Automated Tests Differentiate Sexually Transmitted Infections

The fully automated system, which uses Strand Displacement Amplification technology to identify the viral DNA qualitatively, will aid clinicians to diagnose symptomatic patients with HSV1 and HSV2.

The ProbeTec HSV-1 and HSV-2 Qx Assays will significantly improve accuracy and time to results over culture methods, which often take 2-10 days for results. The new automated HSV assays will provide laboratories with the capability to read up to 96 positive or negative results in a little over two hours. When utilizing the Viper System with XTR Technology, clinical laboratories also will be able to run tests for Chlamydia and gonorrhea, along with HSV-1 and HSV-2, on a single automated run.

Both the ProbeTec assays and the Viper System are products of BD Diagnostics (Franklin Lakes, NJ, USA). The ProbeTec assays have received US Food and Drug Administration (FDA, Silver Springs, MD, USA) 510(k) clearance for the first fully automated molecular tests to detect and differentiate HSV types 1 and 2 in external anogenital samples collected by the physicians. The assays are not FDA cleared for use with cerebrospinal fluid (CSF) or any lesions other than anogenital lesions. The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years.

Wayne Brinster, Vice President and General Manager at BD Diagnostics, said, "Our new HSV tests are part of a growing portfolio of molecular diagnostics that is designed to give clinicians better tools to manage patients who may be suffering from a variety of the most pressing sexually transmitted infections. Identifying HSV patients and determining whether they have a type 1 or 2 infection is critical to treating them effectively and preventing further spread of the disease."

Herpes virus infections are found worldwide, and without seasonal variation. It is estimated that worldwide 314.8 million females and 220.7 million males, ages 15 to 49, were living with HSV-2 infection. The global number of new infections annually is estimated at 23.6 million.

Related Links:
BD Diagnostics
US Food and Drug Administration