05/06/2026
Orient Gene's Hantavirus IgM Antibody Detection Kit Received Certification in China and the EU!
Recently, the Hantavirus IgM Antibody Detection Kit (Colloidal Gold Method) developed by Beijing Bioneovan Co., Ltd a controlled subsidiary of Orient Gene, has obtained the renewal of its medical device registration certificate in China. Additionally, the company's partner has recently completed product registration in Spain, allowing the kit to be sold in the EU and other countries recognizing EU certification. Currently, small orders from EU customers have been shipped in batches.
This kit is primarily used for antibody detection of hantavirus infection, supporting the establishment of early diagnosis and treatment systems for this infectious disease.
From a technical perspective, when used correctly, the kit provides qualitative test results within 15–20 minutes, saving valuable clinical treatment time. The detection antigen uses the conserved NP protein (immunodominant antigen) of hantavirus, ensuring high coverage of both New World and Old World hantaviruses. The kit is compatible with multiple sample types, including whole blood, serum, and plasma, making it suitable for various application scenarios. The testing procedure is simple and requires no specialized equipment; it can be performed in a standard laboratory, and trained professionals can carry out the test after basic training.
In terms of detection performance, the kit exhibits high sensitivity and no hook effect, meaning that false negatives are unlikely even in samples with high concentrations of strongly positive antibodies. Common interfering substances, such as IgM antibodies of other viruses and high concentrations of IgG, do not significantly affect the interpretation of test results.
In clinical applications, this kit is a rapid immunochromatographic assay intended for the qualitative detection of hantavirus IgM antibodies in whole blood, serum, or plasma. It is primarily used for early differential diagnosis of related antibodies, aiding in the rapid identification of hantavirus infection, including hemorrhagic fever with renal syndrome (HFRS). It is indicated for individuals presenting clinical signs and symptoms consistent with the disease and is for professional in vitro diagnostic use only.
On May 19 local time, WHO Director-General Dr. Tedros Adhanom Ghebreyesus stated that WHO assesses the global risk of hantavirus as still low. To date, 11 cases have been reported globally, including 3 deaths. Since the outbreak was first reported on May 2, no new deaths have occurred. Dr. Tedros noted that currently there is no indication of a larger-scale outbreak; however, the situation may still evolve, and WHO urges all affected countries to continue close monitoring.
