T/GDMDMA 0002-2021 Respiratory virus nucleic acid detection quality control material general technical requirements
T/GDMDMA 0002-2021 Respiratory virus nucleic acid detection quality control material general technical requirements
Basic Information
Scope
Scope: This standard specifies the general technical requirements, evaluation indicators, and evaluation methods for quality control materials used in the detection of respiratory viral nucleic acid. This standard applies to the performance evaluation of quality control materials for the detection of respiratory viral nucleic acid, including: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A virus (IVA), Influenza B virus (IVB), Respiratory Syncytial Virus, Adenovirus (ADV), Parainfluenza Virus, Human Coronavirus, etc. This standard does not apply to: a) Quality control materials for microbiological, immunohistochemical, molecular pathological, and morphological detection; b) Quality control materials for microorganisms of other pathogens other than respiratory viruses. Main technical content: Requirements for raw materials, packaging requirements, interchangeability and matrix effect requirements, uniformity requirements, stability requirements, traceability requirements, and attribute value assignment requirements.