Novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) - NMPA Registration 国械注准20223400504

This product is used for in vitro qualitative detection of novel coronavirus (2019-nCoV) nucleocapsid (N) antigen in nasal swab samples. Applicable groups shall refer to the "New Coronavirus Antigen Testing Application Plan (Trial)" and other relevant national regulations. This product cannot be used alone for the diagnosis of new coronavirus infection, a positive result only indicates that there may be a specific antigen of the new coronavirus in the sample, and the infection status should be judged in combination with the nucleic acid test results. A negative result does not exclude novel coronavirus infection and should not be used alone as a basis for making treatment and disease management decisions. Suspected patients with corresponding clinical symptoms should undergo further nucleic acid testing, regardless of whether the antigen test is positive or negative. Subjects who test positive should follow local epidemic prevention and control policies for reporting and isolation, and seek corresponding medical help; Subjects with negative tests should strictly abide by local epidemic prevention and control requirements, and use nucleic acid testing for confirmation if necessary. The product use environment should follow relevant national regulations such as the "New Coronavirus Antigen Testing Application Plan (Trial)".

本产品用于体外定性检测鼻拭子样本中新型冠状病毒（2019-nCoV）核衣壳（Nucleocapsid，N）抗原。适用人群参照《新冠病毒抗原检测应用方案（试行）》等国家相关规定执行。本产品不能单独用于新型冠状病毒感染的诊断，阳性结果仅表明样本中可能存在新型冠状病毒特定抗原，应结合核酸检测结果判断感染状态。阴性结果不能排除新型冠状病毒感染，也不得单独作为作出治疗和疾病管理决定的依据。有相应临床症状的疑似患者抗原检测不管是阳性还是阴性，均应进行进一步的核酸检测。检测阳性受试者应遵循当地疫情防控政策进行报告和隔离，并寻求相应的医疗帮助；检测阴性受试者应严格遵守当地疫情防控要求，必要时采用核酸检测进行确认。产品使用环境应遵循《新冠病毒抗原检测应用方案（试行）》等国家相关规定。