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Draft Recommendation Statement

Serologic Screening for Genital Herpes

August 16, 2022

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

This topic is being updated. Please use the link(s) below to see the latest documents available.

Recommendation Summary

Population Recommendation Grade
Asymptomatic adolescents and adults, including pregnant persons The USPSTF recommends against routine serologic screening for genital herpes simplex virus infection in asymptomatic adolescents and adults, including pregnant persons. D

Additional Information

Tools
Related Resources
  • Serologic Screening for Genital Herpes (Consumer Guide): Draft Recommendation | Link to File

Full Recommendation:

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

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Genital herpes is a common sexually transmitted infection (STI) caused by two related viruses, herpes simplex type 1 (HSV-1) and herpes simplex type 2 (HSV-2).1,2 HSV-1 causes both orofacial and anogenital infection; HSV-2 rarely presents outside of the anogenital area.1 Infection is lifelong; currently, there is no cure for HSV infection. Antiviral medications may provide symptomatic relief from intermittent outbreaks. Vertical transmission of HSV (from the pregnant person to the child) can occur, most commonly during delivery; when genital lesions or prodromal symptoms are present, cesarean delivery can reduce risk of transmission.3,4 Neonatal herpes infection is uncommon yet can result in substantial morbidity and mortality. Currently, routine serologic screening for genital herpes is limited by the low predictive value of widely available serologic screening tests and the expected high rate of false-positive results likely with routine screening of asymptomatic persons in the United States.

Over the past 20 years, HSV-1 and HSV-2 seroprevalence has steadily declined,1 yet certain populations remain disproportionately affected by HSV infection. The 2015–2016 National Health and Nutrition Examination Survey estimates seroprevalence of HSV-1 to be highest in Mexican American (71.1%) and non-Hispanic Black (58.8%) persons compared with the general U.S. population (48%).5 Estimated seroprevalence of HSV-2 in U.S. non-Hispanic Black adolescents and adults (34.6%) is nearly 3 times that of the general U.S. population (12.1%).5 In pregnant persons, an estimated 22% of the U.S. population may be seropositive for HSV-2.1 HSV seroprevalence increases with economic deprivation2 and decreases with educational attainment,6 suggesting that HSV disparities may be influenced by social determinants of health.

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Using a reaffirmation process, the U.S. Preventive Services Task Force (USPSTF) concludes with moderate certainty that the harms outweigh the benefits for population-based screening for genital HSV infection in asymptomatic adolescents and adults, including pregnant persons.

See the Table for more information on the USPSTF recommendation rationale and assessment. For more details on the methods the USPSTF uses to determine the net benefit, see the USPSTF Procedure Manual.7

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Patient Population Under Consideration

This recommendation statement applies to adolescents and adults, including pregnant persons, without known history, signs, or symptoms of genital HSV infection. This recommendation statement does not apply to persons with a history (or signs or symptoms) of genital herpes, persons who are between symptomatic outbreaks and not experiencing symptoms, or persons with HIV infection or other immunosuppressive disorders.

Definitions

In this recommendation statement, “asymptomatic” refers to persons without known past or current history of genital herpes and includes persons who may have unrecognized infection.1 Persons who are known to have genital herpes and are between outbreak occurrences are not considered to be asymptomatic. “Genital herpes” refers to a range of signs and symptoms related to HSV infection in the sacral nerve area.1 Many persons with genital herpes have intermittent, recurrent genital ulcers or vesicular lesions and may have local symptoms (e.g., itching) or systemic signs (e.g., fever).1

Treatment and Interventions

Treatment of persons with symptoms of genital herpes can include antiviral medications to provide symptomatic relief from painful outbreaks. The Centers for Disease Control and Prevention (CDC) provides detailed guidance for diagnosis and management of genital herpes, including counseling to prevent sexual and perinatal transmission.4

Additional Tools and Resources

The following resources may assist clinicians in implementation of strategies to prevent STIs in the primary care setting.

Other Related USPSTF Recommendations

The USPSTF has issued several related recommendations to prevent negative health outcomes related to STIs, including the following.

