GenomEra® 2.0 assay kit for COVID-19 CE marked – introduces second-generation usability and sensitivity to PCR testing 

Posted 10 months ago on

Abacus Diagnostica, part of Uniogen, is launching its second-generation COVID-19 test, the GenomEra® SARS-CoV-2 2.0 Assay Kit in the European market. The assay kit has recently received European CE marking for In Vitro Diagnostic (IVD) medical devices.  

It is intended for healthcare professionals, and it detects the SARS-CoV-2 virus in respiratory samples in 50 minutes. 

  • The assay kit provides rapid PCR test results with excellent sensitivity (98.3%) and high specificity (99.8%). 
     
  • The sample is collected to an inactivating sample collection media, which means that neither extensive safety measures nor dedicated PCR facilities are required. 
  • After a short and simple sample preparation, the assay process is fully automated. The results are automatically interpreted after 50 minutes. With one GenomEra® test system, up to four samples can be analysed at the same time. Capacity can be extended to 32 samples by combining up to eight instruments.  
  • The test performance is not affected by emergence of different COVID-19 variants, as the test simultaneously detects two different targets in the SARS-CoV-2 virus genome 
    – the RdRp and E genes. 

Press release

More information: SARS-CoV-2 2.0