1. 1 Update on Diagnostic Tests For Genital Herpes 14 Case Studies National STD Prevention Conference Chicago, IL March 12, 2008 Peter Leone MD, Chapel Hill, NC Gary A Richwald MD, Los Angeles, CA

2. 2 The term “swab test” is used to represent herpes culture” and PCR. PCR is clearly a superior swab test but is not in wider use because of expense and limited availability in most outpatient settings. In the future, PCR will likely replace herpes culture.

3. 3 There are five type-specific HSV antibody tests (TSSTs) currently available in the US. Three of the five tests are laboratory based and two (Biokit and HerpeSelect ® Express ™ ) are point of care.

4. 4 HerpeSelect ® Express ™ HSV-2 IgG serology test Four step procedure Results in 15 minutes Small sample size –15 uL serum –20 uL whole blood (capillary or venous) Room temperature storage Control line HSV-2 positive HSV-2 negative

5. 5 Case 1 25 yr old male with itchy and painful vesicles and ulcers typical of genital herpes (GH) at the base of his penis. Has never had history of genital lesions. Has had six sex partners since becoming sexually active at age 15. Had penile-vaginal intercourse with regular partner a few days ago.

6. 6 Case 2 21 yr old female with recurrent dysuria and vaginitis. Has had three treated episodes of vaginitis in past eight months. Bacterial urine cultures negative x2 and tests for BV, trich and yeast negative as well. Test for chlamydia negative. Has had antibacterial therapy for suspected bacterial UTI and been treated with metrinidazole and antifungals for suspected vaginitis.

7. 7 Case 3 20 yr old male with recurrent “jock itch” for the past year and half. Treated with OTC antifungals. Inflammation disappears about a week after treatment but recurs typically one to two months later. KOH and fungal cultures are negative.

8. 8 Case 4 16 yr old male has been sexually active for six months with one female sex partner. He has a first GH lesion on the head of his penis. Most of his sexual activity has been receptive oral sex, with occasional penile-vaginal intercourse.

9. 9 Case 5 21 yr old female with new 25 yr old male sex partner of one month who has history of recurrent GH for past five years, about 2-4 breakouts per year. He uses episodic treatment for herpes outbreaks. She has never had a GH outbreak and was screened a month before meeting him and had a negative TSST for HSV-2.

10. 10 Case 6 35 yr old male patient has had genital herpes outbreaks for three years. He just met a new woman with whom he thinks he is likely to have penile-vaginal intercourse in the next few weeks. He asks his clinician what he should do about his GH.

11. 11 Case 7 30 yr old male having a physical exam tells his primary care provider (PCP) that he has had five female and one male sexual partner in the past year. He denies any genital symptoms. PCP decides to screen him for STDs and wants to know which tests to order.

12. 12 Case 8 23 yr old female was told she had genital herpes four years earlier when she went to student health service for a sore spot in the area between the vagina and anus. She has had no genital symptoms since then. She now wants to know if she really has GH, what kind, and what to do about it if she has it.

13. 13 Case 9 40 yr old female has first outbreak of genital herpes on her labia. She would like to know whether John, her sex partner for the past three weeks, or Sergio, her previous sex partner who she last had sex with eight months ago, infected her.

14. 14 Case 10 45 yr old female in ER for evaluation for sexual assault by male assailant two days earlier. She was forced to have penile vaginal intercourse, anal intercourse and receptive oral sex.

15. 15 Case 11 30 yr old female, hx of HSV-2 GH for ten years. Now has 1-2 outbreaks per year on the vulva. She uses episodic treatment for bad outbreaks. Her new (for two months) male sex partner was diagnosed with HIV infection two years ago. They use condoms with every intercourse.

16. 16 Case 12 29 yr old male diagnosed with HIV three years ago. Has 7 year hx of recurrent HSV-2 GH, usually 3-4 outbreaks per year at base of penis. Has been on ART for HIV for one year and no longer reports GH outbreaks.

17. 17 Case 13 28 yr old pregnant female, no hx of GH lesions. Male partner has no hx of GH and has cold sore occasionally. At her first prenatal visit, she asks her pregnancy provider about STD screening. Her PCP wants to know which STD tests to order.

18. 18 Case 14 23 year old male in emergency room for “cut” on his penis from 4 days ago following vigorous intercourse. Triaged to urgent care, nurse practitioner strongly suspects genital herpes. Lesion is dry with small erythematous area. Patient is upset and does not think he could have genital herpes. Nurse practitioner wants to know which test to order.

19. 19 Who Is a Candidate for HSV Serologic Testing? Persons with clinical evidence of HSV Patient has typical GH lesion; culture/PCR not done or negative Patient originally diagnosed with HSV by clinical exam only without culture/PCR Patient has recurrent clinical symptoms of lower genital tract inflammation not explained by another diagnosis (patient does not have typical GH lesions) Note: Helpful in making definitive diagnosis, eliminating misdiagnoses, differentiating between genital HSV-2 and HSV-1 which have different prognoses. ASHA, Herpes Testing Toolkit, 2nd edition, 2006

20. 20 Who Is a Candidate for HSV Serologic Testing? Testing driven by patient risk-profile or request Patient with a previous or a current partner with GH Patient needs STD screening due to risk status Patient requests STD screening Patient requests HSV testing Patient is being evaluated for sexual assault Note: For patients in a relationship, HSV status will help determine if the patient or partner(s) would benefit from suppressive therapy to reduce transmission to uninfected partner(s). ASHA, Herpes Testing Toolkit, 2nd edition, 2006

21. 21 Pregnant women Patients prior to transplant or starting immunosuppressive therapy Patients with HIV infection Patients at risk for sexual acquisition of HIV infection Note: HSV-2 infected pregnant women should be offered a month of suppressive therapy prior to delivery. HSV-2 increases the risk of HIV transmission and HIV acquisition and can accelerate HIV progression. Who Is a Candidate for HSV Serologic Testing? Special populations ASHA, Herpes Testing Toolkit, 2nd edition, 2006