一种非凝胶机械分离血浆采集管在选定治疗药物检测中的多中心评估。
A Multicenter Evaluation of a Nongel Mechanical Separator Plasma Blood Collection Tube for Testing of Selected Therapeutic Drugs.
机构信息
BD, Franklin Lakes, NJ.
School of Medicine, University of Maryland, MD, USA.
出版信息
J Appl Lab Med. 2020 Jul 1;5(4):671-685. doi: 10.1093/jalm/jfaa033.
BACKGROUND
Some therapeutic drugs are unstable during sample storage in gel tubes. BD Vacutainer® Barricor™ Plasma Blood Collection Tube with nongel separator was compared with plasma gel tubes, BD Vacutainer PST™, PST II, and BD Vacutainer Serum Tube for acetaminophen, salicylate, digoxin, carbamazepine, phenytoin, valproic acid, and vancomycin during sample storage for up to 7 days.
METHODS
Seven hospital sites enrolled 705 participants who were taking at least one selected drug. The study tubes were collected and tested at initial time (0 h), after 48 h of storage at room temperature and on day 7 (after additional 5 days of refrigerated storage). The performance of BD Barricor tube was evaluated for each drug by comparing BD Barricor samples with samples from the other tubes at 0 h from the same participant; stability was evaluated by comparing test results from the same tube at 0 h, 48 h, and 7 days.
RESULTS
At 0 h, BD Barricor showed clinically equivalent results for selected therapeutic drugs compared with the other tubes, except phenytoin in BD PST. Phenytoin samples ≥20 µg/mL in BD PST had 10-12% lower values than samples in BD Barricor. During sample storage, all selected drugs remained stable for 7 days in BD Barricor and in serum aliquots. In BD PST, all drugs remained stable except phenytoin and carbamazepine and in BD PST II except for phenytoin.
CONCLUSION
The BD Barricor Tube is effective for the collection and storage of plasma blood samples for therapeutic drug monitoring without sample aliquoting.
背景
一些治疗药物在凝胶管中样品储存时不稳定。BD Vacutainer® Barricor™ 无凝胶分离血浆采集管与血浆凝胶管、BD Vacutainer PST™、PST II 和 BD Vacutainer 血清管进行了比较，用于在室温下储存长达 7 天的对乙酰氨基酚、水杨酸盐、地高辛、卡马西平、苯妥英、丙戊酸和万古霉素的样品。
方法
7 个医院站点招募了 705 名正在服用至少一种选定药物的参与者。在初始时间（0 h）、室温下储存 48 h 后以及第 7 天（额外 5 天冷藏储存后）收集和测试研究管。通过将 BD Barricor 管与同一参与者的其他管的 0 h 时的样本进行比较，评估 BD Barricor 管对每种药物的性能；通过比较同一管在 0 h、48 h 和 7 d 时的测试结果，评估稳定性。
结果
在 0 h 时，BD Barricor 对所选治疗药物的检测结果与其他管相当，除了 BD PST 中的苯妥英。BD PST 中≥20μg/ml 的苯妥英样本值比 BD Barricor 中的样本值低 10-12%。在样品储存过程中，所有选定的药物在 BD Barricor 和血清等分试样中在 7 天内保持稳定。在 BD PST 中，除了苯妥英和卡马西平以及 BD PST II 中的苯妥英外，所有药物均保持稳定。
结论
BD Barricor 管可有效收集和储存治疗药物监测的血浆血样，无需样品等分。
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