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Aptima HSV 1 & 2 Assay

The Aptima HSV 1 & 2 assay joins the growing menu of Aptima assays on the fully automated Panther system. This 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).1,2

 

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-2.1,2

This assay is intended for use as an aid in the differential diagnosis of HSV-1 and HSV-2 infections in symptomatic patients.1,2 This assay is compatible with clinician-collected swab specimens from lesions.1,2 Refer to package inserts for additional information. Specimens may be collected with the Aptima Multitest Swab or with VTM.1,2

This assay utilizes target capture, transcription mediated amplification (TMA), real-time detection and an internal control.1,2

About the Herpes Simplex Virus

24 million people are infected with HSV-2 in the US and 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.4 They create recurrent lesions and viral shedding on the mouth and anogenital areas.4 

Differentiating between HSV-1 and HSV-2 is important to:

  • Identify risk of transmission to neonates and among sex partner(s).4
  • Guide patient treatment and disease management.4

Herpes has historically been diagnosed using empirical assessment by healthcare 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.9

 

Application

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

  • Aptima Multitest Swab
  • Viral Transport Media

Refer to the package inserts for proper sample collection.

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 inserts.1,2

Please refer to package inserts by country for specific information.

 

Reference
  1. Aptima HSV 1 & 2 assay [package insert]. AW-15346-001, Rev. 001. San Diego, CA: Hologic, Inc.; 2016.

  2. Aptima HSV 1 & 2 assay [package insert]. AW-15636-001, Rev. 001. San Diego, CA: Hologic, Inc.; 2017

  3. CDC. Incidence, Prevalence and Cost of Sexually Transmitted Infections in the United States. http://www.cdc.gov/std/stats/sti-estimates-fact-sheet-feb-2013.pdf. Published February 2013. Accessed May 4, 2017.

  4. World Health Organization. Herpes simplex virus.http://www.who.int/mediacentre/factsheets/fs400/en/. Published January 2016. Accessed May 4, 2017.

  5. Wald A, et al. Oral shedding of herpes simplex virus type 2. Sex Transm Infect. 2004;80(4):272-276. doi:10.1136/sti.2003.007823.

  6. Freeman EE. Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies. AIDS. 2006;20(1):73-83.

  7. Sami L. Gottlieb, et.al. Journal of Infectious Diseases 2002, Seroprevalence and Correlates of Herpes Simplex Virus Type 2 Infection in Five Sexually Transmitted Disease Clinics.

  8. 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.

  9. 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 May 4, 2017.