Clinical Chemistry Laboratory, Abele Ajello Hospital, Mazara del Vallo, Italy.
Medicine Laboratory, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
Int J Lab Hematol. 2020 Oct;42(5):552-564. doi: 10.1111/ijlh.13204. Epub 2020 Apr 18.
The correctness of the results of automated platelet analysis is still highly debated. The aim of this multicenter study, conducted according to international guidelines, was to verify the analytical performance of nine different types of hematology analyzers (HAs) in the automated platelet analysis.
Four hundred eighty-six peripheral blood samples (PB), collected in K EDTA tubes, were analyzed by ABX Pentra, ADVIA2120i, BC-6800, BC-6800 Plus, Cell-DYN Sapphire, DxH800, XE-2100, XE-5000, XN-20 with PLT-F App. Within-run imprecision and between-run imprecision were carried out using PB and material control, respectively. The carryover, low limit of quantification (LoQ), and the PB stability were evaluated.
The carryover was absent for all HAs. The LoQ of PLT ranged between 2.0 (Cell-Dyn Sapphire) and 25.0 × 10 /L (ADVIA 2120i), while immature platelet fraction (IPF) ranged between 1.0 (XN-20) and 12.0 × 10 /L (XE-5000). The imprecision (%CV) increases as the platelet count decreases. No HAs showed desirable CV for PLT counts less than 50.0 × 10 /L, with the exception of Cell-DYN Sapphire (CV 3.0% with PLT-O mean value of 26.7 × 10 /L), XN-20 (CV 2.4% with PLT-F mean value of 21.5 × 10 /L), and BC-6800 Plus (CV 1.9% with PLT-O mean value of 26.5 × 10 /L). The sample stability ranged between under two hours for MPV by ADVIA2120i and 8 hours for other PLT parameters and HAs.
The findings of this study may provide useful information regarding carryover, precision, and stability of platelet counts and parameters, especially in thrombocytopenic samples. Moreover, the stability of sample for platelet analysis is conditioned by the HA and by temperature and storage time.
自动化血小板分析结果的正确性仍存在较大争议。本多中心研究按照国际指南进行,旨在验证 9 种不同类型的血液分析仪(HA)在自动化血小板分析中的分析性能。
采集 486 例 EDTA-K3 外周血样本,分别用 ABX Pentra、ADVIA2120i、BC-6800、BC-6800 Plus、Cell-DYN Sapphire、DxH800、XE-2100、XE-5000 和 XN-20 加 PLT-F App 进行检测。采用外周血和质控物进行批内和批间不精密度评估,评估仪器交叉污染、定量下限(LoQ)和外周血稳定性。
所有 HA 均无交叉污染。PLT 的 LoQ 范围为 2.0(Cell-DYN Sapphire)25.0×10 /L(ADVIA 2120i),而未成熟血小板分数(IPF)范围为 1.0(XN-20)12.0×10 /L(XE-5000)。血小板计数越低,不精密度(%CV)越高。除 Cell-DYN Sapphire(血小板计数平均值为 26.7×10 /L 时 CV 为 3.0%)、XN-20(血小板计数平均值为 21.5×10 /L 时 CV 为 2.4%)和 BC-6800 Plus(血小板计数平均值为 26.5×10 /L 时 CV 为 1.9%)外,所有 HA 的血小板计数小于 50.0×10 /L 时的 CV 均不理想。MPV 由 ADVIA2120i 检测的样本稳定性在 2 小时以内,其他 PLT 参数和 HA 的样本稳定性在 8 小时以内。
本研究结果可为血小板计数和参数的交叉污染、精密度和稳定性提供有用信息,特别是在血小板减少的样本中。此外,血小板分析样本的稳定性取决于 HA、温度和储存时间。