血红蛋白变异对迈瑞BS-2800M分析仪酶促糖化血红蛋白检测干扰的研究

IF 6.3 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry Pub Date : 2025-10-02 DOI:10.1093/clinchem/hvaf086.092

Jian Dai, Anping Xu, Houlong Luo, Jin Li, Xiuting Xu, Xian Wang

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Total precision was assessed according to the Clinical and Laboratory Standards Institute (CLSI) EP05-A2 guidelines by using quality control materials and fresh whole blood samples, 8 samples from IFCC was assessed for accuracy. The sigma metric for HbA1c was calculated using the formula s=(TEa-|bias|)/CV. Furthermore, a large number (n=156) of 5 different hemoglobin variants samples were collected and HbA1c results was compared between enzymatic method (Mindray BS-2800M), cation-exchange high-performance liquid chromatography (HPLC) method (D-100), capillary electrophoresis method (Capillarys 3 TERA, C3), boronate affinity method (Premier Hb9210). Results When calculated in NGSP units and sample concentrations ranged from 4.9% to 10.2%, the coefficients of variation (CV) for total precision were between 0.31% to 0.51%. The results of enzymatic assay of whole blood samples of glycosylated hemoglobin assigned by IFCC calibrators were correlated with their target values with slope of 0.998, and the relative biases were all within ±5%. 6.0% was used as the total allowable error for HbA1c, sigma metrics of HbA1c measured by enzymatic assay varied from 11.99 to 19.49 with “world class” quality while sample concentrations ranged from 4.9% to 10.2%. A total of 5 hemoglobin variants types were identified in 156 patients. The most common variant was Hb E(n=85), followed by Hb G(n=30), Hb Q-Thailand (n=17), Hb NewYork (n=12), Hb G-Honolulu(n=12). Mindray enzymatic assay showed great correlation and agreement with D-100,C3,Hb9210. The correlation coefficients were greater than 0.96 and the relative deviations were within 10%? 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引用次数: 0

摘要

HbA1c反映了前2 - 3个月的平均血糖水平。它是筛查和诊断糖尿病，监测糖尿病进展的重要分析物。血红蛋白变异是影响糖化血红蛋白检测的常见干扰因素。本研究旨在评估迈瑞酶法在迈瑞BS-2800M自动分析仪上测量HbA1c的分析性能，特别是在临床实验室常用的四种HbA1c测量方法（HbE、Hb NewYork、Hb G、Hb G- honolulu和Hb Q-Thailand）存在血红蛋白变异干扰的情况下，评估其测量准确性。方法分析性能评价包括精密度和准确度。根据临床和实验室标准协会（CLSI） EP05-A2指南，使用质量控制材料和新鲜全血样本评估总精密度，评估来自IFCC的8个样本的准确性。HbA1c的sigma指标计算公式为s=(TEa-|bias|)/CV。此外，我们收集了5种不同血红蛋白变体的大量样本（n=156），并比较了酶促法（Mindray BS-2800M）、阳离子交换高效液相色谱法（D-100）、毛细管电泳法（capillys 3 TERA, C3）、硼酸盐亲和法（Premier Hb9210）的HbA1c结果。结果在NGSP单位和样品浓度范围为4.9% ~ 10.2%时，总精密度的变异系数（CV）为0.31% ~ 0.51%。IFCC校准器指定的全血糖化血红蛋白酶测结果与目标值相关，斜率为0.998，相对偏差均在±5%以内。采用6.0%作为HbA1c的总允许误差，酶法测定的HbA1c的sigma指标在11.99 ~ 19.49之间，样品浓度在4.9% ~ 10.2%之间，具有“世界级”质量。156例患者共鉴定出5种血红蛋白变异类型。最常见的变异是Hb E(n=85)，其次是Hb G(n=30)， Hb q -泰国（n=17）， Hb纽约（n=12）， Hb G-檀香山（n=12）。迈瑞酶测结果与D-100、C3、Hb9210具有较好的相关性和一致性。相关系数均大于0.96，相对偏差在10%？结论酶法检测HbA1c是一种经济、高效、准确的检测方法，对血红蛋白变异（HbE、Hb NewYork、Hb G、Hb G- honolulu、Hb q - thai）具有良好的抗干扰能力，可为临床实验室提供准确的HbA1c检测结果。适用于大、中、小型临床实验室常规使用。

