Department of Clinical Biochemistry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Department of Technology, Faculty of Health, University College Copenhagen, Copenhagen, Denmark.
Int J Lab Hematol. 2022 Apr;44(2):273-280. doi: 10.1111/ijlh.13748. Epub 2021 Nov 1.
Differential counts of leukocytes are frequent, and often several automated blood cell counters are needed in contemporary laboratories. However, these modules are often individually quality assured. Our aim was therefore to validate the interchangeability of five hematology modules in a large modern laboratory and to compare them with our gold standard (GS) manual white blood cell differential count.
At Copenhagen University Hospital, we compared five Sysmex XN-modules for neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes (IG). We analyzed control samples in three levels to evaluate intra- and intermodular precision. Bias between modules was evaluated by analyzing 93 random patient samples within reference intervals. XN-modules' mean counts were compared with GS.
We found acceptable intramodular CV% (0.92%-8.76%), only neutrophils and eosinophils exceeded state-of-the-art imprecision or desirable specifications for medium control levels. Intermodular CV% showed significance difference for only monocytes (ANOVA, P < .0001). For patient samples, there were significant differences between XN-modules regarding four WBC types (ANOVA); however, proportional bias ranged from 1.7% to 3.8%, being within desirable specifications except basophils and IG (bias = 13.3% and 24.9%, respectively). Comparisons with GS, XN-modules exceeded desirable bias for basophils (lower than GS); monocytes and IG (higher than GS).
This multimodule comparison shows acceptable intermodular imprecision and bias for clinical purposes, which is important for patient safety. Similar multimodule study should be performed with samples out of reference range in large-scale laboratories to confirm the interchangeability.
白细胞分类计数很常见，当代实验室通常需要多个自动化血细胞计数器。然而，这些模块通常是单独进行质量保证的。因此，我们的目的是验证大型现代化实验室中五个血液学模块的可互换性，并将其与我们的金标准（GS）手动白细胞分类计数进行比较。
在哥本哈根大学医院，我们比较了五个 Sysmex XN 模块的中性粒细胞、淋巴细胞、单核细胞、嗜酸性粒细胞、嗜碱性粒细胞和未成熟粒细胞（IG）。我们在三个水平上分析对照样本，以评估模块内和模块间的精密度。通过分析 93 例参考区间内的随机患者样本来评估模块间的偏差。XN 模块的平均计数与 GS 进行比较。
我们发现可接受的模块内 CV%（0.92%-8.76%），只有中性粒细胞和嗜酸性粒细胞超过了当前的不精密度或中等对照水平的理想规格。仅单核细胞的模块间 CV%存在显著差异（ANOVA，P<0.0001）。对于患者样本，XN 模块之间在四种白细胞类型上存在显著差异（ANOVA）；然而，比例偏差范围为 1.7%至 3.8%，除了嗜碱性粒细胞和 IG（偏差分别为 13.3%和 24.9%）之外，都在理想规格内。与 GS 相比，XN 模块对嗜碱性粒细胞（低于 GS）；单核细胞和 IG（高于 GS）的偏差超过了理想值。
这种多模块比较显示出可接受的模块间不精密度和偏差，适用于临床目的，这对于患者安全很重要。在大型实验室中，应该使用参考范围外的样本进行类似的多模块研究，以确认可互换性。
