HymonBio Receives EU CE for Two COVID-19 Products


HymonBio Receives EU CE for Two COVID-19 Products

HymonBio focuses on the development of precision medical industry and POCT-related products, and actively responds to domestic and international market demand, taking on social responsibilities. The research-and-development team has been continuously expanding their COVID-19 product line, and has contributed to the fight against the epidemic. Now, two more products have received CE certification.

The Hymon® COVID-19 Antigen Rapid Test Kit and Hymon® Respiratory Triplex Panel Test Kit complied with the requirements of the EU directive and have registered with the proper authorities. This is a new product expansion after obtaining the US FDA EUA and EU CE for the Hymon® SARS-CoV-2 Test Kit.

There are many similarities in the epidemiology and clinical symptoms of SARS-CoV-2, influenza A and influenza B. Timely differential diagnosis can achieve appropriate management and take targeted preventative and treatment measures. Guidelines, such as China’s “Influenza Diagnosis and Treatment Plan” (2019 edition) and the “State Council’s Response to Novel Coronavirus Pneumonia Diagnosis and Treatment Plan” (8th edition) explicitly stressed the importance of virus identification, scientific management, and precise diagnosis and treatment.

The US FDA guidelines for detection of COVID-19 and respiratory syncytial viruses refer to the molecular testing. Patients infected with these viruses share similar clinical symptoms, but treatment and management for each are vastly different. Especially during the flu season, it is necessary to distinguish COVID-19 from influenza or other viral infections before treatment. Therefore, it is particularly critical to detect and identify a variety of viruses quickly and accurately. With the COVID-19 epidemic at an important stage of prevention and control, timely and accurate diagnosis can effectively control its spread.

The Hymon® Respiratory Triplex Panel Test Kit offers unique technical advantages:

Rapid detection: The innovative and exclusive one-step method completes nucleic acid processing of 3 pathogens in 2 minutes, with sample-to-results in 35 minutes.

One-step: One tube for multiple tests: SARS-CoV-2 N/E genes, influenza A, and influenza B.

Accurate and safe: Full gene coverage, multi-target detection, and multiple guarantees. Among which the COVID-19 detection has been approved by the FDA.

Multiple monitoring: Increase the operation process of human DNA gene sequence monitoring, and 3 quality controls: positive, negative, and human-derived internal standard controls.

Quality control: The unique nanobody molecular-locking (MoLock) technology improves sensitivity and specificity.

High sensitivity: As high as 5 copies / reaction.

HymonBio is rooted in China, and provides accurate and rich COVID-19 products for international epidemic prevention and control.

Post time: Feb-10-2022