  • Behavioral counseling interventions to prevent STIs14
  • Screening for chlamydia and gonorrhea15
  • Screening for HIV infection16
  • Screening for syphilis infection in nonpregnant adolescents and adults17
  • Screening for syphilis infection in pregnant persons18
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Scope of Review

To reaffirm its recommendation, the USPSTF commissioned a reaffirmation evidence update.1 The aim of the evidence update that supports the reaffirmation process is to identify new and substantial evidence sufficient enough to change the prior recommendation.7 The reaffirmation update focused on targeted key questions to systematically evaluate the evidence on accuracy, benefits, and harms of routine serologic screening for HSV-2 infection in asymptomatic adolescents, adults, and pregnant persons. Additionally, evidence was sought on the effectiveness and harms of preventive medications and behavioral counseling interventions in asymptomatic populations to reduce future symptomatic episodes and transmission to susceptible sexual partners and infants.

The reaffirmation update that supports this recommendation found no new evidence since the 2016 review.1 In 2016, the USPSTF reviewed 17 studies (n=9,736) in 19 publications.19,20 The USPSTF reviewed evidence comparing accuracy of HerpeSelect (Focus Diagnostics; Cypress, California) and the Biokit HSV-2 Rapid Test (American Screening, LLC; Shreveport, Louisiana), two commercially available serologic tests approved by the U.S. Food and Drug Administration, with the western blot (the criterion standard).1,20 Serologic tests can detect antibodies to HSV infection typically 6 weeks to 3 months after infection.1

Accuracy of Screening Tests

The USPSTF found no new studies assessing the accuracy of serologic screening for HSV-2 in asymptomatic adolescents, adults, and pregnant persons. Based on foundational evidence from the 2016 review of 11 studies (n=7,129), accuracy estimates of HSV-2 serologic tests, which are largely derived from populations with higher prevalence of HSV-2 infection compared with the general U.S. population, are of limited applicability to the general U.S. primary care population.20 In a population with an HSV-2 seroprevalence of 16% (estimated seroprevalence in the United States in 2016), the positive predictive value for the Biokit test may be as low as 75% and as low as 50% for HerpeSelect.8 Estimated declines in HSV-2 seroprevalence in the U.S. population (since 2016) likely further limit test predictive value.20 Confirmatory testing with the highly specific western blot is not widely available, further complicating population-wide screening in the United States.1,20 No studies have examined the screening accuracy of serologic tests for HSV-2 in pregnant women.1,20

Studies report many new cases of genital herpes may be caused by HSV-1; while HSV-1 infection can be identified by serologic tests, it is highly prevalent (≈48%), and tests cannot determine the site of infection (oral or anogenital).1,20 Therefore, serologic tests are not useful for routine screening for asymptomatic genital herpes from HSV-1 infection.1,20

Risk Assessment

The USPSTF found no evidence of externally validated, reliable risk stratification tools to identify individuals more or less likely to have genital herpes.1,20

Benefits of Early Detection and Treatment

The USPSTF found no new studies evaluating effectiveness of antiviral medications to reduce genital HSV-2 viral shedding or effectiveness of antiviral medications or behavioral counseling interventions to reduce future symptomatic episodes or transmission of genital herpes in asymptomatic adolescents, adults, and pregnant persons.1 Based on evidence in the 2016 evidence review, the USPSTF found limited and heterogenous evidence of benefit of early identification and early treatment of HSV-2 in asymptomatic adults, including pregnant persons.8,20 Genital herpes has no cure; the role of antiviral medications in asymptomatic persons is unclear.1 Pregnant persons with active genital lesions or prodromal symptoms can be managed with cesarean delivery to reduce the risk of neonatal transmission.1 Given these findings, the USPSTF concluded that routine screening for HSV-2 in asymptomatic persons would confer no more than a small population benefit.

Harms of Screening and Treatment

The USPSTF found no new studies reporting on the harms of screening for or treatment of genital herpes in asymptomatic adolescents, adults, and pregnant persons. Based on foundational evidence, the USPSTF found that nearly 1 out of every 2 diagnoses in the general U.S. primary care population using widely available serologic tests for HSV-2 could be false.20 In a population of 100,000 persons with an HSV-2 prevalence of 16%, serologic screening could result in approximately 15,840 true-positive and 15,960 false-positive results.20 Additionally, the USPSTF concluded that there may be potential social and emotional harms associated with a false-positive diagnosis20 and potential harms of unnecessary treatment with preventive antiviral medications in persons with a false-positive diagnosis.

