Herpes simplex virus (HSV)

Adults and/or adolescents: Subject with genital lesions without known history of herpes

Antibodies to HSV are detected 2 weeks to 6 months after primary exposure1,2. A substantial proportion of newly-infected patients are positive for IgG and IgM, or IgG alone1,3,4. Despite the theory that IgM production ceases over time, levels of anti-HSV IgM can vary considerably after the primary infection and can be detected also due to recurrent episodes3,5. Approximately one-third of people infected with HSV-2 have detectable IgM with a recurrent infection. In addition, IgM tests cannot accurately distinguish between HSV-1 and HSV-2 antibodies and sometimes cross-react with other viruses in the same family6. For these reasons IgM testing is not recommended in routine clinical practice6-10.

Adapted from:

  1. American Sexual Health Association. Diagnosing Herpes. [Internet; updated 2024; cited 2024 Mar 5]. Available from: https://www.ashasexualhealth.org/herpes-testing/.
  2. Workowski, KA, et al. Sexually Transmitted Diseases Treatment Guidelines, 2021. MMWR Recomm Rep. 2021;70:29-36. [Internet; updated 2022 Sep 21; cited 2024 Mar 5]. Available from: https://www.cdc.gov/std/treatment-guidelines/herpes.htm.
  3. Sénat MV, et al. Prevention and management of genital herpes simplex infection during pregnancy and delivery: Guidelines from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Repr Biol. 2018;224:93-101.
  4. Patel R, et al. European guideline for the management of genital herpes. Int J STD AIDS. 2017;28:1-14.
  5. Groves MJ. Genital Herpes: A Review. Am Fam Physician. 2016;93:928-934.
  6. Riedel A, et al. P5.071 Evaluation of Elecsys Immunoassay System for Determination of Type-Specific IgG Antibodies to HSV-1 and HSV-2. Sex Transm Infect. 2013;89(Suppl 1):A1-A428.
  7. Gardella C and Brown ZA. Managing genital herpes infections in pregnancy. Cleve Clin J Med. 2007;74:217-224.
  8. Morrow R and Friedrich D. Performance of a novel test for IgM and IgG antibodies in subjects with culture-documented genital herpes simplex virus-1 or -2 infection. Clin Microbiol Infect. 2006;12:463-469.
  9. Whitley RJ and Miller RL. Immunologic approach to herpes simplex virus. Viral Immunol. 2001;14:111-118.
Product Description Tests Product page
Elecsys® HSV-1 IgG a) Electrochemiluminescence immunoassay (ECLIA) for the qualitative detection of IgG class antibodies to HSV‑1 in human serum and plasma 100
Elecsys® HSV-1 IgG b) 100
Elecsys® HSV-2 IgG a) Electrochemiluminescence immunoassay (ECLIA) for the qualitative detection of IgG class antibodies to HSV‑2 in human serum and plasma 100
Elecsys® HSV-1 IgG b) 100
cobas® HSV 1 and 2 Test c) Nucleic acid amplification test for the detection and typing of HSV-1 and HSV-2 DNA in clinician-collected anogenital lesion specimens 80
240

a) for use on the cobas® e 411 analyzer and the cobas® e 601 / 602 modules
b) for use on the cobas® e 402 and cobas® e 801 analytical units
c) for use on the cobas® 4800 System

HSV-1 IgG HSV-2 IgG HSV 1/2 DNA Results indicate
- - - Susceptible; consider at risk of infection to both types.
- - + Profile suggestive of an initial primary first episode of genital herpes
+ + Type 1 or 2 + Profile suggestive of recurrence.
+ - Type 1 +
- + Type 2 +
- + Type 1 + Profile suggestive of a non-primary first episode of genital herpes.
+ - Type 2 +

Adapted from:

