The second-generation GenomEra SARS-CoV-2 is a rapid and highly sensitive multiplex RT-qPCR test for the detection of SARS-CoV-2 from respiratory samples. Only a short and simple sample preparation is needed, after which the assay is fully automated, and the result will be automatically interpreted with Ct values after 50 minutes.
“The new sample preparation method in GenomEra SARS-CoV-2 2.0 Assay kit is much faster than the previous method. Now there is no unnecessary waiting times and the test results are also available very fast,” Roosa Jamsen, hospital microbiologist from Fimlab Vaasa clinical laboratory in Finland, says.
The assay is compatible with a wide range of commercial sample collection media available, including inactivating media. If the sample is collected to an inactivating media, it allows safe handling of the sample without the need for extensive biosafety measures and minimises the hands-on time. Additionally, the new assay includes an integrated sample processing control targeting a specific human housekeeping gene mRNA.
The performance of the test was evaluated in a multisite study carried out in autumn 2021. In total, 915 samples were compared with another RT-PCR method and the results were excellent: overall sensitivity was 98.3% and specificity 99.8%.
“Due to the high performance of the test and the fast assay time, we find it an excellent choice for Covid-19 testing. During the pandemic, the availability of the method has also been an important selection criterion, and it has been excellent with GenomEra tests all the time,” Jamsen summarises.
Enabling the right diagnosis
GenomeEra products, like the SARS-CoV- 2 2.0 Assay Kits, are developed and produced in Finland by Abacus Diagnostica, part of Uniogen. Uniogen is a global pioneer in clinical diagnostics, point-of-care testing, and instruments for life sciences. Its goal is to enable the right diagnosis and care at the first patient appointment. With point-of-care testing for infectious diseases and cancer diagnostics, among others, it provides patients and healthcare with faster, easier and more cost-effective diagnosis.
Through contract development and manufacturing, Uniogen also provides laboratory instruments and tests for heart diseases and detection of coronavirus antibodies. Its Upcon system, consisting of brightly luminescent upconverting nanoparticles, instruments and software, brings great benefits to point-of-care testing. Uniogen is also developing the first total solution for point-of-care testing on the market that allows both antibody and PCR testing and thereby diagnostics for several diseases to be performed simultaneously with a single, versatile and easy-to-use device – in virtually any healthcare setting and without special expertise.
Uniogen was established when Abacus Diagnostica, a front runner in molecular testing and rapid PCR tests, Kaivogen, a specialist in immunoassays and antibody testing, and Labrox, an innovator of high-technology laboratory instruments and diagnostic readers, joined forces in the beginning of 2022. The company is headquartered in Turku, Finland.
Uniogen is exhibiting at ECCMID, which takes place in Lisbon on 23–26 April 2022. Visit its booth 2-33 in pavillion 3. At the booth, you can try the new sample processing method used in the GenomEra SARS-CoV-2 2.0 Assay kit and get a small gift. Visitors can also view the abstract and poster #00955 – Evaluation of analytical and clinical performances of the second-generation GenomEra SARS-CoV- 2 assay kit by Mogghadam, Persley, Faramarz, Vainio, Tapio, and Martelin.
