Division of Haematological Pathology, Department of Pathology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
National Health Laboratory Service, Tygerberg Hospital, Cape Town, South Africa.
Int J Lab Hematol. 2023 Oct;45(5):707-716. doi: 10.1111/ijlh.14129. Epub 2023 Jul 4.
Verification of blood collection tubes is essential for clinical laboratories. The aim of this study was to assess performance of candidate tubes from four alternative suppliers for routine diagnostic haematology testing during an impending global shortage of blood collection tubes.
A multicentre verification study was performed in Cape Town, South Africa. Blood from 300 healthy volunteers was collected into K EDTA and sodium citrate tubes of BD Vacutainer® comparator tubes and one of four candidate tubes (Vacucare, Vacuette®, V-TUBE™ and Vacutest®). A technical verification was performed, which included tube physical properties and safety. Routine haematology testing was performed for clinical verification.
Vacucare tubes did not have a fill-line indicator, Vacuette® tubes had external blood contamination on the caps post-venesection and Vacutest® tubes had hard rubber stoppers. K EDTA tubes of Vacuette®, Vacucare and Vacutest® performed similarly to the comparator. Unacceptable constant bias was seen for PT in Vacucare (95% CI -2.38 to -0.10), Vacutest® (95% CI -1.91 to -0.49) and Vacuette® (95% CI 0.10-1.84) tubes and for aPTT in Vacuette® (95% CI 0.22-2.00) and V-TUBE™ (95% CI -2.88 to -0.44). Unacceptable %bias was seen for aPTT in Vacucare (95% CI 2.78-4.59) and Vacutest® tubes (95% CI 2.53-3.82; desirable ±2.30), and in V-TUBE™ for mean cell volume (95% CI 1.15-1.47, desirable ±0.95%) and mean cell haemoglobin concentration (95% CI -1.65 to -0.93, desirable ±0.43%).
Blood collection tubes introduce variability to routine haematology results. We recommend that laboratories use one brand of tube. Verification of new candidate tubes should be performed to ensure consistency and reliable reporting of results.
临床实验室对血液采集管的验证至关重要。本研究旨在评估在即将发生的血液采集管全球短缺期间，来自四个替代供应商的候选管在常规诊断血液学检测中的性能。
在南非开普敦进行了一项多中心验证研究。从 300 名健康志愿者中采集血液，分别装入 BD Vacutainer® 比较管的 K EDTA 和柠檬酸钠管以及四种候选管（Vacucare、Vacuette®、V-TUBE™ 和 Vacutest®）中。进行了技术验证，包括管的物理性质和安全性。为了临床验证，进行了常规血液学检测。
Vacucare 管没有标线指示，Vacuette®管在静脉切开后帽外有血液污染，Vacutest®管有硬橡胶塞。Vacuette®、Vacucare 和 Vacutest®的 K EDTA 管与比较管的性能相似。在 Vacucare（95%CI-2.38 至-0.10）、Vacutest®（95%CI-1.91 至-0.49）和 Vacuette®（95%CI0.10-1.84）管中观察到 PT 持续偏倚不可接受，在 Vacuette®（95%CI0.22-2.00）和 V-TUBE™（95%CI-2.88 至-0.44）管中观察到 aPTT 不可接受的持续偏倚。在 Vacucare（95%CI2.78-4.59）和 Vacutest®管（95%CI2.53-3.82；理想值为±2.30）中观察到 aPTT 的不可接受的百分比偏倚，在 V-TUBE™中观察到平均细胞体积（95%CI1.15-1.47，理想值为±0.95%）和平均细胞血红蛋白浓度（95%CI-1.65 至-0.93，理想值为±0.43%）的不可接受的百分比偏倚。
血液采集管会给常规血液学结果带来变异性。我们建议实验室使用一种品牌的管。应验证新的候选管，以确保结果的一致性和可靠报告。
