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Aptima HSV 1 & 2 Assay (CE-IVD)

The Aptima HSV 1 & 2 assay joins the growing menu of Aptima assays on the fully automated Panther system. This CE-IVD certified nucleic acid amplification test (NAAT) is used for the qualitative detection and differentiation of herpes simplex virus (HSV) types 1 (HSV-1) and 2 (HSV-2).1 Specimens may be collected using the Aptima Multitest Swab Specimen Collection Kit or with viral transport media (VTM).1

This assay is not available for sale in the U.S. Please contact your local sales representative for product availability.

About

About the Assay

The Aptima HSV 1 & 2 assay is an in vitro real-time NAAT test for the qualitative detection and differentiation of messenger RNA from HSV-1 and HSV-2.1

This assay is intended for use as an aid in the differential diagnosis of HSV-1 and HSV-2 infections in symptomatic patients.1 This assay is compatible with clinician-collected swab specimens from lesions in the anogenital and oral regions.1 Specimens may be collected with the Aptima Multitest Swab or with VTM.1

This assay utilizes target capture, transcription mediated amplification (TMA), real-time detection and an internal control.1

About the Herpes Simplex Virus

More than 3.7 billion people globally are infected with HSV-1 or HSV-2.3 Both types of this virus can infect the oral or genital mucosa.3 They create recurrent lesions and viral shedding on the mouth and anogenital areas.3 The Aptima HSV 1 & 2 assay detects and differentiates between both HSV types.

The identification of which type of HSV is present is important to:

  • Prevent transmission from an infected sex partner to a non-infected partner.3
  • Prevent transmission from infected mothers to neonates.3
  • Guide patient treatment and daily management.3
  • Help patients take precaution toward HIV-1 transmission and acquisition, which are more common in HSV-infected patients.3

Herpes has historically been diagnosed using empirical assessment by health care practitioners or cell culture in a virology laboratory.Now, Aptima HSV testing is available on the fully automated Panther system with better sensitivity than culture.5

The Aptima HSV 1 & 2 assay is not available for sale in the U.S.

Application

The Aptima® HSV 1 & 2 assay may be used with two specimen collection options1:

  • Aptima Multitest Swab
  • Viral Transport Media

Samples may be collected by a clinician or a patient by swabbing a lesion in the anogenital or oral areas during an HSV outbreak.1

Performance

The Aptima HSV 1 & 2 assay has better performance than traditional culture. This performance information is located in the Aptima HSV 1 & 2 assay package insert.1

 

The Aptima HSV 1 & 2 assay is not available for sale in the U.S.

Reference

1. Aptima HSV 1 & 2 assay [package insert]. AW-15346-001, Rev. 001. San Diego, CA: Hologic, Inc.; 2016. 2. WHO. Globally, an estimated two-thirds of the population under 50 are infected with herpes simplex virus type 1 [press release]. Geneva, Switzerland: World Health Organization: October 28, 2015. 3. World Health Organization. Herpes simplex virus. http://www.who.int/mediacentre/factsheets/fs400/en/. Published January 2016. Accessed October 5, 2016. 4. LeGoff J, et al. Diagnosis of genital herpes simplex virus infection in the clinical laboratory. Virol J. 2014;11:83. doi:10.1186/1743-422X-11-83. 5. Hook EW. A new look at genital herpes: the critical role of the laboratory in diagnosis and management. Medical Laboratory Observer. http://www2.mlo-online.com/features/201207/cover-story/a-new-look-at-gen.... Published July 2012. Accessed October 5, 2016.