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Neihu, Taiwan (March 16, 2020)
Abnova announced today the it has partnered with Labospace Srl for COVID-19 serum antibody rapid test clinical study in Italy. Abnova has quickly adopted its COVID-19 serum IgM/IgG test from ELISA to the lateral flow strip-based platform for rapid point-of-care (POC) testing. Abnova and Labospace Srl will work together to sponsor a fast-track clinical trial in Italy aiming for CE-IVD certification. The CE-IVD will provide the quality assurance that a rapid test can be commercialized throughout the European market. Due to the escalating outbreak in Italy and European countries, patient recruitment and sample collection will be much faster in Italy than in Taiwan.
Serum IgM/IgG antibody immune response is excellent indicator of recent exposure and infection from COVID-19 coronavirus. Abnova’s serum IgM/IgG ELISA test can be used to screen and confirm infected individuals, not only to control further spread of transmission but also provide an evidence of antibody reactivity demonstrating protection and preventing re-infection. The current COVID-19 testing requires the use of RT-PCR to identify genes in the viral genome as an evidence of infection. Abnova’s serum IgM/IgG ELISA test can complement the current RT-PCR test, especially for patients who have tested negative on RT-PCR before performing the arduous CT scan.
Abnova is simultaneously working on a lateral flow rapid test for COVID-19 coronavirus. COVID-19 spike protein is distributed throughout the surface of the coronavirus. Unlike the NP protein which is located inside the virus, there are more abundant spike protein on the viral surface which can be detected by an antibody to achieve higher detection sensitivity. Abnova has applied its DNAx™ Immune technology for the production of the highly specific antibody which will be available in early April. This COVID-19 coronavirus rapid test will also be prioritized into a lateral flow rapid test format for clinical study. |
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Abnova has established a comprehensive portfolio of fully integrated solutions to address the needs of the in vitro diagnostic (IVD) industry. Abnova provides its partners and customers access to the technologies, products, and services relating to circulating rare cells, circulating exosomes, and circulating cell-free RNA for early to metastatic to recurrent disease and treatment diagnosis, prediction, guidance, and monitoring. Abnova facility is for proprietary bioreagent and high-throughput automation development and manufacturing for clinical trials and IVD commercialization. (www.abnova.com)