T/SZAS 73-2023 Nuclease assay kit performance validation
T/SZAS 73-2023 Nuclease assay kit performance validation
Basic Information
Scope
Scope: This document specifies the classification, performance requirements, and validation methods for nucleic acid concentration detection reagents, as well as the validation rules for these reagents. This document is applicable to the performance validation of nucleic acid concentration detection kits, which can be used to quickly detect and obtain results from trace nucleic acid samples of double-stranded DNA or single-stranded DNA. This document is suitable for manufacturers of nucleic acid concentration detection reagents and various testing institutions that use these reagents to conduct related experiments. Main technical content: It standardizes the relevant terms and definitions for the performance validation of nucleic acid concentration detection kits; standardizes the classification of nucleic acid concentration detection kits; standardizes the performance requirements of nucleic acid concentration detection kits; standardizes the methods for the performance validation of nucleic acid concentration detection kits; and standardizes the rules for the performance validation and judgment of nucleic acid concentration detection kits.