Standard Number: YY/T 1259-2015(YY/T1259-2015)
Chinese:戊型肝炎病毒IgG抗体检测试剂盒（酶联免疫吸附法）
English:Diagnostic kit for IgG antibody to hepatitis E virus(ELISA)
Effective Date:2016-01-01
ICS:11.000
Standard Applicability:This standard applies to the application of the principle of indirect enzyme-linked immunosorbent assay (ELISA), the use of hepatitis E virus (HEV) antigen-encapsulated microtiter plate and enzyme-labeled anti-human IgG and other reagents composed of the kit for the detection of hepatitis E virus IgG antibody in human serum or plasma samples. This standard specifies the terminology, definitions, classification, test methods, marking, labeling, instructions for use, packaging, transportation and storage requirements for Hepatitis E Virus IgG Antibody Detection Kit (enzyme-linked immunosorbent assay).
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