Bo Yuan , Wei Yang , Na Zhang , Hongyan Shi , Shuangpeng Dong
{"title":"新型糖化血红蛋白临床分析试剂及色谱柱在Tosoh HLC-723G8分析仪上的评价","authors":"Bo Yuan , Wei Yang , Na Zhang , Hongyan Shi , Shuangpeng Dong","doi":"10.1016/j.plabm.2023.e00338","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>To evaluate the performance of newly developed glycated hemoglobin (HbA1c) clinical analytic reagents and HPLC columns, applied on Tosoh HLC-723 G8 Analyzer.</p></div><div><h3>Methods</h3><p>Newly developed reagents and columns were used on a Tosoh HLC-723 G8 Analyzer (standard mode) system to measure both of qulity contorls and the clinical blood samples to evaluate the performances of these newly developed prodcuts including precision, accuracy, linearity, carryover, bias evaluation, correlation with commercial reagents, and stability according to CLSI recommendations.</p></div><div><h3>Results</h3><p>The <em>CV</em> of intra-assay precision and inter-assay precision of quality control and clinical blood sample assays using Lirimax products were both less than 3.00%. And the REs of accuracy were less than 6.00%. Linearity: R<sup>2</sup> = 0.9993 in the concentration range 4.77%–14.67%. Carryover: 0.05%. The Bland-Altman mean difference: −0.003583% HbA1c (CI: 0.07398: −0.08115); Passing-Bablok regression: y = 1.0022(0.9984:1.006)x-0.01097(-0.03776: 0.01582), R<sup>2</sup> = 0.9996. Stability evaluation was also acceptable.</p></div><div><h3>Conclusion</h3><p>The performance of newly developed products was well evaluated for HbA1c measurement on a TOSOH G8 Analyzer which shows excellent suitability for clinical assay.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"37 ","pages":"Article e00338"},"PeriodicalIF":1.7000,"publicationDate":"2023-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10582560/pdf/","citationCount":"0","resultStr":"{\"title\":\"Evaluation of newly-developed glycated hemoglobin clinical analytic reagents and chromatography column on Tosoh HLC-723 G8 Analyzer\",\"authors\":\"Bo Yuan , Wei Yang , Na Zhang , Hongyan Shi , Shuangpeng Dong\",\"doi\":\"10.1016/j.plabm.2023.e00338\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>To evaluate the performance of newly developed glycated hemoglobin (HbA1c) clinical analytic reagents and HPLC columns, applied on Tosoh HLC-723 G8 Analyzer.</p></div><div><h3>Methods</h3><p>Newly developed reagents and columns were used on a Tosoh HLC-723 G8 Analyzer (standard mode) system to measure both of qulity contorls and the clinical blood samples to evaluate the performances of these newly developed prodcuts including precision, accuracy, linearity, carryover, bias evaluation, correlation with commercial reagents, and stability according to CLSI recommendations.</p></div><div><h3>Results</h3><p>The <em>CV</em> of intra-assay precision and inter-assay precision of quality control and clinical blood sample assays using Lirimax products were both less than 3.00%. And the REs of accuracy were less than 6.00%. Linearity: R<sup>2</sup> = 0.9993 in the concentration range 4.77%–14.67%. Carryover: 0.05%. The Bland-Altman mean difference: −0.003583% HbA1c (CI: 0.07398: −0.08115); Passing-Bablok regression: y = 1.0022(0.9984:1.006)x-0.01097(-0.03776: 0.01582), R<sup>2</sup> = 0.9996. Stability evaluation was also acceptable.</p></div><div><h3>Conclusion</h3><p>The performance of newly developed products was well evaluated for HbA1c measurement on a TOSOH G8 Analyzer which shows excellent suitability for clinical assay.</p></div>\",\"PeriodicalId\":20421,\"journal\":{\"name\":\"Practical Laboratory Medicine\",\"volume\":\"37 \",\"pages\":\"Article e00338\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2023-10-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10582560/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Practical Laboratory Medicine\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S235255172300032X\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Practical Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S235255172300032X","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
Evaluation of newly-developed glycated hemoglobin clinical analytic reagents and chromatography column on Tosoh HLC-723 G8 Analyzer
Objective
To evaluate the performance of newly developed glycated hemoglobin (HbA1c) clinical analytic reagents and HPLC columns, applied on Tosoh HLC-723 G8 Analyzer.
Methods
Newly developed reagents and columns were used on a Tosoh HLC-723 G8 Analyzer (standard mode) system to measure both of qulity contorls and the clinical blood samples to evaluate the performances of these newly developed prodcuts including precision, accuracy, linearity, carryover, bias evaluation, correlation with commercial reagents, and stability according to CLSI recommendations.
Results
The CV of intra-assay precision and inter-assay precision of quality control and clinical blood sample assays using Lirimax products were both less than 3.00%. And the REs of accuracy were less than 6.00%. Linearity: R2 = 0.9993 in the concentration range 4.77%–14.67%. Carryover: 0.05%. The Bland-Altman mean difference: −0.003583% HbA1c (CI: 0.07398: −0.08115); Passing-Bablok regression: y = 1.0022(0.9984:1.006)x-0.01097(-0.03776: 0.01582), R2 = 0.9996. Stability evaluation was also acceptable.
Conclusion
The performance of newly developed products was well evaluated for HbA1c measurement on a TOSOH G8 Analyzer which shows excellent suitability for clinical assay.
期刊介绍：
Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.
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