YY/T 1182-2020 Translated English of Chinese Standard. (YYT 1182-2020, YY/T1182-2020, YYT1182-2020): Nucleic acids amplification test reagents (kits)https://www.chinesestandard.net, 22. maj 2020 - 16 sider This Standard specifies the terms and definitions, classification technical requirements, test methods, labels and instructions, packaging, transportation and storage of nucleic acids amplification test reagents (kits). This Standard applies to the quality control of nucleic acids amplification test reagents (kits). Nucleic acids amplification methods include polymerase chain reaction (PCR) technology and isothermal nucleic acid amplification technology. |
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5.3 Requirements 5.3.1 Positive reference absolute deviation acid extraction function acids amplification test amplification process amplification test reagents applicable certain number certified reference material coefficient of variation concentration log value corresponding requirements Ct value Delete detection limit reference detection range detection result document enterprise reference following methods GB/T gene linear correlation coefficient linear range Linearity of series Linearity of standard manufacturer shall specify meet the corresponding meet the requirements Modify national reference Negative reference conformance nucleic acid extraction nucleic acids amplification perform a detection Perform a determination period for testing Polymerase chain reaction Positive reference conformance positive sample quantitative reagents reference conformance rate reference or enterprise reference shall include Requirements for qualitative result shall meet select products selected for verification series diluted samples Stability The following take samples technical requirements Terms and definitions test method test reagents kits test result theoretical concentration Thermal stability test traceability variation CV