Standardization of method for determining glycosylated hemoglobin (Hb A1c) by cation exchange high performance liquid chromatography
Hemoblobin A1c is the most important parameter for the monitoring of metabolic control of patients with diabetes mellitus. The purpose of this study was to adapt the Mono S method to a conventional HPLC system, allowing highly selective HbA1c determination without the acquisition of kits or the use...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Universidade de São Paulo
2009-12-01
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| Series: | Brazilian Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502009000400007 |
| _version_ | 1819024298192404480 |
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| author | Marina Venzon Antunes Sandrine Comparsi Wagner Joíza Lins Camargo Rafael Linden |
| author_facet | Marina Venzon Antunes Sandrine Comparsi Wagner Joíza Lins Camargo Rafael Linden |
| author_sort | Marina Venzon Antunes |
| collection | DOAJ |
| description | Hemoblobin A1c is the most important parameter for the monitoring of metabolic control of patients with diabetes mellitus. The purpose of this study was to adapt the Mono S method to a conventional HPLC system, allowing highly selective HbA1c determination without the acquisition of kits or the use of dedicated systems The results obtained were compared to the Tinaquant® immune turbidimetric method and the Bio-Rad Variant® chromatographic method. The developed method presented intra-study precision (C.V. %) of 1.39-3.65 and inter-study precision (C.V. %) of 2.80-3.02%. The determination coefficients among methods were: HPLC Mono S x Tinaquant®: r²: 0.9856 (n=60) and HPLC Mono S x HPLC Bio-Rad Variant®: r²: 0.9806 (n=16). A conversion equation between HPLC Mono S and Bio-Rad Variant® was calculated allowing yielding comparable and interchangeable values. The HPLC Mono-S is a precise, low-cost method which yields similar values to the Bio-Rad Variant® method on conventional HPLC equipment.<br>A hemoglobina A1c é o parâmetro laboratorial mais importante no monitoramento do controle metabólico de pacientes portadores de diabetes melito. Dentre as metodologias existentes para a quantificação desta fração de hemoglobina, a cromatografia líquida de alta eficiência (CLAE) baseada em troca catiônica apresenta a melhor precisão, sendo o método de escolha. O objetivo deste trabalho foi adaptar o método Mono S a um sistema de CLAE convencional permitindo a disponibilidade da determinação altamente seletiva de Hb A1c sem a aquisição de kits e comparar os resultados obtidos com o método imunoturbidimétrico Tinaquant® (Roche®) e com o método de cromatografia líquida Bio-Rad Variant®. O método desenvolvido apresentou precisão intra-ensaio de 1,39-3,65% e inter-ensaio de 2,80-3,02%. Os coeficientes de determinação entre os métodos foram: CLAE Mono S x Tinaquant®: r² = 0,9856 (n=60) e CLAE Mono S x Bio-Rad Variant®: r² = 0,9806 (n=16). Não foram observadas diferenças entre CLAE Mono S e Bio-Rad Variant® através de gráfico de Bland-Altman e regressão de Passing-Bablok. Foi obtida uma equação de conversão entre os valores do método teste e os valores obtidos por métodos rastreáveis ao National Glycohemoglobin Standardization Program (NGSP), permitindo a obtenção de valores comparáveis e intercambiáveis entre as metodologias com o uso de instrumentos convencionais de CLAE e com custo reduzido. |
| first_indexed | 2024-12-21T04:52:34Z |
| format | Article |
| id | doaj.art-12b5cad09ef948d1912742dd86857efa |
| institution | Directory Open Access Journal |
| issn | 1984-8250 2175-9790 |
| language | English |
| last_indexed | 2024-12-21T04:52:34Z |
| publishDate | 2009-12-01 |
| publisher | Universidade de São Paulo |
| record_format | Article |
