Salvagno G L, Lippi G, Montagnana M, Franchini M, Poli G, Guidi G C
Sezione di Chimica e Microscopia Clinica, Dipartimento di Scienze Morfologico-Biomediche, Università degli Studi di Verona, Verona, Italy.
Int J Lab Hematol. 2009 Aug;31(4):462-7. doi: 10.1111/j.1751-553X.2008.01058.x. Epub 2008 Mar 21.
The accurate standardization of the preanalytical phase is of pivotal importance for achieving reliable results of coagulation tests. Because information on the suitable storage conditions for coagulation testing is controversial, we aimed at investigating the sample stability with regard to the temperature and time before centrifugation. The activated partial thromboplastin time (aPTT), prothrombin time (PT), fibrinogen and D-dimer were assayed in specimens collected from 26 consecutive patients on antivitamin K therapy on the ACL TOP analyzer. Three primary 3.6-ml siliconized evacuated tubes containing 0.109 mol/l buffered trisodium citrate were sequentially collected from each patient. These three tubes were mixed, pooled and divided into seven identical aliquots. The first aliquot was immediately centrifuged according to the standard protocol [1500 g for 15 min at room temperature (RT)] and analyzed. The other aliquots were left for 3, 6 and 24 h, respectively, at RT or 4 degrees C, and then centrifuged and analyzed. Test results were compared with those obtained on the reference specimen. Statistically significant prolongations were observed for aPTT in all the samples. Such differences exceeded the analytical quality specifications for desirable bias in the samples stored for 24 h. A significant reduction, yet comprised within the desirable bias, was observed for PT and fibrinogen in uncentrifuged specimens stored at RT for 3 and 6 h. No significant biases could be recorded in D-dimer. In conclusion, a 6-h storage of uncentrifuged specimens at either RT or 4 degrees C may still be suitable to achieve results of routine coagulation testing comprised within the analytical quality specifications for desirable bias.
分析前阶段的准确标准化对于获得可靠的凝血试验结果至关重要。由于关于凝血检测合适储存条件的信息存在争议,我们旨在研究离心前样本在温度和时间方面的稳定性。在ACL TOP分析仪上,对26例接受抗维生素K治疗的连续患者采集的标本进行活化部分凝血活酶时间(aPTT)、凝血酶原时间(PT)、纤维蛋白原和D-二聚体检测。从每位患者依次采集3支含0.109 mol/l缓冲枸橼酸钠的3.6 ml硅化真空采血管。将这3支采血管混合、合并并分成7个相同的等分试样。第一个等分试样立即按照标准方案[室温(RT)下1500 g离心15分钟]进行离心并分析。其他等分试样分别在RT或4℃下放置3、6和24小时,然后离心并分析。将测试结果与参考标本获得的结果进行比较。在所有样本中均观察到aPTT有统计学意义的延长。对于储存24小时的样本,这种差异超过了预期偏差的分析质量规范。在RT下储存3和6小时的未离心标本中,PT和纤维蛋白原出现了显著降低,但仍在预期偏差范围内。D-二聚体未记录到显著偏差。总之,未离心标本在RT或4℃下储存6小时可能仍适合获得在预期偏差分析质量规范范围内的常规凝血试验结果。