BioPerfectus is based in Taizhou, Jiangsu. [Photo/WeChat account: Taizhou Daily]
BioPerfectus, a leading biotech firm in Taizhou, Jiangsu, has achieved a major milestone, with its independently developed Dengue Virus NS1 Antigen and IgG/IgM Antibody Combo Test Kit (colloidal gold method) receiving approval from the World Health Organization's Expert Review Panel for Diagnostics.
The approval is a recognition of the product's quality, safety, and efficacy, allowing for emergency procurement by international agencies and national governments during major outbreaks. Globally, only five organizations have had seven products approved through this evaluation, with BioPerfectus being the first from China.
The kit offers can be used in a wide range of real-world scenarios and requires no specialized instruments, making it particularly suitable for use in resource-limited and remote areas. It simultaneously detects three dengue biomarkers, significantly improving detection accuracy and enabling faster diagnosis and treatment. Furthermore, the kit is effective across the entire course of the disease, from acute to recovery phases, offering strong clinical decision-making support.
"As the first Chinese company to receive WHO-ERPD recognition for dengue diagnostics, we are committed to swiftly responding to public health needs," said Zhou Guohui, vice-president of BioPerfectus. "We aim to accelerate the global deployment of our dengue detection solution, especially in high-incidence regions like Southeast Asia, Latin America, and Africa, and to share the benefits of Chinese innovation with the world."
Dengue fever is an acute viral disease transmitted by Aedes mosquitoes and is prevalent in over 100 tropical and subtropical countries. It can impact multiple bodily systems, including the circulatory and nervous systems, and may cause liver damage. Severe cases can be life-threatening. According to WHO, more than 14 million dengue cases were reported globally in 2024, doubling the number from the previous year.