  1. Workowski KA, et al. Sexually Transmitted Diseases Treatment Guidelines, 2021. MMWR Recomm Rep. 2021;70:29-36. [Internet; updated 2022 Sep 21; cited 2024 Mar 5]. Available from: https://www.cdc.gov/std/treatment-guidelines/herpes.htm.
  2. Piret J, et al. Immunomodulatory strategies in herpes simplex virus encephalitis. Clin Microbiol Rev. 2020;33:e00105-19.
  3. Sénat MV, et al. Prevention and management of genital herpes simplex infection during pregnancy and delivery: Guidelines from the French College of Gynaecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Repr Biol. 2018;224:93-101.
  4. Sauerbrei A. Optimal management of genital herpes: current perspectives. Infection and Drug Resistance. 2016;9:129–141.
  5. Kaneko H, et al. Evaluation of Mixed Infection Cases With Both Herpes Simplex Virus Types 1 and 2. Journal of Medical Virology. 2008;80:883–887.
  6. Brown ZA, et al. Genital herpes complicating pregnancy. Obstet Gynecol. 2005;106:845-856.
  7. Brown ZA. Use of Herpes Type-specific Serology to Prevent Neonatal Herpes Simplex Virus Infection. NeoReviews. 2004;5:e16-e21.
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Step 1
Subject with genital lesions without known history of herpes
Subject with genital lesions and known history of herpes
Subjects at risk without genital lesions and without known history of herpes
Subjects without genital lesions and no known history of herpes or with a partner with HSV
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Step 1

Perform HSV type-specific DNA* swabbing
of the lesions

(* if unavailable perform virus culture)

HSV-1 DNA
HSV-2 DNA
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Step 2

Perform HSV-1 IgG and HSV-2 IgG tests

HSV-1 IgG
HSV-2 IgG
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  • Step 2
  • Step 3
Step 2

Perform HSV-1 IgG and HSV-2 IgG tests

HSV-1 IgG
HSV-2 IgG
  • Step 1
  • Step 2
  • Step 3
Step 2

Perform HSV-1 IgG and HSV-2 IgG tests

HSV-1 IgG
HSV-2 IgG
  • Step 1
  • Step 2
  • Step 3
Step 2

Perform HSV-1 IgG and HSV-2 IgG tests

HSV-1 IgG
HSV-2 IgG
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  • Step 2
  • Step 3
Step 1

Perform HSV-1 IgG and HSV-2 IgG tests in parallel

HSV-1 IgG
HSV-2 IgG
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Summary

Swabbing is not recommended. If the lesion is atypical, perform PCR or culture and type specific antibody testing to confirm a recurrence.

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Summary

Serologic screening among the general popuplation is not recommended.
HSV serology testing might be needed for people at the highest risk or HIV positive.

Provide behavioral counselling interventions to reduce the likelihood of acquiring a sexually transmitted infection. Perform screening for other sexually transmitted infections, including chlamydia and gonorrhea, hepatitis B virus, human immunodeficiency virus, and syphilis.

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Summary

Provide education and counselling.

Consider the appropriate antiviral treatment options based on the HSV type involved.

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Summary

Susceptible; consider at risk of infection to both types.
Repeat serology in 8 to 12 weeks.

Reswab subsequent lesions.
Consider differential diagnosis.

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Summary

In cases of recent suspected HSV-2 acquisition, repeat type-specific antibody testing 12 weeks after the presumed time of acquisition is indicated.
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Summary

Presence of HSV-1 antibodies does not distinguish between oral and genital infection.
Patient at risk for acquiring orolabial or genital HSV-2 infections.

Provide education and counselling.

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Summary

Provide education and counselling.
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Summary

Provide education and counselling.
Step
Result
Interpretation
1
Testing of adults and/or adolescents = ...
1
Subject with genital lesions without known history of herpes
The clinical differentiation of genital HSV infection from other infectious (Treponema pallidum, Haemphilus ducrey) and non-infectious etiologies of genital ulceration is often difficult and laboratory confirmation of the infection should always be sought.
1
Subject with genital lesions and known history of herpes
1
Subjects at risk without genital lesions and without known history of herpes
1
Subjects without genital lesions and no known history of herpes
1
HSV-1 DNA = ...
HSV-2 DNA = ...
waiting for input
1
HSV-1 DNA = positive
HSV-2 DNA = negative

Genital HSV-1 infection is confirmed.

