSA and Elecsys® free PSA were method-verified for use on Cobas® e801. The study material consisted of 20 patient samples of lithium heparin plasma per reagent. In total 80 samples were analyzed.The result of the verification of Elecsys® proBNP II showed a correlation to the existing reagent of r = 0.9998 and Bland-Altman analysis showed a distribution of the results of <10 %. The withinseries precision study yielded CV 1.56 %. Elecsys® BRAHMS PCT had a correlation of r = 0.9997 and the Bland-Altman analysis showed a distribution of > 10 %. The withinseries precision study gave CV 1.70 %. For Elecsys® total PSA and free PSA, the correlation to the existing reagent was r = 1 and 0.9997, respectively, and the Bland-Altman analysis showed a distribution of <10 % in both reagents. The withinseries precision study yielded CV 0.44 % and CV 2.67 % respectively.The results for all reagents show a good correlation to the existing reagent and a high accuracy of measurement, which indicates that the four new reagents can be used.
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Verifiering av metod för analys av etylenglykol i plasma på Roche Cobas® c502Lindgren, Rebecca January 2021 (has links)
Etylenglykol (etan-1,2-diol) är en dihydroxyalkohol som är en komponent i kylarvätska och andra frost- och kylskyddsmedel. Förtäring av etylenglykol leder till allvarliga skador och i värsta fall död utan behandling. I Sverige år 2020 fanns det endast ett tiotal laboratorier som erbjöd analys av etylenglykol dygnet runt. Detta leder till att prover ofta behöver skickas till större laboratorier med taxi vilket i sin tur leder till en försenad diagnosticering av patienten. Syftet med examensarbetet var att verifiera en enzymatisk kolorimetrisk metod för analys av etylenglykol i plasma på instrumentet Roche Cobas® 8000 modul c502. Reagenset som verifierades var DiscretPak™ Ethylene Glycol Reagents från företaget Catachem. Verifieringen gjordes med avseende på total precision (repeterbarhet), inomserieprecision och linjäritet. Resultaten jämfördes med analys på gaskromatograf. Provmaterialet bestod av patientprover av litiumheparinplasma, patientprover av serum och kontrollprover från Equalis. Resultatet som erhölls vid verifieringen visade på linjär korrelation mellan den enzymatiska metoden och GC-analys. En negativ bias observerades dock i jämförelse med analys på gaskromatograf. Utvärdering av repeterbarhet gav CV 4,6% vid 9,0 mmol/L och 3,66% vid 40,0 mmol/L. Inomserieprecisionstudie gav CV 14,7% vid 1 mmol/L, 5,2% vid 4 mmol/L och 1,4% vid 17 mmol/L. Precisionen är viktigast vid de lägre koncentrationerna. Insättning av behandling med antidot är aktuellt vid 4 mmol/L. Utvärdering av linjäritet visade på ett starkt linjärt samband hos analysen vid koncentrationer <50 mmol/L. Vid koncentrationer >50 mmol/L fanns ett linjärt samband men en minskad överensstämmelse mellan den beräknade och den uppmätta koncentrationen observerades. Metodverifieringen ansågs vara godkänd för kliniskt bruk och analysen kommer att införas i analyssortimentet hos Klinisk Kemi i Växjö. / Ethylene glycol is an alcohol that is a common component in antifreeze. Ingestion of ethylene glycol will, without treatment, lead to severe organ damage and in worst-case death. In 2020 there was only a few laboratories in Sweden that offered analysis of ethylene glycol all hours of the day and week. This means that samples often need to be transported to laboratories at larger hospitals which leads delayed diagnosis of the patient. The purpose of this study was to verify an enzymatic method for analysis of ethylene glycol in plasma on the instrument Roche Cobas® 8000 module c502. The reagent that was used was DiscretPak™ Ethylene Glycol Reagents from Catachem. The study included evaluation of total precision, within-run precision, linearity, and a comparison with analysis with gas chromatography (GC). The sample material consisted of patient samples of plasma, patient samples of serum and quality controls from Equalis. The result of the study showed linear correlation between the enzymatic method and analysis with GC. A negative bias was observed in comparison to analysis with GC. The coefficient of variation (CV) for total precision was 4,7% at 9,0 mmol/L and 3,7% at 40,0 mmol/L. The CV for within-run was 14,7% at 1 mmol/L, 5,2% at 4 mmol/L and 1,4% at 17 mmol/L. The precision of the method is most important at lower concentrations. The evaluation of linearity showed linear correlation at concentrations <50 mmol/L with. A linear correlation was observed at concentrations >50 mmol/L, although the agreement with the calculated concentrations decreased. The method verification was successful as the results were deemed acceptable for clinical use.
