IntelligentMDx (IMDx) has obtained the CE mark for its fourth automated, high-throughput molecular test designed and developed for the Abbott m2000 System. The IMDx HSV-1/2 test detects herpes simplex virus (HSV) viral DNA and differentiates HSV-1 and HSV-2 in male and female genital or oral lesions and cerebral spinal fluid.
HSV is the most common cause of genital and oral lesions, but can also invade other human tissue, occasionally causing keratitis, encephalitis, meningitis, and neonatal sepsis. Globally, IntelligentMDx reports, an estimated 4 billion people are currently infected with HSV, and the worldwide incidence of HSV-1 infection is considered the second largest after the common cold.
"We are proud to play a role in easing the global burden of herpes virus infections through rapid and precise diagnostics," said Alice Jacobs, MD, Chairman & CEO of IMDx. "Automated, high-throughput molecular diagnostics are becoming the method of choice for fast and reliable diagnosis of infections. The robust performance and automated nature of the IMDx HSV-1/2 for Abbott m2000 assay can aid in the diagnosis of patients and support faster treatment decisions."
The IMDx HSV-1/2 for Abbott m2000 assay offers a fully automated method for accurate testing of up to 94 patient samples simultaneously in less than 6 hours. Minimal hands-on time is required; results are obtained using a direct swab taken from a symptomatic male or female patient. When compared against clinical samples classified for HSV-1 and HSV-2 using culture and a molecular reference method, the IMDx HSV-1/2 for Abbott m2000 demonstrated 100.0% sensitivity and 97.2% specificity for HSV-1, and 100.0% sensitivity and 98.8% specificity for HSV-2.
The IMDx HSV-1/2 assay is part of a series of infectious-disease diagnostic tests designed by IMDx for use on the Abbott m2000 system. The IMDx CE-marked test menu includes real-time PCR assays for the detection of Group B Streptococcus, vancomycin-resistant Enterococci (vanA/vanB) and toxigenic C. difficile.
The assay is CE-marked and is not available for sale in the U.S. or Canada.