EUROIMMUN AG from Lübeck in Germany, a manufacturer of reagents and automated systems for medical laboratory diagnostics, has developed a PCR test for direct virus detection, in addition to the assays for the detection of antibodies against SARS-CoV-2 (ELISA). The new test is a real-time reverse transcriptase PCR used to detect the genetic material of SARS-CoV-2. Both test systems are currently only available as research-use-only products. Update from 31.03.2020: Both ELISAs as well as the PCR test have received CE mark by now.
At the end of January the World Health Organisation (WHO) declared the new infectious disease COVID-19, caused by a novel coronavirus (SARS-CoV-2), a global health emergency. Starting in the Chinese city of Wuhan, Hubei province, SARS-CoV-2 has been spreading to the rest of the world since the end of last year. As of 11 March 2020 the WHO has reported over 118,326 infections and 4,292 deaths.
Coronaviruses constitute a large family of viruses which can infect people and animals, for example birds and mammals. Coronavirus infection can lead to a simple cold, but also to severe or even fatal disease. In the outbreaks of severe acute respiratory syndrome (SARS) in 2002/2003 and Middle East respiratory syndrome (MERS) in 2012/2013, hundreds of people died.
As with other infectious diseases, PCR-based and serological tests are suited for the investigation of patients suspected to be infected with the new coronavirus. The PCR technology plays a major role particularly in the early phase of a viral infection, in which the virus multiplies significantly, and is useful for direct pathogen detection. Serological tests are designed to detect antibodies in the blood. They are used when the immune system has already reacted to the pathogen.
EUROIMMUN started developing a new test shortly after the outbreak had become known. Only a few weeks later, two ELISAs for the detection of Anti-SARS-CoV-2 antibodies of classes IgA and IgG were available. These products are now supplemented by the EURORealTime SARS-CoV-2 for direct virus detection. Both test systems are currently only available to research institutions as research-use-only products. Preparations for CE registration of these tests are underway.
“The EURORealTime SARS-CoV-2 was developed for specific detection of the new coronavirus. The test detects two different genetic sequences simultaneously and is therefore very sensitive,” explained Dr. Ulf Steller, Head of the Division Molecular Genetic Diagnostics at EUROIMMUN AG. Antibody detection systems such as the Anti-SARS-CoV-2-ELISAs are the ideal supplement to direct virus detection. “Moreover, testsystems for detection of antibodies of class IgG can be used to gather epidemiological data,” said Katja Steinhagen, Head of the Division Immunobiochemistry Infection Diagnostics.
With the development of the EURORealTime SARS-CoV-2 and Anti-SARS-CoV-2-ELISAs, EUROIMMUN again reacts in a very short time to a newly emerging viral disease. EUROIMMUN was the first company to offer diagnostic test systems for the outbreaks of viral infections with SARS-CoV in 2002/2003, MERS-CoV in 2012/2013 and Zika virus in 2015/2016.