| series | Brazilian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-12b5cad09ef948d1912742dd86857efa2022-12-21T19:15:24ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences1984-82502175-97902009-12-0145465065710.1590/S1984-82502009000400007Standardization of method for determining glycosylated hemoglobin (Hb A1c) by cation exchange high performance liquid chromatographyMarina Venzon AntunesSandrine Comparsi WagnerJoíza Lins CamargoRafael LindenHemoblobin A1c is the most important parameter for the monitoring of metabolic control of patients with diabetes mellitus. The purpose of this study was to adapt the Mono S method to a conventional HPLC system, allowing highly selective HbA1c determination without the acquisition of kits or the use of dedicated systems The results obtained were compared to the Tinaquant® immune turbidimetric method and the Bio-Rad Variant® chromatographic method. The developed method presented intra-study precision (C.V. %) of 1.39-3.65 and inter-study precision (C.V. %) of 2.80-3.02%. The determination coefficients among methods were: HPLC Mono S x Tinaquant®: r²: 0.9856 (n=60) and HPLC Mono S x HPLC Bio-Rad Variant®: r²: 0.9806 (n=16). A conversion equation between HPLC Mono S and Bio-Rad Variant® was calculated allowing yielding comparable and interchangeable values. The HPLC Mono-S is a precise, low-cost method which yields similar values to the Bio-Rad Variant® method on conventional HPLC equipment.<br>A hemoglobina A1c é o parâmetro laboratorial mais importante no monitoramento do controle metabólico de pacientes portadores de diabetes melito. Dentre as metodologias existentes para a quantificação desta fração de hemoglobina, a cromatografia líquida de alta eficiência (CLAE) baseada em troca catiônica apresenta a melhor precisão, sendo o método de escolha. O objetivo deste trabalho foi adaptar o método Mono S a um sistema de CLAE convencional permitindo a disponibilidade da determinação altamente seletiva de Hb A1c sem a aquisição de kits e comparar os resultados obtidos com o método imunoturbidimétrico Tinaquant® (Roche®) e com o método de cromatografia líquida Bio-Rad Variant®. O método desenvolvido apresentou precisão intra-ensaio de 1,39-3,65% e inter-ensaio de 2,80-3,02%. Os coeficientes de determinação entre os métodos foram: CLAE Mono S x Tinaquant®: r² = 0,9856 (n=60) e CLAE Mono S x Bio-Rad Variant®: r² = 0,9806 (n=16). Não foram observadas diferenças entre CLAE Mono S e Bio-Rad Variant® através de gráfico de Bland-Altman e regressão de Passing-Bablok. Foi obtida uma equação de conversão entre os valores do método teste e os valores obtidos por métodos rastreáveis ao National Glycohemoglobin Standardization Program (NGSP), permitindo a obtenção de valores comparáveis e intercambiáveis entre as metodologias com o uso de instrumentos convencionais de CLAE e com custo reduzido.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502009000400007Cromatografia líquida de alta eficiênciaMono SHemoglobinaHemoglobinaHigh performance liquid chromatographyMono SHemoglobinHemoglobin |
| spellingShingle | Marina Venzon Antunes Sandrine Comparsi Wagner Joíza Lins Camargo Rafael Linden Standardization of method for determining glycosylated hemoglobin (Hb A1c) by cation exchange high performance liquid chromatography Brazilian Journal of Pharmaceutical Sciences Cromatografia líquida de alta eficiência Mono S Hemoglobina Hemoglobina High performance liquid chromatography Mono S Hemoglobin Hemoglobin |
| title | Standardization of method for determining glycosylated hemoglobin (Hb A1c) by cation exchange high performance liquid chromatography |
| title_full | Standardization of method for determining glycosylated hemoglobin (Hb A1c) by cation exchange high performance liquid chromatography |
| title_fullStr | Standardization of method for determining glycosylated hemoglobin (Hb A1c) by cation exchange high performance liquid chromatography |
| title_full_unstemmed | Standardization of method for determining glycosylated hemoglobin (Hb A1c) by cation exchange high performance liquid chromatography |
| title_short | Standardization of method for determining glycosylated hemoglobin (Hb A1c) by cation exchange high performance liquid chromatography |
| title_sort | standardization of method for determining glycosylated hemoglobin hb a1c by cation exchange high performance liquid chromatography |
| topic | Cromatografia líquida de alta eficiência Mono S Hemoglobina Hemoglobina High performance liquid chromatography Mono S Hemoglobin Hemoglobin |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502009000400007 |
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