A Polish laboratory diagnostics company is attempting to register a rapid screening test which can detect signs of coronavirus within 10 minutes.
BioMaxima S.A. which is based in Lublin has applied to Poland’s Office for Registration of Medicinal Products to have the test, which is labelled 2019-nCoV Wuhan IgG/IgM and developed by China-based company Hangzou AllTest Biotech Co. Ltd., to be registered.
BioMaxima CEO Łukasz Urban told PAP that the test involves a rapid immunochromatographic procedure to detect the presence of IgG and IgM antibodies (coronavirus) in humans and does not require any specialised equipment.
He added that similar algorithms that distinguish ‘an ordinary’ influenza from that caused by COVID-19 are already being introduced in Germany, he added.
The testing kit consists of individually packed cassettes containing a sample tray in which the test material (whole blood, plasma or serum) and buffer drops included in the kit are placed.
The result can be read in the test window after 10 minutes.
BioMaxima also plans to launch its own genetic test to confirm if people have been infected with the virus using real-time PCR (Polymerase Chain Reaction).
According to the company, the test will use the most ‘effective and reliable method’ for identifying the genetic material of the virus, with the result expected in under two hours.
The test will be suitable for use in so-called open systems, on platforms of different manufacturers, already equipped with diagnostic laboratories.
Poland’s Office for Registration of Medicinal Products was unavailable for comment at the time of writing.