YY/T 1182-2020: Translated English of Chinese Standard. (YYT 1182-2020, YY/T1182-2020, YYT1182-2020): Nucleic acids amplification test reagents (kits) [Tips: BUY here & GET online-reading at GOOGLE. Then, if you need unprotected-PDF for offline-reading, WRITE to Wayne: Sales@ChineseStandard.net]
https://www.chinesestandard.net, 22. mai 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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absolute deviation acid extraction function acids amplification test amplification test reagents Appearance applicable calculate classification coefficient of variation components contain corresponding requirements cycle Delete derivation detection limit reference detection result document enterprise reference example factors fluorescence following methods Formula GB/T gene genotypes instructions Internal standard labels linear range Linearity of series manufacturer shall specify measurement meet the corresponding meet the requirements Modify month national reference Negative reference conformance Note nucleic acid extraction nucleic acids amplification Operate according packaging perform a detection perform determination period for testing Positive reference conformance Precision qualitative reagents quantitative reference conformance rate reference material reference or enterprise relevant result shall meet select products series diluted samples setting similar System take samples technical requirements Technology Terms and definitions test method test reagents kits test result Thermal stability test threshold traceability validity period variation CV verify vitro diagnostic