Skip to main content
Premium Trial:

Request an Annual Quote

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.

The Scan

Study Finds Sorghum Genetic Loci Influencing Composition, Function of Human Gut Microbes

Focusing on microbes found in the human gut microbiome, researchers in Nature Communications identified 10 sorghum loci that appear to influence the microbial taxa or microbial metabolite features.

Treatment Costs May Not Coincide With R&D Investment, Study Suggests

Researchers in JAMA Network Open did not find an association between ultimate treatment costs and investments in a drug when they analyzed available data on 60 approved drugs.

Sleep-Related Variants Show Low Penetrance in Large Population Analysis

A limited number of variants had documented sleep effects in an investigation in PLOS Genetics of 10 genes with reported sleep ties in nearly 192,000 participants in four population studies.

Researchers Develop Polygenic Risk Scores for Dozens of Disease-Related Exposures

With genetic data from two large population cohorts and summary statistics from prior genome-wide association studies, researchers came up with 27 exposure polygenic risk scores in the American Journal of Human Genetics.