T/GDMDMA 0001-2021 Active Group standards

T/GDMDMA 0001-2021 Respiratory Pathogen Multiplex Nucleic Acid Detection Kit (Fluorescent PCR Method)

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 0001-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Chemical reagents

ICS Name: Laboratory medicine

Publish Date: 2021-05-25

Implement Date: 2021-05-25

Scope

Scope: This document specifies the requirements, test methods, labels and user manuals, packaging, transportation, and storage for multiplex nucleic acid detection kits for respiratory pathogens (hereinafter referred to as "kits"). This document applies to the quality control of multiplex nucleic acid detection kits for respiratory pathogens. The types of samples applicable to the kits include nasopharyngeal swabs, nasal swabs, pharyngeal swabs, alveolar lavage fluid, sputum, or other respiratory secretions; the applicable respiratory pathogens include respiratory viruses, bacteria, mycoplasmas, and chlamydia. Among them, respiratory viruses include influenza A virus (IFV A), influenza B virus (IFV B), respiratory syncytial virus (RSV), adenovirus (Adv), and SARS-CoV-2, etc.; respiratory infection bacteria include Streptococcus pneumoniae (SP), Legionella pneumophila (LP), and Haemophilus influenzae (HI), etc.; respiratory infection mycoplasmas include Mycoplasma pneumonia (MP), etc.; and respiratory infection chlamydia include Chlamydia pneumonia (CP), etc. The kits are applicable to the qualitative detection of respiratory pathogen nucleic acids in human samples using fluorescent probe real-time PCR, with the target being the specific gene sequences of respiratory pathogens, and are used clinically to assist in the diagnosis of diseases related to respiratory pathogen infections. Main technical content: appearance, internal standard and/or control, accuracy, specificity, detection limit, precision, stability.