血清学实验室技术管理方案的提出

W. H. Veneziano, E. A. Oliveira
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引用次数: 0

摘要

在这项工作中,我们制定了一项拟议的血液中心血清学实验室管理技术计划,解决了体外诊断设备的鉴定和验收测试过程。我们解决了设备的特点,并与几个临床研究中使用的诊断试剂盒的关系。我们在巴西血库进行了这项研究,涉及血清学检测所用诊断试剂盒的接收、处理和储存条件。该调查还研究了血液中心供应商的诊断试剂盒的分销部门。为了纠正血库中发现的问题,并作为其他血液中心的灯塔,我们研究了法律和设备,并在实验室血清学中制定了技术部署脚本,从临床工程的角度解决了预安装,安装,验收测试和验证过程,寻求血清学筛选过程结果的最大可靠性,以避免错误的结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Proposal of a plan of technology management for serology laboratories
In this work we developed a proposed plan of management technology for serology laboratory of blood centers, addressing the processes of qualification and acceptance testing of equipment for in vitro diagnostics. We addressed the characteristics of equipment and made the relationship with the diagnostic kits used in several clinical researches. We conducted this research in a Brazilian blood bank, with respect to conditions of receiving, handling and storage of diagnostic kits used for serologic tests. The survey also looked at the distribution sector of the diagnostic kits of the company supplier of blood center. As a suggestion to correct problems identified in blood bank and also to serve as a beacon for other blood centers were studied laws and also equipment, and we produced a script deployment of technology within a laboratory serology, addressing the pre-installation, installation, acceptance testing and validation process from the point of view of clinical engineering, seeking maximum reliability of the outcome of the screening process serological to avoid erroneous results.
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