Análise comparativa de métodos para a determinação da Hemoglobina Glicosilada
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2019-01-29
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A Diabetes mellitus (DM) é um distúrbio metabólico crónico que resulta numa hiperglicemia persistente. Esta anomalia origina distúrbios no metabolismo dos hidratos de carbono, lípidos e proteínas, resultantes de deficiências na secreção ou ação da insulina, ou de ambas. O número de casos de pessoas com diabetes tem vindo a aumentar em 90 a 95% dos países desenvolvidos. Para diagnosticar e controlar esta doença os níveis de glucose no sangue não são suficientes. A hemoglobina A1c (HbA1c) é um subgrupo das hemoglobinas glicada, que é irreversivelmente glicada, e a sua a percentagem no sangue é indicador dos valores de glucose nos últimos 2 a 3 meses, o que permite deste modo uma melhor monitorização. O aparecimento e desenvolvimento da tecnologia ligada a área clínica permitiu a criação de analisadores automáticos desta hemoglobina para o estudo da diabetes. Existe nos dias de hoje cerca de 20 métodos de ensaio, baseados em diferentes princípios analíticos, como a turbidimetria imunológica, a cromatografia de troca catiónica e a cromatografia líquida de alta eficiência (HPLC - High performance liquid chromatography ). O objetivo deste estudo é avaliar os resultados de dois analisadores automáticos de rotina laboratorial para a HbA1c, com o intuito de uma avaliação dos métodos para uso em laboratórios clínicos e tentar estabelecer uma relação entre os resultados de ambos. Os aparelhos usados foram o G7 HPLC Analyzer e o COBAS INTEGRA® 400 plus, que corresponde respetivamente aos métodos de cromatografia líquida de alta eficiência de imunoensaio de inibição turbidimétrica (TINIA). Para a realização deste estudo foram analisadas 118 amostras de sangue total, de utentes do Centro Hospitalar de Trás-os-Montes e Alto Douro, aos quais foi pedida a analises a HbA1c. As amostras foram analisadas em primeiro lugar pelo método de rotina do hospital, no G7 HPLC Analyzer e posteriormente no COBAS INTEGRA® 400 plus. O processo de amostragem e todo o manuseamento foi realizado de acordo com as instruções dos fabricantes para ambos os métodos. Apesar dos métodos serem certificado pelo NGSP a análise dos resultados permitiu concluir que o método de imunoensaio, apresenta resultados menos adequados quando comparado com o método de HPLC para a determinação medica de HbA1c.
Diabetes mellitus (DM) is a chronic metabolic disorder that results in persistent hyperglycemia. This anomaly causes disorders in the metabolism of carbohydrates, lipids and proteins, resulting from deficiencies in the secretion or action of insulin, or both. The number of cases of people with diabetes has been increasing in 90 to 95% of developed countries. Blood glucose levels are not enough to diagnose and control this disease. Hemoglobin A1c (HbA1c) is a subgroup of glycated hemoglobins, which are irreversibly glycated, and its percentage in blood is indicative of glucose values in the last 2 to 3 months, which allows for better monitoring. The appearance and development of technology linked to the clinical area allowed the creation of automatic analyzers of this hemoglobin for the study of diabetes. There are currently around 20 test methods based on different analytical principles such as immunological turbidimetry, cation exchange chromatography, and high performance liquid chromatography (HPLC). The objective of this study is to evaluate the results of two automated routine laboratory analyzers for HbA1c, with the purpose of evaluating the methods for use in clinical laboratories and trying to establish a relationship between the results of both. The devices used were the G7 HPLC Analyzer and the COBAS INTEGRA® 400 plus, which corresponds to the high efficiency liquid chromatography method and turbidimetric inhibition immunoassay (TINIA). For the accomplishment of this study, 118 samples of total blood of users of the Hospital Center of Trás-os-Montes and Alto Douro were analyzed, to which HbA1c analyzes were requested. Samples were first analyzed by the hospital routine method, in the G7 HPLC Analyzer and later in the COBAS INTEGRA® 400 plus. The sampling procedure and all handling were performed according to the manufacturers' instructions for both methods. Although the methods were certified by the NGSP, the analysis of the results allowed to conclude that the immunoassay method presents less suitable results when compared to the HPLC method for the medical determination of HbA1c.
Diabetes mellitus (DM) is a chronic metabolic disorder that results in persistent hyperglycemia. This anomaly causes disorders in the metabolism of carbohydrates, lipids and proteins, resulting from deficiencies in the secretion or action of insulin, or both. The number of cases of people with diabetes has been increasing in 90 to 95% of developed countries. Blood glucose levels are not enough to diagnose and control this disease. Hemoglobin A1c (HbA1c) is a subgroup of glycated hemoglobins, which are irreversibly glycated, and its percentage in blood is indicative of glucose values in the last 2 to 3 months, which allows for better monitoring. The appearance and development of technology linked to the clinical area allowed the creation of automatic analyzers of this hemoglobin for the study of diabetes. There are currently around 20 test methods based on different analytical principles such as immunological turbidimetry, cation exchange chromatography, and high performance liquid chromatography (HPLC). The objective of this study is to evaluate the results of two automated routine laboratory analyzers for HbA1c, with the purpose of evaluating the methods for use in clinical laboratories and trying to establish a relationship between the results of both. The devices used were the G7 HPLC Analyzer and the COBAS INTEGRA® 400 plus, which corresponds to the high efficiency liquid chromatography method and turbidimetric inhibition immunoassay (TINIA). For the accomplishment of this study, 118 samples of total blood of users of the Hospital Center of Trás-os-Montes and Alto Douro were analyzed, to which HbA1c analyzes were requested. Samples were first analyzed by the hospital routine method, in the G7 HPLC Analyzer and later in the COBAS INTEGRA® 400 plus. The sampling procedure and all handling were performed according to the manufacturers' instructions for both methods. Although the methods were certified by the NGSP, the analysis of the results allowed to conclude that the immunoassay method presents less suitable results when compared to the HPLC method for the medical determination of HbA1c.
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Dissertação de Mestrado em Biologia Clínica Laboratorial
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Diabetes mellitus , HbA1c , HPLC , imunoensaio , TINIA