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Dx Focus: IMDx Gets CE Mark for HSV-1/2 Assay on Abbott m2000


IMDx said this week that it has received CE marking for its HSV-1/2 assay for use on the Abbott m2000 System.

The IMDx HSV-1/2 is designed to detect herpes simplex virus viral DNA and differentiate between HSV-1 and HSV-2 in male and female genital or oral lesions and cerebral spinal fluid.

The assay is fully automated and can test up to 94 patient samples simultaneously in less than six hours with minimal hands-on time, as results are obtained using a direct swab taken from a symptomatic 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 assay demonstrated 100 percent sensitivity and 97.2 percent specificity for HSV-1; and 100 percent sensitivity and 98.8 percent specificity for HSV-2.

The assay is not available for sale in the US or Canada.

This is IMDx's fourth assay for use on the Abbott m2000. Other tests include real-time PCR assays for group B Streptococcus, vancomycin-resistant Enterococci, and toxigenic Clostridium difficile.