Lack of consensus in inter-laboratory haematology results in selected laboratories in the southern and northern zones of Ghana.

Ibrahim B Halidu, Amos X Gafa, Samuel D K Blanney, Benjamin T Barimah, David Akan-Enge, Joseph Boachie, Kate A Kontor, Patrick Adu
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Abstract

Objective: To assess the inter-laboratory comparability and intra-assay reproducibility of full blood count (FBC) results.

Design: Exploratory cross-sectional study.

Setting: Three and two selected medical laboratories in the northern and southern zones, respectively.

Participants: Forty-nine individuals per zone; 16 type 2 diabetes mellitus, 16 with HbAS haemoglobin type and 17 normal samples.

Intervention: Each sample was run eleven times through the analysers in the participating laboratories to evaluate intra-laboratory reproducibility and comparability of FBC results.

Main outcome measure: Intra-laboratory reproducibility was evaluated using %coefficient variation (%CV). Interlaboratory comparisons were assessed through t-test or One-Way ANOVA for two-sample and three-sample tests. All statistical testing was undertaken using the two-tailed assumption.

Result: Statistically significantly different haemoglobin levels were estimated in both northern and southern zones (mean difference 0.00 g/dL to 3.75 g/dL vs 0.18 g/dL to 1.92 g/dL respectively). Also, total WBC counts significantly differed across laboratories in both northern and southern zones (mean difference 0.15 ×109/L - 3.86 ×109/L vs 0.02 ×109/L to 1.39 ×109/L respectively). Furthermore, platelet counts significantly differed across the participating laboratories in the northern and southern zones (mean difference 0.40 ×109/L to 299.76 ×109/L vs 5.7 ×109/L to 76.9 ×109/L respectively). Moreover, there was evidence of non-reproducibility of results within the respective laboratories in each zone as the respective %CV were outside the acceptable limits.

Conclusion: The intra-laboratory non-reproducibility and inter-laboratory non-comparability of FBC results highlight the need to establish a national quality assessment scheme to harmonise laboratory practices nationwide.

Funding: This study was funded by the University of Cape Coast Individual-Led Research Support Grant (RSG-INDI-CoHAS-2019-107).

加纳南部和北部选定实验室的血液学结果缺乏共识。
目的:评估全血细胞计数(FBC)结果的实验室间可比性和测定内重现性:评估全血细胞计数(FBC)结果的实验室间可比性和测定内可重复性:设计:探索性横断面研究:研究地点:北部和南部地区分别选定的三家和两家医学实验室:每个区 49 人;16 名 2 型糖尿病患者、16 名 HbAS 血红蛋白类型患者和 17 名正常样本:干预措施:每个样本在参与实验室的分析仪上运行 11 次,以评估 FBC 结果的实验室内重现性和可比性。实验室间的比较通过 t 检验或单向方差分析进行双样本和三样本检验。所有统计检验均采用双尾假设:结果:据统计,北部和南部地区的血红蛋白水平存在明显差异(平均差异分别为 0.00 g/dL 至 3.75 g/dL 与 0.18 g/dL 至 1.92 g/dL)。北部和南部地区各实验室的白细胞总数也存在显著差异(平均差异分别为 0.15 ×109/L - 3.86 ×109/L vs 0.02 ×109/L - 1.39 ×109/L)。此外,北部和南部地区参与实验室的血小板计数也存在显著差异(平均差异分别为 0.40 ×109/L - 299.76 ×109/L vs 5.7 ×109/L - 76.9 ×109/L)。此外,有证据表明,各区实验室内的结果不具有重现性,因为各自的%CV 都超出了可接受的范围:结论:实验室内FBC结果的不可再现性和实验室间的不可比性突出表明,有必要建立国家质量评估计划,以统一全国的实验室操作:本研究由海岸角大学个人主导研究支持拨款(RSG-INDI-CoHAS-2019-107)资助。
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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