YY/T 1176-2010 Translated English of Chinese Standard. (YYT 1176-2010, YY/T1176-2010, YYT1176-2010): Cancer antigen CA 15-3 quantitative detection reagent (kit) - Chemiluminescent immunoassayhttps://www.chinesestandard.net, 8 ธ.ค. 2014 - 12 หน้า This standard specifies the classification, requirements, test method, identification, labels, instructions, packaging, transportation and storage of the cancer antigen CA15-3 quantitative detection reagent (kit) (chemiluminescent immunoassay). This standard is applicable to test cancer antigen CA15-3 reagent (kit), based on the principles of chemiluminescent immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) with carriers of microwell plates, tubes, magnetic particles, micro-beads and plastic-beads. The Standard is not applicable to: a) The tumor marker calibrators and tumor marker control materials that are intended for separate sales. b) Biochip that uses the principle of chemiluminescent immunoassay. |
คำและวลีที่พบบ่อย
30-times measurement results According to different after-sales service organization antigen CA15-3 quantitative Beijing CA15-3 quantitative detection CA15-3 reagent CA15-3 reagent kit Calculate the mean cancer antigen CA15-3 chemiluminescent immunoassay reagent China Coefficient of variation concentrations of 30±6 correlation coefficient CV is obtained detect in accordance device registration certificate Expiration date GB/T Instructions of reagent instrument-automatic operation international reference materials linear range linearity and repeatability manufacturer or after-sales materials or national mean value Medical device registration micro-beads and plastic-beads minimum detection limit national standard products non-enzymatic chemiluminescent immunoassay obtained and based 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 sample to perform Stability The following Storage conditions Test methods Thermal stability test Traceability tumor marker U/mL validity variation CV Within-batch difference zero-concentration calibrator