Undefilled blood tube containing EDTA: Is it an inappropriate sample for HbA1c assay?

IF 3.8 3区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Biochemia Medica Pub Date : 2023-02-15 DOI:10.11613/BM.2023.010901

Berrak Guven, Ismail Benice, Murat Can

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引用次数: 0

Abstract

Introduction: Blood samples having inappropriate volume are a substantial part of preanalytical errors. Inadequate sample volume for glycated haemoglobin (HbA1c) test may be a common problem of patients with diabetes mellitus having vascular changes. In this study, we compared HbA1c concentrations of underfilled and appropriately filled blood collection tubes.

Materials and methods: To compare HbA1c concentrations, blood samples were collected into 2 mL tubes containing K3-EDTA from 109 subjects. Two blood samples (underfilled and appropriately filled) were drawn from a patient by the same personnel and materials. HbA1c measurements were assayed on a Cobas 6000 analyser module c 501 (Roche Diagnostics, Mannheim, Germany). The HbA1c% results were compared by t-test and Wilcoxon's signed-rank statistical methods (SPSS Inc., Chicago, USA). Bias analysis was performed using Microsoft Excel 4.0.

Results: Underfilled samples were classified three groups (group 1, N = 44; group 2, N = 36; and group 3, N = 29) according to the filling ratio of the samples; 0.5 mL and below (< 25%), 0.5-1.0 mL (25-50%), and 1.0-2.0 mL (> 50%), respectively. When we compared underfilled tubes with pairing filled tubes, there was a statistically significant difference only with tubes filled less than 25% (P = 0.030). Furthermore, we have done bias analysis between paired tubes according to the diagnostic cut-off value of 6.5%. The bias was more prominent in up to 50% underfilled blood tubes (1.1%), when HbA1c concentrations were below the diagnostic cut-off of 6.5%.

Conclusions: We suggest that the blood tubes with EDTA for HbA1c measurement should be filled with at least 50% to avoid clinical variations.

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含EDTA的未灌注血管:是否不适合用于糖化血红蛋白检测?

血液样本容量不合适是分析前错误的重要组成部分。糖化血红蛋白(HbA1c)检测样本量不足可能是伴有血管改变的糖尿病患者的常见问题。在本研究中，我们比较了未充血和充血适当的采集管的HbA1c浓度。材料与方法:为比较HbA1c浓度，109例受试者采集血样至2ml含K3-EDTA管中。由相同的人员和材料从患者身上抽取两份血液样本(未充分填充和适当填充)。HbA1c测量在Cobas 6000分析仪模块c501(罗氏诊断，曼海姆，德国)上进行分析。HbA1c%结果采用t检验和Wilcoxon's signed-rank统计方法(SPSS Inc.， Chicago, USA)进行比较。使用Microsoft Excel 4.0进行偏倚分析。结果:未充份标本分为3组(1组，N = 44;第二组，N = 36;第3组，N = 29);0.5 mL及以下(< 25%)，0.5-1.0 mL (25-50%)， 1.0-2.0 mL(> 50%)。当我们比较未充液管与配对充液管时，只有充液管小于25%时，差异才有统计学意义(P = 0.030)。此外，我们根据6.5%的诊断临界值对配对管进行了偏倚分析。当HbA1c浓度低于6.5%的诊断临界值时，这种偏差在高达50%的未充血管(1.1%)中更为突出。结论:我们建议使用EDTA检测HbA1c的血管应至少填充50%，以避免临床变异。

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

Biochemia Medica 医学-医学实验技术

CiteScore

5.50

自引率

3.00%

发文量

审稿时长

>12 weeks

期刊介绍： Biochemia Medica is the official peer-reviewed journal of the Croatian Society of Medical Biochemistry and Laboratory Medicine. Journal provides a wide coverage of research in all aspects of clinical chemistry and laboratory medicine. Following categories fit into the scope of the Journal: general clinical chemistry, haematology and haemostasis, molecular diagnostics and endocrinology. Development, validation and verification of analytical techniques and methods applicable to clinical chemistry and laboratory medicine are welcome as well as studies dealing with laboratory organization, automation and quality control. Journal publishes on a regular basis educative preanalytical case reports (Preanalytical mysteries), articles dealing with applied biostatistics (Lessons in biostatistics) and research integrity (Research integrity corner).