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Abstract：
UNASSIGNED: To assess the inter-laboratory comparability and intra-assay reproducibility of full blood count (FBC) results.
UNASSIGNED: Exploratory cross-sectional study.
UNASSIGNED: Three and two selected medical laboratories in the northern and southern zones, respectively.
UNASSIGNED: Forty-nine individuals per zone; 16 type 2 diabetes mellitus, 16 with HbAS haemoglobin type and 17 normal samples.
UNASSIGNED: Each sample was run eleven times through the analysers in the participating laboratories to evaluate intra-laboratory reproducibility and comparability of FBC results.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: This study was funded by the University of Cape Coast Individual-Led Research Support Grant (RSG-INDI-CoHAS-2019-107).
UNASSIGNED: Exploratory cross-sectional study.
UNASSIGNED: Three and two selected medical laboratories in the northern and southern zones, respectively.
UNASSIGNED: Forty-nine individuals per zone; 16 type 2 diabetes mellitus, 16 with HbAS haemoglobin type and 17 normal samples.
UNASSIGNED: Each sample was run eleven times through the analysers in the participating laboratories to evaluate intra-laboratory reproducibility and comparability of FBC results.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: This study was funded by the University of Cape Coast Individual-Led Research Support Grant (RSG-INDI-CoHAS-2019-107).
摘要：
■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。
■探索性横断面研究。
■北部和南部地区的三个和两个选定的医学实验室，分别。
■每个区域有49个人；16例2型糖尿病，16个HbAS血红蛋白类型和17个正常样品。
■每个样品通过参与实验室的分析仪运行11次，以评估实验室内FBC结果的可重复性和可比性。
■使用%系数变化(%CV)评估实验室内再现性。实验室间比较通过t检验或单向方差分析评估双样本和三样本检验。所有统计检验均使用双尾假设进行。
■估计北部和南部地区的血红蛋白水平具有统计学上的显着差异（平均差分别为0.00g/dL至3.75g/dL和0.18g/dL至1.92g/dL）。此外，在北部和南部地区的实验室中，WBC总数显着差异（平均差分别为0.15×109/L-3.86×109/L和0.02×109/L至1.39×109/L）。此外，北部和南部地区参与实验室的血小板计数显着差异（平均差分别为0.40×109/L至299.76×109/L，而5.7×109/L至76.9×109/L）。此外，有证据表明,每个区域的相应实验室内的结果不具有可重复性,因为相应的%CV超出了可接受的限度.
■FBC结果的实验室内不可重复性和实验室间不可比性突出表明，需要建立国家质量评估计划，以统一全国的实验室实践。
■这项研究由海岸角大学个人主导研究支持资助（RSG-INDI-CoHAS-2019-107）资助。
■探索性横断面研究。
■北部和南部地区的三个和两个选定的医学实验室，分别。
■每个区域有49个人；16例2型糖尿病，16个HbAS血红蛋白类型和17个正常样品。
■每个样品通过参与实验室的分析仪运行11次，以评估实验室内FBC结果的可重复性和可比性。
■使用%系数变化(%CV)评估实验室内再现性。实验室间比较通过t检验或单向方差分析评估双样本和三样本检验。所有统计检验均使用双尾假设进行。
■估计北部和南部地区的血红蛋白水平具有统计学上的显着差异（平均差分别为0.00g/dL至3.75g/dL和0.18g/dL至1.92g/dL）。此外，在北部和南部地区的实验室中，WBC总数显着差异（平均差分别为0.15×109/L-3.86×109/L和0.02×109/L至1.39×109/L）。此外，北部和南部地区参与实验室的血小板计数显着差异（平均差分别为0.40×109/L至299.76×109/L，而5.7×109/L至76.9×109/L）。此外，有证据表明,每个区域的相应实验室内的结果不具有可重复性,因为相应的%CV超出了可接受的限度.
■FBC结果的实验室内不可重复性和实验室间不可比性突出表明，需要建立国家质量评估计划，以统一全国的实验室实践。
■这项研究由海岸角大学个人主导研究支持资助（RSG-INDI-CoHAS-2019-107）资助。
