Performance evaluation of the monkeypox virus nucleic acid detection kit by Jin Hao Pharmaceutical conducted by the National Institute for Viral Disease Control and Prevention, China CDC
Release time：2022.10.28
Recently, the Institute for Viral Disease Control and Prevention of the Chinese Center for Disease Control and Prevention conducted a product performance evaluation of the monkeypox virus nucleic acid detection kit (fluorescent PCR method) produced by Beijing Jinhao Pharmaceutical Co., Ltd., with excellent test results.
Supporting the rapid detection of the first confirmed case in the mainland
Monkeypox is a zoonotic infectious disease caused by the monkeypox virus, mainly characterized by fever, severe headache, lymphadenopathy, rash, and other symptoms. The principle of monkeypox prevention and control is early detection, early reporting, early isolation, early diagnosis, and early treatment. Currently, there are no specific antiviral drugs; treatment mainly involves symptomatic and supportive care. On July 23, 2022, the World Health Organization declared the monkeypox outbreak a "Public Health Emergency of International Concern."
On September 16, Chongqing City confirmed one imported monkeypox case, marking the first monkeypox case detected in mainland China since the outbreak began. An article published in the International Journal of Virology titled "Epidemiological Investigation and Handling of the First Confirmed Monkeypox Case in Mainland China" revealed the laboratory testing process of the first confirmed monkeypox case in the mainland:
On September 14, oropharyngeal and nasopharyngeal swab mixed samples and blister fluid from the case were collected at a centralized quarantine site and sent to the Chongqing Center for Disease Control and Prevention and the local CDC for laboratory testing. According to the local CDC laboratory results, the nucleic acid results of the oropharyngeal and nasopharyngeal swab mixed samples (Ct value: 31.37, Zhuocheng Huisheng) and blister fluid (Ct value: 31.64, Zhuocheng Huisheng) were both positive for monkeypox virus.
On the same day, oropharyngeal and nasopharyngeal swab mixed samples, blister fluid, and blood were collected again and sent to the Chongqing CDC laboratory for testing. The initial screening nucleic acid results of the oropharyngeal and nasopharyngeal swab mixed samples (Ct values: 23.33, Bojie; 21.79, Jinhao) and blister fluid (Ct values: 26.63, Bojie; 24.82, Jinhao) were all positive for monkeypox virus. Positive specimens were sent to the Chinese Center for Disease Control and Prevention for re-examination.
On September 16, after re-examination by the Chinese Center for Disease Control and Prevention, the samples were confirmed positive for monkeypox virus nucleic acid. Through gene sequencing, the Chongqing CDC confirmed that the monkeypox virus belongs to the West African B.1 branch.
Monkeypox virus nucleic acid reagent has passed EU CE certification
Jinhao Pharmaceutical's monkeypox virus nucleic acid detection kit (fluorescent PCR method) obtained EU CE certification on May 25 this year. As a professional in vitro diagnostic reagent (IVD) research and manufacturing company, we have rapidly responded in monkeypox virus nucleic acid detection based on our experience in developing and mass-producing diagnostic technology platforms for novel coronavirus and various infectious disease pathogens, strongly supporting the rapid detection of monkeypox virus.
When using the monkeypox virus nucleic acid detection kit, it can be paired with a handheld PCR analyzer independently developed by Jinhao Pharmaceutical. This real-time fluorescent quantitative PCR instrument recently received the Class III medical device product registration certificate (National Medical Device Registration No. 20223221369) from the National Medical Products Administration (NMPA). The instrument requires no calibration, is suitable for various scenarios, and offers fast detection, delivering results within half an hour.
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