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BD ProbeTec™ HSV Qx Amplified DNA Assays: FDA-cleared for HSV1 and HSV2



BD ProbeTec™ Herpes Simplex Viruses Qx Amplified DNA Assays for the BD Viper™ System with XTR™ Technology

First fully automated, FDA-cleared molecular assays for HSV1 and HSV2

Where Sensitivity Advances Clinical Performance


What's the most critical factor facing clinical laboratories today?

Performance.

Achieving optimal performance means delivering results against a backdrop of unprecedented challenges, including:

  • Increasing demand for more stringent and better overall testing
  • Escalating healthcare costs
  • A shortage of qualified personnel
  • Expectations to deliver higher quality results faster, with fewer resources
  • Greater competitive pressures

What do these challenges mean when it comes to clinical testing for diseases caused by herpes viruses?

The rising prevalence of Herpes Simplex virus type 1 (HSV1) and Herpes Simplex virus type 2 (HSV2) and the need for a better understanding of underlying health risks are increasing the demand for more stringent and better overall testing.

Yet research data suggests that many clinical laboratories continue to use traditional culture-based tests to diagnose herpes virus infections, which can result in significant false negative rates and missing up to 50 percent of true positive cases1. In addition, many clinicians and laboratories do not distinguish between HSV1 and HSV2 - meaning patient treatment plans and patient outcomes can be negatively affected.

These limitations can lead to retesting, which is time-consuming and expensive, resulting in increased frustration and distrust from doctors and patients who require fast, accurate results.

In the end, what's the real cost of outdated technology to you, the physicians and the patients you serve?

For patients, continuing to test for HSV using traditional culturing methods can mean delayed treatment - or worse, the wrong treatment altogether.

For the physician, viral culture results can be affected by improper temperature requirements during transport, leading to false negative results. If the patient had a late-stage lesion that has healed, collecting another specimen may not be possible.

For your business, less efficient testing methods result in decreased productivity and, ultimately, increased cost. Not only are live culture tests costly in terms of price per test and additional labor, but also due to the requirement to transport viable organisms in a strict, secure manner. Together, these inefficiencies translate into a quantifiable negative impact on your laboratory's bottom line.

How can you improve your HSV testing performance and achieve positive economic impact?

As the first fully automated, FDA-cleared molecular assays for HSV1 and HSV2, the BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays deliver a complete solution for the clinical laboratory wanting performance plus profitability.

The BD ProbeTec Herpes Simplex Viruses Qx Amplified DNA Assays, when run on the BD Viper™ System in Extracted Mode, use Strand Displacement Amplification technology to qualitatively detect and differentiate HSV1 and HSV2 DNA in clinician-collected external anogenital lesion specimens as an aid in the diagnosis of herpes infection.

With this technology you can improve your laboratory's overall competitiveness by providing higher quality results for improved patient care, better lab efficiency and increased standardization. You'll also see a greater return on your investment through:

  • Improved detection rates - Alleviate the need for HSV1 vs. HSV2 reflex testing and reduce the need for retesting.
  • Decreased turnaround time - There is a significant improvement in the time-to-results over culture methods, which often take 2-10 days. The BD "load and go" HSV Assays provide the ability to read up to 96 results in about two and a half hours. With the BD Viper™ System with XTR™ Technology, clinical laboratories can also run tests for chlamydia and gonorrhea, along with HSV1 and HSV2 on a single automated run.
  • Reduced costs - In addition to the cost savings from excellent detection rates and eliminating the need for viable cultures and strict transport conditions, fully automated processing requires fewer resources and increases walk-away time.

The BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays run on the BD Viper™ System with XTR™ Technology, are designed to give clinicians better tools to manage patients who may be suffering from a variety of the most pressing sexually transmitted infections.

The BD ProbeTec Herpes Simplex Viruses (HSV1 & 2) Qx Amplified DNA Assays run on the BD Viper System with XTR Technology deliver:

  • High sensitivity
  • Simultaneous detection and differentiation of HSV1 & HSV2
  • Better sample quality, less stringent conditions for sample storage and transport
  • Mixed batch capability with CT/GC
  • Complete automation with the BD Viper System with XTR Technology
  • Room-temperature, ready-to-use, unit dose-based reagents
  • Quality of results and regulatory assurance
  • Established, documented clinical and analytical performance


Note: The BD ProbeTec HSV Qx 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.



1 N. Nguyen, C.N. Burkhart, C.G. Burkhart. 2010. Identifying potential pitfalls in conventional herpes simplex virus management. Int. J. Dermatol. 49: 987-993.
2 BD ProbeTec™ Herpes Simplex Viruses (HSV 1 & 2) Qx Amplified DNA Assays Package Insert, 8086121

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