T/GDMDMA 0002-2021 Active Group standards

T/GDMDMA 0002-2021 Respiratory virus nucleic acid detection quality control material general technical requirements

Publish Date: 2021-05-25 Implement Date: 2021-05-25 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/GDMDMA 0002-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Animal quarantine, veterinary medicine, and disease prevention and control

ICS Name: Laboratory medicine

Publish Date: 2021-05-25

Implement Date: 2021-05-25

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.