YY/T 1178-2010 Translated English of Chinese Standard. (YYT 1178-2010, YY/T1178-2010, YYT1178-2010): Carbohydrate antigen CA19-9 quantitative detection reagent(kit) - Chemiluminescent immunoassay [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]https://www.chinesestandard.net, 2014 M12 8 - 12 pages This standard specifies the classification, requirements, test method, identification, labels, instructions, packaging, transportation and storage of the carbohydrate antigen CA19-9 quantitative detection reagent (kit) (chemiluminescent immunoassay). This standard is applicable to test carbohydrate antigen (CA19-9) reagent (kit), based on the principles of chemiluminescent immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) with the carriers of microwell plates, tubes, magnetic particles, micro-beads and plastic beads. This standard is not applicable to: a) The tumor marker calibrators and tumor marker control materials are intended for separate sales; b) Biochip in the principle of chemiluminescent immunoassay. |
Common terms and phrases
According to different after-sales service organization antigen CA19-9 quantitative Beijing CA19-9 quantitative detection carbohydrate antigen CA19-9 chemiluminescent immunoassay reagent China Clinical Laboratory China SAC/TC 136 Coefficient of variation concentrations of 40±8 correlation coefficient detection reagent kit device registration certificate following contents GB/T greater than 15 Instructions of reagent instrument-automatic operation labels least the following linear range manufacturer or after-sales mean value measurement results Medical device registration micro-beads and plastic Minimum detectable concentration minimum detection limit national standard material non-enzymatic chemiluminescent immunoassay obtained and based package of reagent packaging specifications perform the detection principle of chemiluminescent Product batch number Product name Product standard number quantitative detection reagent recovery rate reference value registration certificate number relative deviation requirements of 4.3 result shall comply RLU value corresponding samples with concentrations standard deviation SD Storage conditions Thermal stability test Traceability tumor marker U/mL concentration deviation validity is placed variation CV Within-batch difference zero-concentration calibrator