Perform HSV-1 IgG and HSV-2 IgG tests.

1
HSV-1 DNA = negative
HSV-2 DNA = positive

Genital HSV-2 infection is confirmed.

Perform HSV-1 IgG and HSV-2 IgG tests.

1
HSV-1 DNA = positive
HSV-2 DNA = positive

Genital HSV infection confirmed.

Perform HSV-1 IgG and HSV-2 IgG tests.

1
HSV-1 DNA = negative
HSV-2 DNA = negative

Genital HSV infection is not confirmed.

​​​​​​​Perform HSV-1 IgG and HSV-2 IgG tests.

2
HSV-1 IgG = ...
HSV-2 IgG = ...
waiting for input
2
HSV-1 IgG = positive
HSV-2 IgG = negative

Simultaneous recurrent HSV-1 and primary HSV-2 infection /mixed infection (rare)

2
HSV-1 IgG = negative
HSV-2 IgG = positive
Non primary HSV-2, first episode of HSV-1
2
HSV-1 IgG = positive
HSV-2 IgG = positive
Recurrent HSV-1 infection, latent HSV-2
2
HSV-1 IgG = negative
HSV-2 IgG = negative
Initial primary first episode of HSV-1 / acute HSV-1 infection
2
HSV-1 IgG = ...
HSV-2 IgG = ...
waiting for input
2
HSV-1 IgG = positive
HSV-2 IgG = negative
Non primary HSV-1, first episode of HSV-2
2
HSV-1 IgG = negative
HSV-2 IgG = positive
Recurrent HSV-2 infection
2
HSV-1 IgG = positive
HSV-2 IgG = positive
Recurrent HSV-2 infection, latent HSV-1
2
HSV-1 IgG = negative
HSV-2 IgG = negative
Initial primary first episode of HSV-2 / acute HSV-2 infection
2
HSV-1 IgG = ...
HSV-2 IgG = ...
waiting for input
2
HSV-1 IgG = positive
HSV-2 IgG = negative
Simultaneous recurrent HSV-1 and primary HSV-2 infection / mixed infection (rare)
2
HSV-1 IgG = negative
HSV-2 IgG = positive
Simultaneous recurrent HSV-2 and primary HSV-1 infection / mixed infection
2
HSV-1 IgG = positive
HSV-2 IgG = positive
Simultaneous recurrent HSV-1 and HSV-2 infection / mixed infection
2
HSV-1 IgG = negative
HSV-2 IgG = negative
Simultaneous primary HSV-1 and HSV-2 infection / mixed infection (rare)
2
HSV-1 IgG = ...
HSV-2 IgG = ...
waiting for input
2
HSV-1 IgG = positive
HSV-2 IgG = negative
Previous HSV-1 infection (latent HSV-1)
2
HSV-1 IgG = negative
HSV-2 IgG = positive
Previous HSV-2 infection (latent HSV-2)
2
HSV-1 IgG = positive
HSV-2 IgG = positive
Previous HSV-1 and HSV-2 infection (latent HSV-1 and HSV-2)
2
HSV-1 IgG = negative
HSV-2 IgG = negative
Susceptible; consider at risk of infection to both types
1
HSV-1 IgG = ...
HSV-2 IgG = ...
waiting for input
1
HSV-1 IgG = positive
HSV-2 IgG = negative
Presence of HSV-1 antibodies does not distinguish between oral and genital infection.
1
HSV-1 IgG = negative
HSV-2 IgG = positive
Presence of type-specific HSV-2 antibody implies anogenital infection.
1
HSV-1 IgG = positive
HSV-2 IgG = positive
HSV-1 and HSV-2 past-infections.
1
HSV-1 IgG = negative
HSV-2 IgG = negative
Patient at risk for acquiring orolabial or genital HSV-1 infection and/or HSV-2 infections.
End of test sequence