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Utveckling av metoder för att analysera ”C5 Nephritic Factors” (C5NeF) / Development of methods for analysis of ”C5 Nephritic Factors” (C5NeF)Bäckström, Filippa January 2021 (has links)
Normalt sett skyddar komplementsystemet kroppen mot infektioner och patogener. Vid vissa typer av njursjukdomar, framför allt vid C3-glomerulopati, förekommer autoantikroppar som kallas ”nephritic factors” (NeF). Sådana antikroppar stabiliserar enzymkomplex (konvertas) i komplementsystemet, vilket leder till destruktiv komplementaktivering via den alternativa vägen. Syftet med studien var att utveckla minst en metod för att analysera C5NeF på kliniska prover. C5NeF In-House ELISA analyserade bindning av C5NeF till C5-konvertas. Analys av C5-klyvning i löslig fas kvantifierade mängden C5a som bildats vid stabilisering av C5-konvertas. Cut-off för analyserna bestämdes genom analys av prover från 20 friska blodgivare. Tolv patientprover med möjlig förekomst av C5NeF analyserades. För att utesluta falskt positiv reaktion i C5NeF in-house ELISA analyserades även förekomst av antikroppar mot specifika enskilda komplementproteiner. Åtta patientprover var positiva i C5NeF In-House ELISA, fem patientprover uppvisade positivt resultat för C3NeF, vilket inte var oväntat utifrån tidigare publikationer som visat att det är vanligt att patienter med C5NeF också ofta är positiva för C3NeF. Tre patientprover erhöll positivt resultat i endast C5NeF In-House ELISA och två av dessa var positiva i analys av C5-klyvning i löslig fas. Studien resulterade i etablering av en metod för analys av C5NeF. / Normally the complement system protects the body from infections and pathogens. In certain types of kidney diseases, mainly C3-glomerulopathy, autoantibodies called ”Nephritic Factors” (NeF) are found. NeFs stabilize enzyme complexes (convertases) in the complement system, an event which leads to destructive complement activation via the alternative pathway. The purpose of this study was to develop at least one method to analyse C5NeF on clinical samples. C5NeF In-House ELISA analysed binding of C5NeF to C5 convertases. Analysis of C5-cleavage in the soluble phase measured the amount of C5a formed when C5-convertase was stabilized. Cut-off for the analyses was determined through analysis of 20 blood donor samples from healthy individuals. Twelve patient samples with possible C5NeF were analysed. To exclude false positive results in C5NeF In-House ELISA analysis of antibodies against specific single complement factors was performed. Eight patient samples were positive in C5NeF In-House ELISA, five patient samples showed positive result for C3NeF, a finding which was not unexpected as previous publications have shown that concomitant presence of C3NeF and C5NeF is common in C3-glomerulopathy. Where most patients are positive for both C3NeF and C5NeF. Three patient samples received positive result in only C5NeF In-House ELISA and two of these samples were positive in the analysis of C5-cleavage in soluble phase. In conclusion, in this study a method to examine C5NeF was developed.
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Description, Classification, and Prediction of Dengue Illnesses in a Thai Pediatric Cohort: A DissertationPotts, James A. 12 May 2010 (has links)
Dengue fever (DF) and dengue hemorrhagic fever (DHF) are emerging infectious diseases which are endemic in many regions of the globe, many of which are resource-poor areas. DHF and DF impose a severe economic health burden in tropical and subtropical areas. Dengue virus causes an acute febrile illness that can be a self-limited febrile illness, as seen in most cases of DF, or a life-threatening illness with plasma leakage and shock, as seen in cases of DHF. A systematic review of the literature revealed gaps in the knowledge base of clinical laboratory findings of dengue illness with regards to longitudinal dynamics and classification and predictive modeling of disease severity. The objective of this thesis was to investigate the utility of clinical laboratory variables for classification and prediction of disease outcomes.
The data used in this investigation was derived from a prospective study of Thai children presenting to either of two study hospitals within 72 hours of onset of an acute febrile illness. Systematic data collection, including clinical laboratory parameters, and routine clinical management continued each day until 24 hours after the fever had subsided. A final diagnosis of DHF, DF, or other febrile illness (OFI) was assigned by an expert physician after chart review.
The first research objective of this study was to describe the temporal dynamics of clinical laboratory parameters among subjects with DHF, DF, or OFI. Data were analyzed using lowess curves and population-average models. Quadratic functions of clinical variables over time were established and demonstrated significantly divergent patterns between the various diagnostic groups.
The second research objective was to establish and validate tools for classification of illness severity using easily obtained clinical laboratory measures. Bivariate logistic regression models were established using data from one hospital in an urban area of Thailand as a training data set and validated with a second data set from a hospital in a rural area of Thailand. The validated models maintained a high sensitivity and specificity in distinguishing severe dengue illnesses without using the hallmark indicators of plasma leakage.
The third research objective used classification and regression tree (CART) analysis to established diagnostic decisions trees using data obtained on the day of study enrollment, within the first 3 days of acute illness. Decision trees with high sensitivity were established for severe dengue defined either as: 1) DHF with evidence of shock (dengue shock syndrome, DSS); or 2) DSS or dengue with significant pleural effusion.
This study expands existing knowledge of the potential utility of clinical laboratory variables during different phases of dengue illness. The application of the results of these studies should lead to promising opportunities in the fields of epidemiological research and disease surveillance to reduce the health burden, and improve the clinical management, of dengue illness. Future directions involve application of these algorithms to different study populations and age groups. Additionally, other analytical techniques, such as those involving CART analysis, can be explored with these data.
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