FDA Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi
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Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi[附网盘链接]由Food&Drug Administration于之前发布，适用于美国。标准截图
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标准文档类型为Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi Guidance for Industry and Food and Drug Administration Staff This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. Introduction FDA is issuing this guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of antibodies to Borrelia burgdorferi. These devices are used to aid in the diagnosis of Lyme disease. FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. Background This document recommends studies for establishing the performance characteristics of in vitro diagnostic devices for the detection of antibodies to B. burgdorferi in human serum, plasma, and blood. Serological testing for antibodies to B. burgdorferi in Lyme disease diagnostics is a two step procedure [Ref. 1, 2]. Initial testing is done by an enzyme immunoassay (EIA) or immunofluorescent assay (IFA); specimens yielding positive or equivocal results are tested further by using a Western immunoblot assay. Specimens negative by a sensitive EIA or IFA do not need further testing. Results from Western
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