{"title":"微粒增强免疫比浊法 (PEIT) 与高效液相色谱法 (HPLC) 在糖化血红蛋白 (HbA1c) 分析中的方法比较。","authors":"Shabnam Dildar, Sheharbano Imran, Farah Naz","doi":"10.1186/s40842-021-00123-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objective: </strong>High Performance Liquid Chromatography (HPLC) technique is considered as a gold standard for HbA1c analysis however all laboratories cannot adopt it due to certain limitations. Our aim was to compare Particle Enhanced Immunoturbidimetry (PEIT) method with High Performance Liquid Chromatography (HPLC) for HbA1c analysis.</p><p><strong>Method: </strong>All blood samples were analyzed by HPLC assay on a Bio-Rad D-10 analyzer and PEIT on an Erba XL-200 analyzer. Precision studies were undertaken and Coefficient of Variation (%CV) calculated. Systemic Error (SE), Random Error (RE) and Total Error (TE<sub>calc</sub>) were obtained. The Total Allowable Error (TEa) set by the National Glycohemoglobin Standardization Program (NGSP) for HbA1c is 6%.The acceptable evaluation method is where TE<sub>calc</sub> is less than TE<sub>a.</sub> RESULTS: The Precision studies were satisfactory with Coefficient of Variation (%CV) being less than 4% for both techniques. Mean HbA1c levels were slightly higher from HPLC than PEIT 9.07 ± 2.23% and 8.93 ± 2.10% respectively, although the difference was minimal. RE was 1.41%, TE<sub>calc</sub> was 1.55%, which was less than TEa set by the NGSP. Both methods strongly correlated with the correlation coefficient (r) 0.9716, p < 0.0001.</p><p><strong>Conclusion: </strong>Our study showed HbA1c analysis by PEIT technique is precise, accurate, rapid and convenient and can be employed as an alternative to HPLC technique in countries where cost is a major problem for diagnosis and treatment.</p>","PeriodicalId":56339,"journal":{"name":"Clinical Diabetes and Endocrinology","volume":"7 1","pages":"10"},"PeriodicalIF":0.0000,"publicationDate":"2021-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8201666/pdf/","citationCount":"0","resultStr":"{\"title\":\"Method comparison of Particle Enhanced Immunoturbidimetry (PEIT) with High Performance Liquid Chromatography (HPLC) for glycated hemoglobin (HbA1c) analysis.\",\"authors\":\"Shabnam Dildar, Sheharbano Imran, Farah Naz\",\"doi\":\"10.1186/s40842-021-00123-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and objective: </strong>High Performance Liquid Chromatography (HPLC) technique is considered as a gold standard for HbA1c analysis however all laboratories cannot adopt it due to certain limitations. Our aim was to compare Particle Enhanced Immunoturbidimetry (PEIT) method with High Performance Liquid Chromatography (HPLC) for HbA1c analysis.</p><p><strong>Method: </strong>All blood samples were analyzed by HPLC assay on a Bio-Rad D-10 analyzer and PEIT on an Erba XL-200 analyzer. Precision studies were undertaken and Coefficient of Variation (%CV) calculated. Systemic Error (SE), Random Error (RE) and Total Error (TE<sub>calc</sub>) were obtained. The Total Allowable Error (TEa) set by the National Glycohemoglobin Standardization Program (NGSP) for HbA1c is 6%.The acceptable evaluation method is where TE<sub>calc</sub> is less than TE<sub>a.</sub> RESULTS: The Precision studies were satisfactory with Coefficient of Variation (%CV) being less than 4% for both techniques. Mean HbA1c levels were slightly higher from HPLC than PEIT 9.07 ± 2.23% and 8.93 ± 2.10% respectively, although the difference was minimal. RE was 1.41%, TE<sub>calc</sub> was 1.55%, which was less than TEa set by the NGSP. Both methods strongly correlated with the correlation coefficient (r) 0.9716, p < 0.0001.</p><p><strong>Conclusion: </strong>Our study showed HbA1c analysis by PEIT technique is precise, accurate, rapid and convenient and can be employed as an alternative to HPLC technique in countries where cost is a major problem for diagnosis and treatment.</p>\",\"PeriodicalId\":56339,\"journal\":{\"name\":\"Clinical Diabetes and Endocrinology\",\"volume\":\"7 1\",\"pages\":\"10\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-06-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8201666/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Diabetes and Endocrinology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s40842-021-00123-w\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Diabetes and Endocrinology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40842-021-00123-w","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Method comparison of Particle Enhanced Immunoturbidimetry (PEIT) with High Performance Liquid Chromatography (HPLC) for glycated hemoglobin (HbA1c) analysis.
Background and objective: High Performance Liquid Chromatography (HPLC) technique is considered as a gold standard for HbA1c analysis however all laboratories cannot adopt it due to certain limitations. Our aim was to compare Particle Enhanced Immunoturbidimetry (PEIT) method with High Performance Liquid Chromatography (HPLC) for HbA1c analysis.
Method: All blood samples were analyzed by HPLC assay on a Bio-Rad D-10 analyzer and PEIT on an Erba XL-200 analyzer. Precision studies were undertaken and Coefficient of Variation (%CV) calculated. Systemic Error (SE), Random Error (RE) and Total Error (TEcalc) were obtained. The Total Allowable Error (TEa) set by the National Glycohemoglobin Standardization Program (NGSP) for HbA1c is 6%.The acceptable evaluation method is where TEcalc is less than TEa. RESULTS: The Precision studies were satisfactory with Coefficient of Variation (%CV) being less than 4% for both techniques. Mean HbA1c levels were slightly higher from HPLC than PEIT 9.07 ± 2.23% and 8.93 ± 2.10% respectively, although the difference was minimal. RE was 1.41%, TEcalc was 1.55%, which was less than TEa set by the NGSP. Both methods strongly correlated with the correlation coefficient (r) 0.9716, p < 0.0001.
Conclusion: Our study showed HbA1c analysis by PEIT technique is precise, accurate, rapid and convenient and can be employed as an alternative to HPLC technique in countries where cost is a major problem for diagnosis and treatment.
期刊介绍：
Clinical Diabetes and Endocrinology is an open access journal publishing within the field of diabetes and endocrine disease. The journal aims to provide a widely available resource for people working within the field of diabetes and endocrinology, in order to improve the care of people affected by these conditions. The audience includes, but is not limited to, physicians, researchers, nurses, nutritionists, pharmacists, podiatrists, psychologists, epidemiologists, exercise physiologists and health care researchers. Research articles include patient-based research (clinical trials, clinical studies, and others), translational research (translation of basic science to clinical practice, translation of clinical practice to policy and others), as well as epidemiology and health care research. Clinical articles include case reports, case seminars, consensus statements, clinical practice guidelines and evidence-based medicine. Only articles considered to contribute new knowledge to the field will be considered for publication.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
