抗链球菌溶血素O（ASO）检测试剂盒
1范围
标准规定了德国ProDia Diagnostics生产的抗链球菌溶血素O(ASO)检测试剂盒（胶乳增强免疫比浊法）的分类、要求、试验方法、标志、标签、使用说明书、包装、贮存和运输。
本标准适用于德国ProDia Diagnostics生产的抗链球菌溶血素O(ASO)检测试剂盒（胶乳增强免疫比浊法）（以下简称试剂盒），体外诊断试剂，用于检测人血清抗链球菌溶血素O(ASO)含量，可以应用于全自动生化分析仪和半自动生化分析仪。
下列文件中的条款通过本部分的引用而成为本部分的条款。凡是注日期的引用文件，其随后所有的修改单（不包括勘误的内容）或修订版均不适用于本部分，然而，鼓励根据本部分达成协议的各方研究是否可使用这些文件的{zx1}版本。凡是不注日期的引用文件，其{zx1}版本适用于本部分。
GB191-2008 包装储运图示标志
3分类
3.1 包装规格
R1：1×40ml
3.2 方法原理
胶乳增强免疫比浊法
将链球菌溶血素O包被在胶乳颗粒上，可与血清中的抗链球菌溶血素O产生凝集反应，形成抗原抗体复合物，通过测定570nm波长的吸光度值，其浊度高低与血清中抗链球菌溶血素O浓度成正比。
Antistreptolysin O (ASO) Detecting Kit
1 Scope
This standard specifies the classification, requirements, testing methods, marks, labels, instructions for use, package and shipment for Antistreptolysin O (ASO) Detecting Kit (Latex-Enhanced Immunoturbidimetry Test) manufactured by Germany ProDia Diagnostics.
Antistreptolysin O (ASO) Detecting Kit (Latex-Enhanced Immunoturbidimetry Test) (to be referred as testing kit) manufactured by Germany ProDia Diagnostics is in vitro biochemical testing kit for diagnosis, applicable to automatic and semi-automatic biochemical analyzer.
2 Regulatory reference documents
Provisions in following documents become the ones in this standard through quotation. All dated reference documents, as well as all revision sheets (corrected parts excluded) or revised versions do not apply to this standard, however, it is encouraged that all parts who have made an agreement discuss whether the latest versions of these documents can be used.
GB191-2008 Graphics and marks for package, storage, and shipment
3 Classification
3.1 Packing specifications
R1：1×40ml
3.2 Rationale for this method
Latex-Enhanced Immunoturbidimetry Test
Encoat latex particles with Antistreptolysin O which can react with anti-Antistreptolysin O in serum (that is agglutination) to form antigen-antibody complex. Determine the absorbance at the wavelength of 570nm, with the turbidity proportional to the anti-Antistreptolysin O concentration in serum.
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