News | July 6, 2022

New GenomEra Assay Kit For Rapid Detection Of Viruses Causing Viral Meningitis CE-Marked

Abacus Diagnostica launches new GenomEra assay kit for rapid detection of viruses causing viral meningitis

Abacus Diagnostica, a Uniogen company and Finnish frontrunner in molecular testing, is launching a new rapid PCR test in the European markets for the fast identification of viruses causing viral meningitis and encephalitis. The CE-marked GenomEra assay kit (HSV-1/2, VZV + EV Assay Kit) allows healthcare professionals to determine in 70 minutes whether a meningitis is caused by the four most common viruses, allowing proper treatment to be started immediately and unnecessary use of antibiotics avoided. The test can also detect herpes infection (HSV-1 and HSV-2) from skin lesion swab samples. The assay kit has recently received European CE marking for In Vitro Diagnostic (IVD) medical devices according to the requirements of EU Directive 98/79/EC (IVDD).

“The test detects the four most common viruses causing viral meningitis from cerebrospinal fluid sample in just one test. In the traditional diagnostics of meningitis, separate assays are used, and the time from sampling to results often takes several hours, which can delay the diagnosis and thus also lead to the unnecessary use of antibiotics,” Erno Sundberg, CEO of Abacus Diagnostica tells.

Viral meningitis is typically caused by Herpes simplex 1 and 2 viruses, Varicella-zoster virus (VZV), or enteroviruses (EV). Although viral meningitis is not as severe as acute bacterial meningitis, which often requires urgent hospital care, some patients seek treatment for unpleasant symptoms. The doctor cannot determine whether the meningitis is caused by a virus or bacteria on the basis of the symptoms alone, so the patient is usually started on antibiotics until bacterial meningitis is ruled out.

Developed and manufactured in Finland, the GenomEra test system can be used in almost any healthcare unit, as it is easy to use requiring virtually no special expertise. The automated test system consists of test chips and a GenomEra CDX instrument that automatically interprets the test result after short and simple sample processing.

Clinical trials in three European hospitals in April-May 2022 have demonstrated that the assay kit provides rapid PCR test results with high sensitivity (92.3% probability that the test is positive if the patient has HSV-1/2, VZV or EV infection) and excellent accuracy (99.9% probability that the test is negative if the patient does not have HSV-1/2, VZV or EV infection).

“We started developing the test as early as 2019, but during the COVID-19 pandemic, the focus of our product development shifted to the development of COVID-19 rapid tests. On the other hand, thanks to this extra time, the results were even better. We have launched a test that is easy to use, has shown superior specificity in performance evaluations and combines the simplicity of the assay process with the excellent sensitivity of the PCR method. I would like to take this opportunity to thank our talented Abacus Diagnostica team for the great outcome,” Sundberg says.

Source: Uniogen