Desempenho e estabilidade de parâmetros bioquímicos em materiais de controle líquidos congelados e sólidos liofilizados
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Data
2011-08-19
Autores
Nunes, Tânia Navarro [UNESP]
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Universidade Estadual Paulista (Unesp)
Resumo
O uso de amostras-controle para acompanhamento do desempenho analítico é necessário para reproduzir a veracidade dos resultados das análises, pois monitora as variações que podem ocorrer no sistema analítico. O ideal para amostras-controle é ter a mesma matriz que as amostras dos pacientes, assim elas comportar-se-ão da mesma forma. Entretanto, para alcançar a estabilidade necessária, as amostras-controle passam por manipulações durante sua produção que podem alterar as propriedades da matriz. Dentre estas manipulações estão a adição de aditivos e mudanças físicas do meio como o congelamento ou liofilização. Neste estudo, nós produzimos amostras-controle com pool de soro humano trabalhados na forma líquida, congelados, conservados a ≤ -18°C e ≤ -80°C e sólida a 2 - 8°C liofilizados, sem preservante e com preservante e analisamos 23 analitos da rotina de laboratório clínico: ácido úrico, albumina, fosfatase alcalina, alanina aminotransferase, amilase, aspartato aminotransferase, bilirrubina direta, bilirrubina total, cálcio, capacidade latente de ligação do ferro, colesterol, creatinina, ferro, fósforo, gama-glutamil transferase, glicose, colesterol- HDL, desidrogenase lática, potássio, proteínas totais, sódio, triglicérides e uréia. As amostras foram analisadas por 300 dias, e comparado a estabilidade entre os soros sem preservante e com preservante nos diferentes processos de conservação. Os coeficientes de variação encontrados foram bastante satisfatórios, mas a estabilidade no decorrer do tempo foi melhor observada no soro com preservante, especialmente a 2 - 8°C - liofilizado, onde todos os analitos estudados permaneceram estáveis por 300 dias, com exceção do ácido úrico que foi de 240 dias
Using control-samples for analytical performance monitoring is required to reproduce the veracity of the results of biochemical analyses, since them monitors changes that may occur in analytical system. The ideal for control-samples is to have the same matrix that samples of the patients, so they will behave the same way. However, to achieve the necessary stability control-samples undergo operations such as sum additives and/or physical changes of middle (freezing or lyophilization) during its production which can change the properties of the matrix. In this study, we produced control-samples with pool of human serum worked in frozen liquid form kept at ≤ -18°C and ≤ -80°C and freeze-dried solid kept between 2 – 8°C, without or with a preservative for 23 analytes of clinical laboratory routine: uric acid, serum albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, amylase, direct bilirubin, total bilirubin, calcium, latent iron-binding capacity, cholesterol, creatinine, iron, phosphorus, gamma glutamyl transferase, HDL-cholesterol, glucose, lactic dehydrogenase, total proteins, potassium, sodium, triglycerides and urea. The samples were analyzed for 300 days, and the stability compared between the without a preservative and with a preservative sera in different processes of conservation. The coefficient of variation found were quite satisfactory, but stability over time was better observed in with a preservative serum, mainly in serum stored between 2 – 8°C - freeze-dried, in which all analytes studied remained stable for 300 days, with the exception of uric acid that was for 240 days
Using control-samples for analytical performance monitoring is required to reproduce the veracity of the results of biochemical analyses, since them monitors changes that may occur in analytical system. The ideal for control-samples is to have the same matrix that samples of the patients, so they will behave the same way. However, to achieve the necessary stability control-samples undergo operations such as sum additives and/or physical changes of middle (freezing or lyophilization) during its production which can change the properties of the matrix. In this study, we produced control-samples with pool of human serum worked in frozen liquid form kept at ≤ -18°C and ≤ -80°C and freeze-dried solid kept between 2 – 8°C, without or with a preservative for 23 analytes of clinical laboratory routine: uric acid, serum albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, amylase, direct bilirubin, total bilirubin, calcium, latent iron-binding capacity, cholesterol, creatinine, iron, phosphorus, gamma glutamyl transferase, HDL-cholesterol, glucose, lactic dehydrogenase, total proteins, potassium, sodium, triglycerides and urea. The samples were analyzed for 300 days, and the stability compared between the without a preservative and with a preservative sera in different processes of conservation. The coefficient of variation found were quite satisfactory, but stability over time was better observed in with a preservative serum, mainly in serum stored between 2 – 8°C - freeze-dried, in which all analytes studied remained stable for 300 days, with the exception of uric acid that was for 240 days
Descrição
Palavras-chave
Laboratório clínico - Precisão, Materias de controle líquidos congelados, Controle de qualidade analítico, Clinical laboratory
Como citar
NUNES, Tânia Navarro. Desempenho e estabilidade de parâmetros bioquímicos em materiais de controle líquidos congelados e sólidos liofilizados. 2011. 173 f. Dissertação (mestrado) - Universidade Estadual Paulista, Faculdade de Ciências Farmacêuticas, 2011.