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)
https://www.chinesestandard.net, 8 déc. 2014 - 12 pages
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.
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10-times measurement 10-times measurement results 30-times measurement results According to different according to Formula after-sales service organization allowable concentration deviation average value cM batch of reagent Beijing chemiluminescent immunoassay reagents coefficient of variation corresponding to cM+2SD detection result deviation is 20 following contents HCG reagent HCG sample containing human chorionic gonadotropin immunoassay reagents kits Instructions of reagent IU/L its allowable least the following linear range lower than 200 manual operation method manufacturers or after-sales manufacturing enterprise mean value Medical device registration meet the requirements minimum detection limit non-enzymatic chemiluminescent immunoassay package of reagent packaging specifications perform the detection principle of chemiluminescence Product name Product standard number quantitative detection reagent recovery rate registration certificate number relative deviation repeat the detection requirements in 4.3 Respectively repeat result shall comply RLU value corresponding standard deviation SD Storage conditions Thermal stability test three batch Traceability validity are placed variation CV according zero-concentration HCG sample