YY/T 1192-2011: Translated English of Chinese Standard. (YYT 1192-2011, YY/T1192-2011, YYT1192-2011): Human chorionic gonadotropin (HCG) quantitative detection reagent (kit) (Chemiluminescent immunoassay)

This standard specifies the classification, requirements, test method, marks, labels, instructions, packaging, transportation and storage etc. of the human chorionic gonadotropin quantitative detection reagent (kit) (chemiluminescent immunoassay). This standard is applicable to the quantitative detection of human chorionic gonadotropin (HCG) reagent (kit) of the human blood matrix or other body fluid components, based on the principle of chemiluminescent immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) in the carrier of microplates, pipes, magnetic particles, microbeads and plastic beads. This standard does not apply to: a) The calibrators and quality-control materials of human chorionic gonadotropin that are intended for separate sale; b) The biochip that uses chemiluminescent immunoassayas the principle.