Analytical performance evaluation of the GreenCare A1c and Cera-Stat HbA1c point-of-care testing assays.

IF 2.1 4区医学 Q3 MEDICAL LABORATORY TECHNOLOGY Annals of Clinical Biochemistry Pub Date : 2024-09-23 DOI:10.1177/00045632241282580

Joon Hee Lee, Sun-Hee Jun, Jikyo Lee, Sang Hoon Song, Kyunghoon Lee

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Abstract

Background: The escalating prevalence of diabetes underscores the need for precise diagnostic tools to facilitate effective management. Hemoglobin A1c (HbA1c) is a crucial biomarker for long-term glycemic control in diabetic patients. Point-of-care testing (POCT) for HbA1c offers rapid, accessible alternatives to conventional laboratory methods, but uncertainties persist regarding the accuracy and reliability of POCT assays.

Methods: This study evaluates the analytical performance of two boronate-affinity based HbA1c POCT assays, the GreenCare A1c and Cera-Stat HbA1c. Various analytical parameters including precision, linearity, comparison, and accuracy are assessed following guidelines from Clinical and Laboratory Standards Institute (CLSI), with results applied to certification criteria from the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Furthermore, 52 and 13 frozen EDTA whole blood samples were respectively used for additional evaluation of accuracy and interference due to Hb variants for the GreenCare A1c assay.

Results: Both GreenCare and Cera-Stat demonstrated good precision (repeatability CV% 1.5-1.9 and total imprecision CV% 1.6-2.2), linearity (R² = 0.9996 & 0.9990), and correlation (r = 0.982 & 0.978) with an established HbA1c analyzer, the Bio-Rad D100. The GreenCare also exhibited good accuracy with frozen EDTA samples with known HbA1c values. Both assays met the certification criteria from NGSP and IFCC, classifying them as "standard" according to IFCC model for quality targets for HbA1c.

Conclusions: This evaluation affirms the reliability of GreenCare and Cera-Stat POCT assays for HbA1c measurements, which can potentially reduce unnecessary referrals and enhance the overall quality of diabetes diagnosis and treatment.

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GreenCare A1c 和 Cera-Stat HbA1c 床旁检测试剂盒的分析性能评估。

背景糖尿病发病率的不断攀升凸显了对精确诊断工具的需求，以促进有效的管理。血红蛋白 A1c（HbA1c）是糖尿病患者长期血糖控制的重要生物标志物。HbA1c 的床旁检测（POCT）为传统实验室方法提供了快速、便捷的替代方法，但 POCT 检测的准确性和可靠性仍存在不确定性。方法本研究评估了两种基于硼酸盐亲和力的 HbA1c POCT 检测方法（GreenCare A1c 和 Cera-Stat HbA1c）的分析性能。根据临床和实验室标准协会（CLSI）的指南评估了各种分析参数，包括精确度、线性度、比较度和准确度，并将评估结果应用于国家糖化血红蛋白标准化计划（NGSP）和国际临床化学和实验室医学联合会（IFCC）的认证标准。此外，还分别使用了 52 份和 13 份冷冻 EDTA 全血样本，对 GreenCare A1c 检测法的准确性和血红蛋白变体的干扰进行了额外评估。结果 GreenCare 和 Cera-Stat 均表现出良好的精确度（重复性 CV% 1.5-1.9 和总不精确度 CV% 1.6-2.2）、线性度（R2= 0.9996 和 0.9990）以及与成熟的 HbA1c 分析仪 Bio-Rad D100 的相关性（r= 0.982 和 0.978）。对于已知 HbA1c 值的冷冻 EDTA 样品，GreenCare 也表现出良好的准确性。这两种检测方法都符合 NGSP 和 IFCC 的认证标准，根据 IFCC 的 HbA1c 质量目标模型，可将其归类为 "标准"。结论本次评估证实了 GreenCare 和 Cera-Stat POCT 检测仪测量 HbA1c 的可靠性，这有可能减少不必要的转诊，提高糖尿病诊断和治疗的整体质量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annals of Clinical Biochemistry Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry

CiteScore

5.20

自引率

4.50%

发文量

期刊介绍： Annals of Clinical Biochemistry is the fully peer reviewed international journal of the Association for Clinical Biochemistry and Laboratory Medicine. Annals of Clinical Biochemistry accepts papers that contribute to knowledge in all fields of laboratory medicine, especially those pertaining to the understanding, diagnosis and treatment of human disease. It publishes papers on clinical biochemistry, clinical audit, metabolic medicine, immunology, genetics, biotechnology, haematology, microbiology, computing and management where they have both biochemical and clinical relevance. Papers describing evaluation or implementation of commercial reagent kits or the performance of new analysers require substantial original information. Unless of exceptional interest and novelty, studies dealing with the redox status in various diseases are not generally considered within the journal''s scope. Studies documenting the association of single nucleotide polymorphisms (SNPs) with particular phenotypes will not normally be considered, given the greater strength of genome wide association studies (GWAS). Research undertaken in non-human animals will not be considered for publication in the Annals. Annals of Clinical Biochemistry is also the official journal of NVKC (de Nederlandse Vereniging voor Klinische Chemie) and JSCC (Japan Society of Clinical Chemistry).