Abacus Diagnostica, a company of Uniogen, has introduced the second-generation GenomEra SARS-CoV-2 2.0 Assay Kit in the European market for the detection of Covid-19.

The Finnish company said that its new-generation assay kit has recently received CE mark for in-vitro diagnostic medical devices in Europe.

GenomEra SARS-CoV-2 2.0 has been developed to detect the presence of SARS-CoV-2 virus in the respiratory samples, and deliver results within 50 minutes.

It requires sample to be collected to an inactivating sample collection media, avoiding the need for extensive safety measures or dedicated PCR facilities.

Following a short and simple sample preparation, the kit completes the test in a fully automated process, and the results are interpreted after 50 minutes.

GenomEra SARS-CoV-2 2.0 offers rapid PCR test results with a high sensitivity of 98.3% and high specificity of 99.8%, said Abacus.

Each assay kit allows simultaneously analysis of up to four samples, and the capacity can be extended to 32 samples by combining up to eight instruments.

Also, the test performance is not affected by emergence of new Covid-19 variants, as the test simultaneously detects two different targets in the virus genome, said the company.

Uniogen is a developer of point-of-care diagnostic testing kits to identify pathogens from one single sample with PCR.

In March last year, Abacus Diagnostica developed a SARS-CoV-2 Variants of Concern (VoC) Assay for the GenomEra CDX platform.

In addition to detecting all SARS-CoV-2 strains, the new test was developed to identify clinically significant deletions present in the variants first identified in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1).

The test was offered as a research use only product.