Fully Automated Assay Detects and Differentiates HSV-1 and HSV-2

The assay for HSV-1 and HSV-2 is an in vitro diagnostic test for the direct, qualitative detection of the herpes simplex virus (HSV-1 and HSV-2) DNA in male and female genital or oral lesions and cerebral spinal fluid (CSF).

The assay utilizes the Polymerase Chain Reaction (PCR) to generate an amplified product from the Glycoprotein-D and UL-30 genes of HSV-1 and HSV-2, respectively that are present in clinical specimens. There are advanced automation flexible sample preparation options of 24, 48, 72, or 96 samples per run. An extensive m2000 test menu for infectious disease allows for platform consolidation. Detection from genital or oral lesion swabs and cerebral spinal fluid (CSF) provides more options in patient testing. The assay differentiates between HSV-1 and HSV-2 detection, allowing for specific disease state management. A maxRatio data analysis performs multiple validity checks on each patient result for improved confidence in result reporting.

This is the fourth test in IMDx’s (Waltham, MA, USA) portfolio of infectious disease tests for use on Abbott’s fully-automated m2000 system to receive US Food and Drug Administration (FDA; Silver Spring, MD, USA) clearance in the past 10 months. HSV-1 and HSV-2 are the most common causes of oral and genital lesions and are spread through sexual and skin-to-skin contact.

The IMDx HSV-1/2 for Abbott m2000 test is intended for use as an aid in the diagnosis of HSV infection in symptomatic patients and is not FDA-cleared for use with cerebrospinal fluid or for prenatal screening. IMDx designs, develops, and manufactures platform agnostic, regulatory-cleared molecular diagnostic tests that enable partners to more rapidly and efficiently expand test menus. Beyond growing its portfolio of assays for infectious disease, IMDx is pursuing new targets in companion diagnostics, oncology and human genetics, as well as next generation instrument systems.

Related Links:
IMDx
US Food And Drug Administration