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A-093 Study of Hemoglobin Variants Interference to Enzymatic HbA1c Assay on Mindray BS-2800M Analyzer

Background HbA1c reflects the average blood glucose level during the preceding 2 to 3 months. It is an important analyte for screening and diagnosing diabetes, and monitoring the diabetes progression. Hemoglobin variants are common interference factors for the HbA1c assay. This study aims to assess the analytical performance of Mindray enzymatic assay for HbA1c measurement on Mindray BS-2800M autoanalyzer, and also, in particular, to evaluate the measurement accurate in the presence of interference of hemoglobin variants (HbE, Hb NewYork, Hb G, Hb G-Honolulu, and Hb Q-Thailand) by four commonly used methods for measuring HbA1c in clinical laboratories. Methods Analytical performance evaluation included precision and accuracy. Total precision was assessed according to the Clinical and Laboratory Standards Institute (CLSI) EP05-A2 guidelines by using quality control materials and fresh whole blood samples, 8 samples from IFCC was assessed for accuracy. The sigma metric for HbA1c was calculated using the formula s=(TEa-|bias|)/CV. Furthermore, a large number (n=156) of 5 different hemoglobin variants samples were collected and HbA1c results was compared between enzymatic method (Mindray BS-2800M), cation-exchange high-performance liquid chromatography (HPLC) method (D-100), capillary electrophoresis method (Capillarys 3 TERA, C3), boronate affinity method (Premier Hb9210). Results When calculated in NGSP units and sample concentrations ranged from 4.9% to 10.2%, the coefficients of variation (CV) for total precision were between 0.31% to 0.51%. The results of enzymatic assay of whole blood samples of glycosylated hemoglobin assigned by IFCC calibrators were correlated with their target values with slope of 0.998, and the relative biases were all within ±5%. 6.0% was used as the total allowable error for HbA1c, sigma metrics of HbA1c measured by enzymatic assay varied from 11.99 to 19.49 with “world class” quality while sample concentrations ranged from 4.9% to 10.2%. A total of 5 hemoglobin variants types were identified in 156 patients. The most common variant was Hb E(n=85), followed by Hb G(n=30), Hb Q-Thailand (n=17), Hb NewYork (n=12), Hb G-Honolulu(n=12). Mindray enzymatic assay showed great correlation and agreement with D-100,C3,Hb9210. The correlation coefficients were greater than 0.96 and the relative deviations were within 10%? Conclusion Enzymatic HbA1c assay is an economical, efficient and accurate detection method, which shows good anti-interference capability from hemoglobin variants (HbE, Hb NewYork, Hb G, HB G-Honolulu, and Hb Q-Thailand) and can provide accurate HbA1c results for clinical laboratories. It is suitable for routine use in large, medium, and small clinical laboratories.

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来源期刊

Clinical chemistry 医学-医学实验技术

CiteScore

11.30

自引率

4.30%

发文量

212

审稿时长

1.7 months

期刊介绍： Clinical Chemistry is a peer-reviewed scientific journal that is the premier publication for the science and practice of clinical laboratory medicine. It was established in 1955 and is associated with the Association for Diagnostics & Laboratory Medicine (ADLM). The journal focuses on laboratory diagnosis and management of patients, and has expanded to include other clinical laboratory disciplines such as genomics, hematology, microbiology, and toxicology. It also publishes articles relevant to clinical specialties including cardiology, endocrinology, gastroenterology, genetics, immunology, infectious diseases, maternal-fetal medicine, neurology, nutrition, oncology, and pediatrics. In addition to original research, editorials, and reviews, Clinical Chemistry features recurring sections such as clinical case studies, perspectives, podcasts, and Q&A articles. It has the highest impact factor among journals of clinical chemistry, laboratory medicine, pathology, analytical chemistry, transfusion medicine, and clinical microbiology. The journal is indexed in databases such as MEDLINE and Web of Science.