Standard Number: YY/T 1836-2021(YY/T1836-2021)
Chinese:呼吸道病毒多重核酸检测试剂盒
English:Multiple respiratory viral nucleic acids detection kit
Effective Date:2022-12-01
ICS:11.100.10
Standard Applicability:This standard specifies the requirements, test methods, labeling and instructions for use, packaging, transportation and storage of Respiratory Virus Multiplex Nucleic Acid Test Kit (hereinafter referred to as the kit). This standard applies to the quality control of respiratory virus multiple nucleic acid test kit, the kit is applicable to the type of samples including, but not limited to: nasopharyngeal swab, nasal swab, pharyngeal swab, alveolar lavage, sputum or other respiratory secretions; applicable respiratory viruses to be detected, including, but not limited to: Influenza A virus (Influenza A, IFV A), Influenza B virus ( Influenza A (IFV A), Influenza B (IFV B), Respiratory Syncytial Virus (RSV), Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV), Adenovirus (Adv), and other respiratory secretions. Adenovirus (Adv), Enterovirus (EV/Rhinovirus, RhV), Coronavirus (CoV); Applicable assays include, but are not limited to: fluorescent PCR, liquid/solid phase microarray, PCR melting curve, isothermal amplification, PCR capillary electrophoresis fragment analysis and second-generation sequencing technology.
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