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The USPSTF recognizes the importance of improving screening for and treatment of genital herpes to prevent future symptomatic episodes and transmission. The USPSTF is calling for more studies to evaluate screening, detection, and management of asymptomatic genital HSV infection, including the following.

  • Studies assessing screening test accuracy and predictive value in primary care settings in the United States that include asymptomatic persons, compare results with the western blot, and clearly describe handling of indeterminate test results.
  • High-quality, consistent evidence of effective behavioral counseling interventions, preventive medication interventions (e.g., antiviral medications), or both that improve genital herpes outcomes in asymptomatic adolescents and pregnant persons who screen positive for HSV.
  • Studies to assess persons for whom screening may most benefit are a high priority; development of externally validated and reliable risk stratification tools are needed that can be utilized in the primary care setting.
  • Studies should enroll enough participants from populations disproportionately affected by HSV to understand effective prevention strategies in these specific populations.
  • Improved epidemiologic data on the true prevalence and incidence of genital HSV infection, especially neonatal herpes infection, in the United States.
  • Research to better clarify emerging associations of HSV infection with intermediate pregnancy outcomes (such as preterm labor and prolonged rupture of membranes) and potentially related neonatal morbidity and mortality.
  • Research to better understand the potential role of HSV infection in increasing the risk of HIV infection and the management of coinfection with HSV and HIV.
  • Research to develop a cure for genital HSV infection and an effective vaccine to prevent genital HSV infection should continue.
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The American Academy of Family Physicians supports the 2016 USPSTF recommendation against routine serologic screening for HSV infection in asymptomatic adolescents, adults, and pregnant persons.21 The American College of Obstetricians and Gynecologists does not recommend routine serologic screening for HSV in asymptomatic pregnant persons.3 For pregnant persons with a clinical history suggestive of HSV without laboratory confirmation, HSV screening may be helpful, and repeat serologic testing may be indicated.3 In symptomatic pregnant persons, antiviral therapy may be indicated; cesarean delivery is recommended for pregnant persons with active genital lesions or prodromal symptoms.3 The CDC does not recommend routine serologic screening for HSV-2 in asymptomatic persons, including pregnant persons.22 The CDC provides detailed guidelines for prevention and management of genital HSV in adolescents, adults, and pregnant persons, including consideration of HSV-2 serologic testing in certain scenarios.22 The CDC recommends counseling persons diagnosed with genital herpes to prevent sexual and perinatal transmission.22

