Department of Medical Laboratory Science, School of Allied Health Sciences, University of Cape Coast, Ghana.
Department of Biomedical Sciences, School of Allied Health Sciences, University of Cape Coast, Ghana.
Ghana Med J. 2023 Sep;57(3):210-217. doi: 10.4314/gmj.v57i3.8.
To assess the inter-laboratory comparability and intra-assay reproducibility of full blood count (FBC) results.
Exploratory cross-sectional study.
Three and two selected medical laboratories in the northern and southern zones, respectively.
Forty-nine individuals per zone; 16 type 2 diabetes mellitus, 16 with HbAS haemoglobin type and 17 normal samples.
Each sample was run eleven times through the analysers in the participating laboratories to evaluate intra-laboratory reproducibility and comparability of FBC results.
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.
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 ×10/L - 3.86 ×10/L vs 0.02 ×10/L to 1.39 ×10/L respectively). Furthermore, platelet counts significantly differed across the participating laboratories in the northern and southern zones (mean difference 0.40 ×10/L to 299.76 ×10/L vs 5.7 ×10/L to 76.9 ×10/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.
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.
This study was funded by the University of Cape Coast Individual-Led Research Support Grant (RSG-INDI-CoHAS-2019-107).
评估全血细胞计数(FBC)结果的实验室间可比性和室内精密度。
探索性横断面研究。
分别在北部和南部两个选定的医疗实验室。
每个区域各 49 人;16 例 2 型糖尿病患者,16 例血红蛋白 AS 型,17 例正常样本。
每个样本在参与实验室的分析仪上运行 11 次,以评估室内精密度和 FBC 结果的可比性。
室内精密度用变异系数(%CV)评估。通过 t 检验或 One-Way ANOVA 对两样本和三样本检验进行实验室间比较。所有统计检验均采用双侧假设。
北部和南部区域均估计出血红蛋白水平存在统计学显著差异(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)。此外,北部和南部区域的总白细胞计数在实验室间也存在显著差异(平均差异分别为 0.15×10/L 至 3.86×10/L 与 0.02×10/L 至 1.39×10/L)。此外,北部和南部区域的血小板计数在参与实验室间也存在显著差异(平均差异分别为 0.40×10/L 至 299.76×10/L 与 5.7×10/L 至 76.9×10/L)。此外,由于各自区域的 %CV 超出可接受范围,表明各实验室内部结果的重复性不可靠。
FBC 结果的实验室内部重复性和实验室间可比性差,突出表明需要建立国家质量评估计划,以协调全国范围内的实验室实践。
本研究由开普敦大学个人领导研究支持赠款(RSG-INDI-CoHAS-2019-107)资助。