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Herpes simplex virus (HSV-1 and HSV-2)
Answering an unmet need with diagnostic solutions
A common and lifelong infection
Herpes Simplex Virus (HSV) is one of the most common Sexual Transmitted Infections (STI). It is spread through oral and/or genital sexual contact and it persists in the human body for life. Since the infection often has mild symptoms or none at all, detecting the presence of antibodies in the blood is a reliable method to identify the disease.
The virus has two serotypes: herpes simplex type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2). More than 3.7 billion people worldwide under the age of 50 are infected with HSV-1 and HSV-2, while an estimated 417 million people aged 15-49 have HSV-2 infection.
HSV-1 and HSV-2 are different viral infections that usually affect different parts of the body. Where HSV-1 is commonly transmitted from person to person through kissing and usually causes cold sores around the mouth, HSV-2 is primarily spread through sexual contact, and symptomatically exhibits lesions on the genitals. Though less common, HSV-1 may be transmitted to the genitals of a partner, and HSV-2 may be transmitted to the mouth of a partner through oral sex.
Determining the type of HSV a person is infected with has an important impact on patient management and treatment decisions—HSV-2 recurrence is considerably higher than that of HSV-1.1
Molecular testing by polymerase chain reaction (PCR) technology is regarded as the most sensitive method of direct detection for HSV-1 and HSV-2.2
Economic burden of HSV-23
HSV-2 is responsible for an estimated $540.7 million per year in the US, and is one of the most overlooked STIs.3,4 Clinical presentation for HSV infection is frequently varied. Signs and symptoms can be easily confused with other conditions, further complicating efforts for detection and treatment of infection.
Approximately 70 to 90% of patients with reactive serology for HSV-2 have not been diagnosed with genital herpes.
Severe health consequences
Untreated and undiagnosed HSV can lead to varying and severe health consequences, including painful chronic infection, miscarriage or premature birth, and fatal infection in newborns.
Differing outcomes regarding disease severity, sequelae, and recurrence rates, make it essential to differentiate between HSV-2 or HSV-1 infections.
Important role of laboratories
For all patients with suspected genital herpes, laboratory confirmation is recommended using methods that directly demonstrate the virus in genital specimens.
Herpes viruses are continuing to evolve and evidence of drug resistance is being reported. Laboratories play an increasingly important role in accurately identifying and typing HSV to direct therapy, prevent recurrence, and limit transmission of the virus.
Herpes Simplex Virus (HSV)
Herpes simplex virus (HSV) is among the most prevalent sexually transmitted infections. Most genital Herpes infections in the United States are caused by HSV-2; however, genital HSV-1 infections are increasing among college students and other populations. 5
The incidence of genital Herpes simplex continues to rise, increasing the testing burden on the laboratory. Cell culture and PCR are the preferred HSV tests for persons who seek medical treatment for genital ulcers or other mucocutaneous lesions. 6
A patient's prognosis and the type of counseling needed depend on the type of genital Herpes (HSV-1 or HSV-2) causing the infection; therefore, the clinical diagnosis of genital Herpes should be confirmed by type-specific laboratory testing.5
Nucleic Acid Amplification Tests such as PCR provide the high sensitivity and specificity required for STI testing with fully automated systems that deliver quick turnaround time.
cobas® HSV 1 and 2 Test
The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated FDA-cleared test for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.
Anogenital lesion swab specimens for cobas® HSV 1 and 2 testing are collected with the MSwab Collection, Transport and Preservation Kit.
Primary specimens are loaded directly on the cobas® 4800 System for testing; no manual pipetting required.
Specimens collected with the MSwab kit are suitable for bacterial culture of gram positive aerobic and facultative anaerobic organisms, virus culture of HSV 1 and HSV 2, and nucleic acids detection of bacteria and viruses.*
Mixed run capabilities: cobas® HSV 1 and 2 testing can be performed with the cobas® CDiff and cobas® MRSA tests on the cobas® 4800 system.
* Refer to the COPAN MSwab Collection, Transport and Preservation System Package Insert for culture processing instructions. To avoid crosscontamination, it is recommended that primary tubes be processed on the cobas 4800 system prior to removing aliquots for culture.
cobas® 4800 System
Fully automated sample preparation with real-time polymerase chain reaction (PCR) technology for amplification and detection.
World Health Organization (WHO). Herpes simplex virus. http://www.who.int/mediacentre/factsheets/fs400/en/. Accessed May 13, 2016.
Patel et al. 2011 European guidelines for the management of genital herpes. Int J STD and AIDS. 22(1):1-10.
CDC Self-Study STD Modules for Clinicians [https://www2a.cdc.gov/stdtraining/self-study/herpes/hsv_self_study_epidemiology.html] Accessed October 10, 2018
CDC Genital Herpes Statistics [https://www.cdc.gov/std/herpes/stats.htm] Accessed October 10, 2018
Sexually Transmitted Disease Surveillance 2014, CDC Division of STD Prevention, November 2015
Sexually Transmitted Diseases Treatment Guidelines, MMWR, Recommendations and Reports / Vol. 64 / No. 3 June 5, 2015
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