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
https://www.chinesestandard.net, 8 déc. 2014 - 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.
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According to different after-sales service organization antigen CA19-9 quantitative Beijing CA19-9 quantitative detection CA19-9 reagent carbohydrate antigen CA19-9 chemiluminescent immunoassay reagent China Clinical Laboratory China SAC/TC 136 Coefficient of variation concentrations of 40±8 correlation coefficient device registration certificate following contents GB/T greater than 15 Instructions of reagent instrument-automatic operation least the following linear range manufacturer or after-sales materials or national 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