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Great News| ZBI’s rapid antigen test obtained CE marked

Release Date:2022-11-08


On June 10th, ZBI’s Influenza A/B and RSV Antigen Test Kit (Colloidal Gold Immunochromatography Assay) obtained CE marked, which is a signal that our antigen detection kit allowed to sale within the Europe countries. Recently, ZBI has more than 10 CE marked products includes respiratory infections and Genitourinary Tract infections.

 

The antigen test kit detects three pathogens in one tube, includes Flu A, Flu B, and RSV. It only three steps and takes 15min to get test results.

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Respiratory Infectious significantly harm human, especially in children

       Globally, Influenza virus (IFV) and Respiratory Syncytial Viral (RSV) are common pathogens that caused respiratory infections. According to Andrea et al. (2017), compares to other lower respiratory pathogens, IFV (74.9%) and RSV (17.9%) has a higher rate to be detected [1]. WHO (2021) reported around 65 million people death during the flu seasons. A new study published in The Lancet estimates that acute lower respiratory infections caused by RSV killed more than 100,000 children under 5 years of age globally in 2019 [3]. Both RSV and IFV are prone to seasonal outbreaks in winter, and their symptoms of infection are similar, mainly acute fever, with non-specific symptoms including headache, pharyngitis and cough [4]. A study in Chinese Journal of Practical Pediatrics showed that RSV and IFV were the main pathogens of acute lower respiratory tract infection in children over 5 years old [5]. Mixed infection with multiple viruses may affect the clinical course of children, so attention should be paid to mixed infection during RSV infection [6].

 

 



 

REFERENCES

[1] Andrea H L Bruning, Mariska M G Leeflang, Johanna M B W Vos, Rene Spijker, Menno D de Jong, Katja C Wolthers, Dasja Pajkrt, Rapid Tests for Influenza, Respiratory Syncytial Virus, and Other Respiratory Viruses: A Systematic Review and Meta-analysis, Clinical Infectious Diseases, Volume 65, Issue 6, 15 September 2017, Pages 1026–1032, https://doi.org/10.1093/cid/cix461

[2] World Health Organization. Fact sheeton influenza(seasonal). In. [http://www.who.int/en/news-room/fact-sheets/detail/influenza-(seasonal)].

[3]20195岁以下儿童呼吸道合胞病毒引起的急性下呼吸道感染的全球、区域和国家疾病负担估计:系统分析, The Lancet  [https://www.ebiotrade.com/newsf/2022-5/20220520092546445.htm]

[4] Luc Bissonnette, Michel G. Bergeron. (2017) Portable devices and mobile instruments for infectious diseases point-of-care testing. Expert Review of Molecular Diagnostics 17:5, pages 471-494.

[5] 儿童急性下呼吸道感染病毒病原学研究--《中国实用儿科杂志》2009年第4 [http://www.cqvip.com/qk/91487a/200904/30050094.html]

[6] 儿童急性下呼吸道合胞病毒单一感染与混合感染对照研究《中国实用儿科杂志》201511 [https://www.cnki.com.cn/Article/CJFDTotal-ZSEK201511013.htm]


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