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Gain Another Certification! Hybribio’s Overall Solution for COVID-19 Testing

2021-04-23 11:46:56 凱普生物 239

The large-scale global outbreak of the COVID-19 pandemic now tends to normalize. Nucleic acid testing has accurately and timely detected people infected with COVID-19, which plays a vital role in preventing the spread of the pandemic. As a high-quality supplier of IVD products, Hybribio has been fully committed to fighting the pandemic, continuously researching and developing, and providing a series of diagnostic products with strong specificity and high sensitivity for timely detection.

Hybribio’s Two New Testing Kits Certified!

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Hybribio independently developed COVID-19 Real-Time PCR Kit

Registration Certificate No.: 國械注準20213400269

 

Recently, Hybribio COVID-19 Real-Time PCR Kit was approved by the Nation Medical Product Administration and certified by the Therapeutic Goods Administration (TGA).

The Wuhan Institute of Virology of the Chinese Academy of Sciences, the Guangdong Provincial Center for Disease Control and Prevention, and the National Key Virus Research Institute of Shantou University and the University of Hong Kong conducted performance tests on Hybribio’s COVID-19 nucleic acid detection reagents, and the results of both positive and negative samples were consistent. The results of the National Laboratory Quality Evaluation Report of the National New Coronavirus Nucleic Acid Test conducted at the Clinical Laboratory Center of the National Health and Medical Commission showed that the accuracy of the positive and negative samples of Hybribio’s reagents was in full compliance.

In addition, our products have also obtained the CE certification of European Union and ANVISA certification of Brazil, and listed in World Health Organization Emergency Use List (WHO EUL). They have been exported to countries including Brazil, Mexico, Germany, Hungary, Spain, Denmark, Italy, Iran and so on, and their quality has been highly regarded by users.

 

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Hybribio Independently Developed SARS-CoV-2 Real-Time PCR Kit

In December 2020, the National Health Commission issued the "Workbook for Nucleic Acid Detection of New Coronavirus in Medical Institutions (Trial Second Edition)", suggesting the use of highly sensitive nucleic acid detection reagents (detection limit ≤ 500 copies/mL) to reduce the risk of missed detection that may be caused by insufficient reagent sensitivity or virus mutation..

After repeated sample tests and performance certification, Hybribio’s R&D team developed SARS-CoV-2 Real-Time PCR Kit, using ORF1ab gene, N gene and E gene as target genes, with high sensitivity and lowest detection limit of 200 copies/mL, reducing the risk of missed detection. Recently, the reagent has obtained CE certification of European Union, and can be put in o use in many places.

Hybribio’s Overall Solution for Covid-19 Testing

Early detection, early diagnosis, early quarantine and early treatment are effective means to control the spread of the pandemic. Hybribio has a mature industrialization platform and has formed an overall solution for COVID-19 testing in response to the needs of preventing and controlling the pandemic in different periods, providing more targeted, professional and authoritative options for the prevention and control of the pandemic, and making the detection of virus more accurate and more accurate, faster and safer.

——We sincerely invite global partners——

Email: isw@hybribio.cn

Tel: 0768-2852923 Ext.8193

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