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Hybribio COVID-19 Real-Time PCR Kit is included in the WHO Emergency Use List

2020-06-18 15:22:06 凱普生物 258

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On June 15, the COVID-19 Real-Time PCR Kit (fluorescent PCR method) developed by Hybribio was officially included in the World Health Organization (WHO) Emergency Use Listing (EUL).

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In response to the need for the prevention and control of the novel coronavirus epidemic, on February 28, WHO announced the launch of the EUL of the novel coronavirus detection reagent. EUL is a mechanism for WHO pre-qualification to respond to emergency public health conditions. Products that have obtained the WHO emergency approval will be included in the WHO product list to provide procurement basis for WHO member countries and buyers in need. WHO approved all the materials (including quality management system, R&D documents, clinical verification reports, etc.) submitted by Hybribio.

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Thanks to Hybribio' s research and development capabilities and accumulated technical experience, the research and development of Hybribio COVID-19 Real-Time PCR Kit (fluorescent PCR method) was quickly completed after the sequence of the virus was released.  This kit has obtained EU CE, Brazil ANVISA and national certifications of countries, such as Peru and Mexico, and various countries set a high value on the performance of the kit. The kit has high sensitivity and specificity, being highly recognized by international professional research institutions. The external quality assessment of novel coronavirus nucleus acid testing laboratories conducted by the National Health and Safety Commission Clinical Inspection Center showed that the positive and negative results judged using the kit were in full compliance with the nature of the samples tested. WHO’s approval is the recognition and affirmation of Hybribio's product quality and R&D capabilities.

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Although the current epidemic situation in Europe is getting better, the situations in Russia, the United States, the Middle East, and Africa are still not very optimistic. With the mission of serving human health, Hybribio has been actively invested in this global war against the epidemic, exerting its professional advantages and providing reliable and accurate clinical testing support for the prevention and control of both domestic and oversea epidemic.