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管腔填充体积低于 90% 是否是所有凝血测试的拒绝标准?

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

作者信息

Sena Odabasi Merve, Yalcinkaya Kara Zeynep Mine

机构信息

Department of Biochemistry, Sisli Hamidiye Etfal Research and Training Hospital, Istanbul, Turkey.

出版信息

Lab Med. 2024 Jul 3;55(4):442-446. doi: 10.1093/labmed/lmad108.

DOI:10.1093/labmed/lmad108
PMID:38104249
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.

摘要

背景

拒收样本会导致周转时间延长,并延误患者的诊断和治疗。本研究旨在确定 Sarstedt 品牌凝血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)中抽取血液样本至凝血管中。每位参与者抽取 6 份样本,管内填充体积分别为 100%、90%、80%、70%、60%和 50%。分析凝血酶原时间(PT)、活化部分凝血活酶时间(aPTT)和纤维蛋白原检测结果。

结果

根据质量性能规范,PT 和 aPTT 的管内填充体积必须至少为 70%,纤维蛋白原的管内填充体积必须至少为 50%。当最小管内填充体积分别至少为 80%、90%和 50%时,健康志愿者的样本在 PT、aPTT 和纤维蛋白原检测中没有统计学差异。在接受口服抗凝剂治疗的患者中,这一比例分别为 50%、70%和 60%。

结论

Sarstedt 管在 70%填充率时符合 PT 和 aPTT 的质量标准规范,在 50%填充率时符合纤维蛋白原的质量标准规范。需要进行更广泛人群的综合研究,以接受这些值作为实验室样本接受标准。