Automated Tests Detect and Differentiate HSV DNAs

Automated molecular tests will help clinicians in the diagnosis and treatment of Herpes simplex viruses, or HSV, one of the most common sexually transmitted infections in the world.

The two HSV assays will significantly improve accuracy and time to results over culture methods. In addition, the automated assays will provide laboratories with the capability to read up to 96 positive or negative results in about two and a half hours.

Products of Becton, Dickinson and Co. (Franklin Lakes, NJ, USA) ProbeTec HSV-1 and HSV-2 Qx Amplified DNA assays will run on the Viper System with XTR Technology, which uses Strand Displacement Amplification technology to qualitatively detect and differentiate HSV-1 and HSV-2 DNA in clinician-collected external anogenital lesion specimens.

The company said data suggest that laboratories using current culture methods to diagnose HSV often experience significant false-negative rates. "When caring for a patient who may be suffering from HSV, clinicians need a precise picture of what they are dealing with," said Wayne Brinster, vice president and general manager, women's health and cancer, BD Diagnostics.

"Determining whether a patient has HSV and whether it is type 1 or 2 makes a big difference in how the infection is treated, especially with the increase in new anti-viral and suppressive therapies," he added.

BD Diagnostics has filed for US Food and Drug Administration (FDA; Silver Spring, MD, USA) 510(k) clearance for the fully automated molecular tests to diagnose and differentiate HSV types 1 and 2.

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Becton, Dickinson and Co.
US Food and Drug Administration