弓形虫病间接荧光抗体商业试剂的上市前评估
Premarket evaluation of commercial toxoplasmosis indirect fluorescent-antibody reagents.
作者信息
Durham T M, Colvin H M
出版信息
J Clin Microbiol. 1978 Mar;7(3):255-60. doi: 10.1128/jcm.7.3.255-260.1978.
Abstract
The quality of commercial toxoplasmosis indirect fluorescent-antibody reagents was evaluated over a 6-year period. Seven manufacturers voluntarily submitted their products for evaluation in the Center for Disease Control Premarket Evaluation Program. Each product was tested in accordance with the Center for Disease Control performance and labeling specifications and evaluation methods. Only 49% of all of the products tested met the Center for Disease Control requirements. Performance criteria are outlined, and suggestions are offered to assist laboratorians in obtaining toxoplasmosis indirect fluorescent-antibody reagents of high quality.
摘要
在6年的时间里对商业性弓形虫病间接荧光抗体试剂的质量进行了评估。七家制造商自愿提交其产品参加疾病控制中心的上市前评估项目。每种产品都按照疾病控制中心的性能、标签规范及评估方法进行测试。所有测试产品中只有49%符合疾病控制中心的要求。文中概述了性能标准，并提出了一些建议以帮助实验室人员获得高质量的弓形虫病间接荧光抗体试剂。
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Premarket evaluation of commercial toxoplasmosis indirect fluorescent-antibody reagents.弓形虫病间接荧光抗体商业试剂的上市前评估
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