1    Scope
This standard specifies the terminology and definitions, evaluation requirements, evaluation indicators and evaluation methods for the quality evaluation of nucleic acid testing reagent.
This standard applies to nucleic acid test kit products and services.
This standard does not apply to nucleic acid test kits for high-throughput sequencing.

2    Normative references
The following documents are essential for the application of this document. For dated reference documents, only the dated version applies to this document. For reference documents without date, the latest version (including all amendments) applies to this document.
GB/T 21415    In vitro diagnostic medical devices　 Measurement of the amount of biological samples　 Metrology traceability of calibrator and control substance assignment
GB/T 37868    Technical specification for traceability of nucleic acid test kit