Gosselin R C, Estacio E E, Song J Y, Dwyre D M
Department of Pathology and Laboratory Medicine, UC Davis Health System, Sacramento, CA, USA.
Department of Pathology, City of Hope National Medical Center, Los Angeles, CA, USA.
Int J Lab Hematol. 2016 Apr;38(2):183-92. doi: 10.1111/ijlh.12464. Epub 2016 Feb 5.
To verify the manufacturer performance claims of the TEG5000 with traditional laboratory methods.
Samples were concurrently measured using the TEG5000 analyzer and either PT, APTT, fibrinogen, factor activities, platelet count, or platelet function testing using whole blood or platelet-rich plasma methods.
Within-run imprecision yielded coefficient of variation (CV) of <5%. There was no correlation of PT or APTT with R time. Only Factor VIII and factor XII activity significantly correlated with R time. There was significant correlation between k and angle with FBG, PLT count, and factor levels. There was weak inverse correlation between angle results and measures of platelet function. All laboratory methods were significantly correlated with MA. There were significant differences between citrated whole blood and fresh citrated plasma for angle and MA, and between fresh and frozen plasma for R time and MA. We demonstrated a high % inhibition noted with normal, drug naïve donors, especially with ADP PLT mapping (50% inhibition), but less so with AA PLT mapping (20% inhibition). For TEG platelet mapping, 19/22 (86.3%) and 17/22 (77.3%) results were concordant with traditional aggregation results.
We demonstrated both the lack of, and strong correlation between laboratory tests and the TEG parameters.
用传统实验室方法验证血栓弹力图仪（TEG5000）制造商的性能声明。
使用TEG5000分析仪，同时采用全血或富血小板血浆方法对样本进行凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、纤维蛋白原、因子活性、血小板计数或血小板功能检测。
批内不精密度产生的变异系数（CV）<5%。PT或APTT与R时间无相关性。仅因子VIII和因子XII活性与R时间显著相关。k和角度与纤维蛋白原（FBG）、血小板计数（PLT）及因子水平之间存在显著相关性。角度结果与血小板功能检测指标之间存在弱负相关。所有实验室方法与最大振幅（MA）均显著相关。枸橼酸盐抗凝全血与新鲜枸橼酸盐血浆在角度和MA方面存在显著差异，新鲜血浆与冷冻血浆在R时间和MA方面存在显著差异。我们发现，正常、未使用过药物的供者存在较高的抑制率，尤其是在二磷酸腺苷（ADP）血小板功能检测图中（50%抑制），但在花生四烯酸（AA）血小板功能检测图中抑制率较低（20%抑制）。对于TEG血小板功能检测图，19/22（86.3%）和17/22（77.3%）的结果与传统凝集结果一致。
我们证明了实验室检测与TEG参数之间既缺乏相关性，又存在强相关性。
