Are tube fill volumes below 90% a rejection criterion for all coagulation tests?

Merve Sena Odabasi, Zeynep Mine Yalcinkaya Kara
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Abstract

Background: Rejected samples lead to prolonged turnaround time and delayed diagnosis and treatment of patients. This study was conducted to determine minimum acceptable sample volume in Sarstedt brand coagulation tubes to reduce high sample rejection rate.

Methods: Blood samples were drawn from 20 participants (10 healthy volunteers and 10 patients receiving oral anticoagulant) into coagulation tubes. Six samples were taken from each participant, with tube fill volumes of 100%, 90%, 80%, 70%, 60%, and 50%. Prothrombin time (PT), active partial thromboplastin time (aPTT), and fibrinogen tests were analyzed.

Results: According to quality performance specifications, the tube fill volume must be at least 70% for PT and aPTT and 50% for fibrinogen. There was no statistical difference in samples from healthy volunteers for PT, aPTT, and fibrinogen tests when the minimum tube fill volume was at least 80%, 90%, and 50%, respectively. These percentages were 50%, 70%, and 60%, respectively, in patients receiving oral anticoagulant.

Conclusions: Sarstedt tubes meet quality standard specifications at a 70% fill rate for PT and aPTT and a 50% fill rate for fibrinogen. Comprehensive studies with larger populations are needed to accept these values as sample acceptance criteria for the laboratory.

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试管填充量低于 90% 是否是所有凝血试验的剔除标准?
背景:样本被拒会导致周转时间延长,延误对患者的诊断和治疗。本研究旨在确定 Sarstedt 牌凝血试管中可接受的最小样本量,以降低高样本拒收率:方法:从 20 名参与者(10 名健康志愿者和 10 名接受口服抗凝剂治疗的患者)中抽取血液样本放入凝血管中。每位参与者抽取 6 份样本,试管填充量分别为 100%、90%、80%、70%、60% 和 50%。对凝血酶原时间(PT)、活性部分凝血活酶时间(aPTT)和纤维蛋白原检测结果进行了分析:根据质量性能规范,PT 和 aPTT 的试管填充量必须至少达到 70%,纤维蛋白原必须达到 50%。当最小试管填充量分别至少为 80%、90% 和 50%时,健康志愿者样本的 PT、aPTT 和纤维蛋白原测试结果没有统计学差异。在口服抗凝剂的患者中,这些百分比分别为 50%、70% 和 60%:结论:Sarstedt 管符合质量标准规格,PT 和 aPTT 的填充率为 70%,纤维蛋白原的填充率为 50%。要将这些数值作为实验室的样本验收标准,还需要对更多人群进行全面研究。
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