Evaluation of newly-developed glycated hemoglobin clinical analytic reagents and chromatography column on Tosoh HLC-723 G8 Analyzer

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine Pub Date : 2023-10-05 DOI:10.1016/j.plabm.2023.e00338

Bo Yuan , Wei Yang , Na Zhang , Hongyan Shi , Shuangpeng Dong

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引用次数: 0

Abstract

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.

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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

目的评价新型糖化血红蛋白（HbA1c）临床分析试剂和高效液相色谱柱的性能，方法在Tosoh HLC-723 G8分析仪（标准模式）系统上使用新开发的试剂和柱来测量质量控制和临床血液样本，以评估这些新开发产品的性能，包括精密度、准确性、线性、结转、偏差评估、与商业试剂的相关性，以及CLSI建议的稳定性。结果Lirimax产品质量控制和临床血样测定的批内精密度和批间精密度的CV均小于3.00%。准确度的RE均小于6.00%。线性关系：R2=0.993，浓度范围4.77%-14.67%。结转率：0.05%。Bland-Altman平均差：−0.003583%HbA1c（CI:0.07398:−0.08115）；通过Bablok回归：y=1.0022（0.9984:1.006）x-0.01097（-0.03776:0.01582），R2=0.9996。稳定性评估也是可以接受的。结论在TOSOH G8分析仪上对新开发的产品的HbA1c测定性能进行了良好的评价，表明该产品具有良好的临床应用价值。

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来源期刊

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

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.