Finnish company Abacus Diagnostica is set to launch the GenomEra SARS-CoV-2 2.0 Assay Kit, its second-generation Covid-19 test, in the European market.
The assay recently received the CE mark for in vitro diagnostic (IVD) medical devices.
The multiplex RT-qPCR test is designed for the detection of the SARS-CoV-2 virus from respiratory samples.
With 98.3% sensitivity and 99.8% specificity, the assay provides rapid PCR test results in 50 minutes.
Designed for use by healthcare professionals, the new Covid-19 test comprises an integrated sample processing control that targets the mRNA gene.
The GenomEra platform combines the sensitivity of PCR methods and the simplicity of rapid testing in a single system.
The test process includes the collection of samples in an inactivating media and sample preparation.
GenomEra is fully automated after the sample preparation.
Up to four samples can be analysed simultaneously using one test system. By combining up to eight instruments, the capacity of the assay can be extended to 32 samples.
Abacus Diagnostica CEO Erno Sundberg said: “After further development, we are now proud to be able to offer this second-generation Covid-19 test.
“The fast and reliable test takes the usability to a whole new level. Additionally, the test has shown outstanding sensitivity and specificity in performance evaluations.”
The GenomEra SARS-CoV-2 2.0 Assay can identify two different targets, the RdRp and E genes, in the SARS-CoV-2 virus genome at that same time. Because of this, its performance is not affected by the emergence of different variants of Covid-19.
The company noted that the Horizon 2020 research and innovation programme of the European Union provided funding for the GenomEra 2.0 development project.