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1. Asher G, Feltner C, Harrison W, Schwimmer M, Rains C, Jonas D. Serological Screening for Genital Herpes: A Reaffirmation Evidence Update for the U.S. Preventive Services Task Force. Evidence Synthesis No. 224. AHRQ Publication No. 22-05296-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2022.
2. Stebbins RC, Noppert GA, Aiello AE, Cordoba E, Ward JB, Feinstein L. Persistent socioeconomic and racial and ethnic disparities in pathogen burden in the United States, 1999-2014. Epidemiol Infect. 2019;147:e301.
3. American College of Obstetricians and Gynecologists. Management of genital herpes in pregnancy: ACOG Practice Bulletin, Number 220. Obstet Gynecol. 2020;135(5):e193-e202.
4. Centers for Disease Control and Prevention. Sexually Transmitted Infections Treatment Guidelines, 2021: Genital Herpes. https://www.cdc.gov/std/treatment-guidelines/herpes.htm. Accessed July 18, 2022.
5. McQuillan G, Kruszon-Moran D, Flagg EW, Paulose-Ram R. Prevalence of herpes simplex virus type 1 and type 2 in persons aged 14-49: United States, 2015-2016. NCHS Data Brief. 2018;(304):1-8.
6. Xu F, Markowitz LE, Gottlieb SL, Berman SM. Seroprevalence of herpes simplex virus types 1 and 2 in pregnant women in the United States. Am J Obstet Gynecol. 2007;196(1):43.e1-46.e1.
7. U.S. Preventive Services Task Force. Procedure Manual. https://uspreventiveservicestaskforce.org/uspstf/about-uspstf/methods-and-processes/procedure-manual. Accessed July 18, 2022.
8. US Preventive Services Task Force. Serologic screening for genital herpes infection: US Preventive Services Task Force recommendation statement. JAMA. 2016;316(23):2525-2530.
9. Centers for Disease Control and Prevention. How You Can Prevent Sexually Transmitted Diseases. https://www.cdc.gov/std/prevention/. Accessed July 18, 2022.
10. Centers for Disease Control and Prevention. Complete Listing of Risk Reduction Evidence-Based Behavioral Interventions. https://www.cdc.gov/hiv/research/interventionresearch/compendium/rr/complete.html. Accessed July 18, 2022.
11. Centers for Disease Control and Prevention. Provider Pocket Guides. https://www.cdc.gov/std/products/provider-pocket-guides.htm. Accessed July 18, 2022.
12. Centers for Disease Control and Prevention. A Guide to Taking a Sexual History. https://www.cdc.gov/std/treatment/sexualhistory.htm. Accessed July 18, 2022.
13. The Community Guide. HIV, STIs and Teen Pregnancy. https://www.thecommunityguide.org/topic/hiv-stis-and-teen-pregnancy. Accessed July 18, 2022.
14. US Preventive Services Task Force. Behavioral counseling interventions to prevent sexually transmitted infections: US Preventive Services Task Force recommendation statement. JAMA. 2020;324(7):674-681.
15. US Preventive Services Task Force. Screening for chlamydia and gonorrhea: US Preventive Services Task Force recommendation statement. JAMA. 2021;326(10):949-956.
16. US Preventive Services Task Force. Screening for HIV infection: US Preventive Services Task Force recommendation statement. JAMA. 2019;321(23):2326-2336.
17. US Preventive Services Task Force. Screening for syphilis infection in nonpregnant adults and adolescents: US Preventive Services Task Force recommendation statement. JAMA. 2016;315(21):2321-2327.
18. US Preventive Services Task Force. Screening for syphilis infection in pregnant women: US Preventive Services Task Force reaffirmation recommendation statement. JAMA. 2018;320(9):911-917.
19. Feltner C, Grodensky C, Ebel C, et al. Serologic screening for genital herpes: an updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2016;316(23):2531-2543.
20. Feltner C, Grodensky C, Ebel C, et al. Serological Screening for Genital Herpes: An Evidence Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 149. AHRQ Publication No. 15-05223-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2016.
21. American Academy of Family Physicians. Genital Herpes Simplex Virus Infection. https://www.aafp.org/family-physician/patient-care/clinical-recommendations/all-clinical-recommendations/genital-herpes.html. Accessed July 18, 2022.
22. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187.

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Rationale Assessment
Detection
  • The USPSTF found adequate evidence that currently available, FDA-approved serologic screening tests for HSV-2 have low specificity and a high false-positive rate for population-based screening. There is also a lack of widely available confirmatory testing.
  • Although serologic tests can detect the presence of HSV-1, seropositivity for HSV-1 does not indicate the site of infection, limiting usefulness of serological testing to identify asymptomatic genital herpes.
Benefits of early detection and intervention and treatment The USPSTF found adequate evidence to bound* the potential benefits of serologic screening for genital herpes in asymptomatic adolescents and adults, including pregnant persons, as no greater than small, based on the natural history and epidemiology of genital HSV infection and limited evidence of benefits of screening and early treatment in asymptomatic persons.
Harms of early detection and intervention and treatment The USPSTF found adequate evidence to bound* the potential harms of screening in asymptomatic adolescents and adults, including pregnant persons, as at least moderate, based on evidence of high false-positive rates of the screening tests in asymptomatic populations, potentially resulting in anxiety and disruption of personal relationships related to diagnosis.
USPSTF assessment The USPSTF concludes with moderate certainty that the harms outweigh the benefits for population-based screening for genital HSV infection in asymptomatic adolescents and adults, including pregnant persons.

*When direct evidence is limited, absent, or restricted to select populations or clinical scenarios, the USPSTF may place conceptual upper or lower bounds on the magnitude of benefit or harms.7

Abbreviations: FDA=U.S. Food and Drug Administration; HSV=herpes simplex virus; USPSTF=U.S. Preventive Services Task Force.

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