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Efficiency and Health Economic Evaluations of BD OneFlow™ Flow Cytometry Reagents for Diagnosing Chronic Lymphoid Leukemia.
Cytometry Part B: Clinical Cytometry ( IF 3.4 ) Pub Date : 2019-04-02 , DOI: 10.1002/cyto.b.21779
Eoin Moloney 1 , Helen Watson 2 , Dawn Barge 2 , A Joy Allen 3 , Peter Carey 4 , Jennifer Hislop 5 , Louise Johnston 6 , Kate Lorrison 2 , Andrew McGregor 4 , Rachel A O'Leary 7 , Michael H Power 7 , Jonathan Wallis 2 , A John Simpson 3 , Brigit Greystoke 4
Affiliation  

REASON FOR THE STUDY To standardize the use of flow cytometry for classifying hematological malignancies and make the results reliable and reproducible across laboratories, the EuroFlow™ Consortium published a comprehensive specification of antibody-fluorochrome conjugates, standard protocols, and algorithms for analysis. The BD OneFlow™ system builds on, and further standardizes, the EuroFlow protocols. We aimed to assess the effects on safety, efficiency, and costs for laboratories of adopting the BD OneFlow reagent tubes (LST and B-CLPD T1) for diagnosing chronic lymphocytic leukemia. METHODS We compared in-house laboratory processes and results with those using the LST and B-CLPD T1 reagent tubes with, and without, blood film morphology. Outcome measures included concordance in classification results, and efficiency within the laboratory, that is, resource usage, staff time, unwanted events, and cost-consequences. RESULTS There was 100% concordance between the classifications made with in-house flow cytometry and those with the BD OneFlow reagent tubes. Using BD OneFlow tubes required 13 hours less staff time per month (i.e. for 100 samples) than the in-house process. Sensitivity analyses explored the effects of uncertainties in the price of the BD OneFlow tubes and the prevalence of CLL and identified the thresholds at which laboratories might expect cost-savings from adopting the BD OneFlow system. Laboratory and clinical staff considered the BD OneFlow system to be safe and effective. CONCLUSIONS Laboratories adopting the BD OneFlow system for classifying patients with suspected CLL can expect safe, efficient processes that can be cost saving if the discount on the list price, and prevalence of CLL (which will both vary between sites and countries), is within the thresholds suggested by the health economics sensitivity analysis. © 2019 International Clinical Cytometry Society.

中文翻译:

BD OneFlow™流式细胞仪试剂用于诊断慢性淋巴白血病的效率和健康经济性评估。

研究原因为了标准化流式细胞仪对血液系统恶性肿瘤的分类,并使结果在实验室之间可靠和可重复,EuroFlow™联盟发布了抗体-荧光染料结合物,分析方法和算法的全面规范。BD OneFlow™系统建立在EuroFlow协议之上,并进一步对其进行了标准化。我们旨在评估采用BD OneFlow试剂管(LST和B-CLPD T1)诊断慢性淋巴细胞性白血病对实验室的安全性,效率和成本的影响。方法我们将内部实验室过程和结果与使用有无血膜形态的LST和B-CLPD T1试剂管的结果进行了比较。结果指标包括分类结果的一致性,以及实验室内的效率,即资源使用,员工时间,不需要的事件和成本后果。结果内部流式细胞仪和BD OneFlow试剂管的分类之间有100%的一致性。与内部过程相比,使用BD OneFlow试管每月需要的工作时间减少了13个小时(即100个样品)。敏感性分析探讨了BD OneFlow管价格不确定性和CLL患病率的影响,并确定了实验室期望采用BD OneFlow系统可节省成本的门槛。实验室和临床人员认为BD OneFlow系统是安全有效的。结论采用BD OneFlow系统对可疑CLL患者进行分类的实验室可以期望安全,有效的流程,如果在标价上打折,和CLL的患病率(因地点和国家而异)在健康经济学敏感性分析所建议的阈值之内。©2019国际临床细胞计量学会。
更新日期:2019-04-02
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