Self-Obtained Vaginal Swabs in STI Testing

1. Region IIInfertility Prevention ProjectNew York City, New YorkDecember 12-13, 2007 Richard Steece, Ph.D., D(ABMM) National Infertility Prevention Project DrRSteece@aol.com

2. Region IIInfertility Prevention Project • Alternate Swabs • Rectal swabs • Pharyngeal swabs • Vaginal swabs • Penile swabs • Multiplex Tests • Utilization of Single Test Technology

3. Nucleic Acid Amplification Tests (NAATS) • Polymerase Chain Reaction (PCR) • Roche • Strand Displacement Amplification (SDA) • Becton Dickinson • APTIMA Combo 2 Assay (TMA) • GenProbe • APTIMA CT and GC (TMA) • GenProbe

4. Alternate Swabs • Rectal swabs • Pharyngeal swabs • CDC/FDA • Dr. Papp – CDC • Laboratory Guidelines • Consultation

5. VERIFICATION OF THE GENPROBE APTIMA COMBO 2 ASSAY FOR THE DETECTION OF C. trachomatis and N. gonorrhoeae FROM RECTAL AND PHARYNGEAL SWABS THOMAS R. SHARPTON, MS, SM(ASCP) CHIEF, VIROLOGY SECTION UTAH PUBLIC HEALTH LABORATORIES

6. Alternate Swabs • Vaginal Swabs - as specimens for the diagnosis of chlamydia infections • Self-obtained vaginal swabs (SOV)

7. Vaginal Swabs as Specimens for the Diagnosis of Chlamydial Infections • APTIMA Combo 2 Assay (TMA) • GenProbe • APTIMA CT and GC (TMA) • GenProbe • FDA cleared – “Patient-collected vaginal swab specimen application is limited to health care facilities where support/counseling is available to explain the procedures and precautions.”

8. The Importance of Self-Obtained Vaginal Specimens for Detection of Sexually Transmitted Infections (STI) The National Institute of Allergy and Infectious Diseases Diagnostics Workshop Organized by: Diagnostics Working Group of the Sexually Transmitted Infections and Topical Microbicides Cooperative Research Centers of NIAID June 27, 2006 Bethesda, MD

9. Workshop Goal Review published data and current field practices to support test development and FDA clearance for self-obtained vaginal specimens (SOVs) for STI testing

10. For detection of STIs in women, self-obtained vaginal specimens perform… …as well as clinician-obtained specimens …better than urine …as well as or better than cervical swabs

11. INTERNET RECRUITED HOME SAMPLING FOR CHLAMYDIA USING SELF-OBTAINED VAGINAL SAMPLES: CAN WE REACH POPULATIONS AT RISK? Charlotte A. Gaydos, MS, DrPH Associate Professor Division of Infectious Diseases Johns Hopkins University 23rd IUSTI Europe Cavtat/Dubrovnik Croatia

12. OBJECTIVES • To ascertain whether use of the Internet to recruit women to perform home vaginal sampling for Chlamydia trachomatis can reach at-risk women • To determine prevalence, behavioral risk factors, and satisfaction for this type of outreach screening

13. METHODS-Use of the Kit • Website: www.iwantthekit.org • Program: began 2004 • Publicity: Papers, Magazines, Radio, Flyers • Kits mailed to homes from email/phone requests: total requested since 2004: 3249 • Kits contained consent form, swab, instructions, questionnaire, contact form, return mailer • Returned: 30.6%

14. METHODS- Use of the Female Kit • Vaginal swabs mailed in a dry state • Each swab aliquot tested by a multiple nucleic acid amplification tests (NAATs) for CT & GC • PCR (Roche) • SDA (Becton Dickinson) • TMA (GenProbe) • Two different positive NAAT results required to call a sample positive

15. RESULTS- Use of the Female Kit • Analysis of vaginal swabs: • Requested by Internet email: 95.2%, Phone: 4.8% • Of 930 tested through July 13, 2007 • 86 (9.3%) CT positive* • 13 (1.4%) GC positive* • *(6 co-infected w/ CT and GC) • Of 259 tested for Trichomonas since Sept: • 20 (7.7%) positive** • ** (1 co-infected w/ CT and GC)

16. Other Sites • Spokane Regional Health District • Washington State Public Health Department • San Francisco City Public Health Department

17. Alternate Swabs • Penile swabs • Meatal swabs

18. Use of the Internet for Screening Males for Sexually Transmitted Diseases: Prevalence, Satisfaction, and Risk Factors Charlotte A. Gaydos1, MS, DrPH Mathilda Barnes1, BS Bulbul Aumakhan1, MD Billie Jo Wood1, MS Patricia Rizzo-Price1, MS Nicole Quinn1 , BS Pamela Whittle2, BS M. Terry Hogan1, MPH 1.Johns Hopkins University 2. Baltimore City Health Department Baltimore, Maryland

19. Background • www.iwantthekit.org is an Internet based educational program for recruiting sexually active persons to collect samples at home for screening themselves for chlamydia, gonorrhea and trichomonas • Women (N = 993) have been screened since 2004 • Screening for men began in Sept 2006 (N = 93)

20. OBJECTIVES • To ascertain if males would request home sampling kits for STDs via the Internet for collection of urogenital samples at home • To determine the perception and opinions of the participants about the program • To measure STD prevalence, demographics, and behavioral risk factors of males users

21. METHODS • Kits: consent form, swab, instructions, questionnaire, contact form, return mailer • Kits mailed to patient’s home after email/phone request • Urine and self-collected penile swabs tested • TMA APTIMA (GenProbe) transport media used • Urine collected on Copan Uriswab “sponge stick” • Penile swab was “flocked swab” (Copan) • Kits returned by U.S. mail • Samples tested for chlamydia, gonorrhea, and trichomonas using nucleic acid amplification tests (NAATs, TMA, GenProbe)

22. Results (N=93) • Men returned 21.1% of requested kits; all but 3 men submitted the penile swab along w/ urine; all but 12 used Internet to request kits; others phone • Prevalence CT: 19.4% • GC: 0% • Trichomonas 1.3% • Good agreement between urine & penile swabs: • 4 penile swabs chlamydia positive were negative by urine; others in agreement • Median age (p=0.12) • for CT infected was 21.5 yr. (mean 22.3, range 16-36) • for CT uninfected was 23 yr. (mean 27.3, range 17-63)

23. Other Studies Male “Self Collected” Glans/Urethral Dry Swab Specimens Tested with the Becton Dickinson ProbeTec ET System Detects Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) Dennis Ferrero, Diane Schultz, Nancy Burgess, Stephen Willis, and Stef Argintean 107th General Meeting of the American Society of Microbiology. 2007. Abstract C-116 j

24. Results • 284 male patients attending an STD cllinic were tested for CT and GC using clinician collected swab (CCS), first void urine (FVU), and self-collected glans/urethral swab (SCS) • 51 positive specimens for either CT and GC (CT prevalence 12%, GC prevalence 5.6%) • Overall sensitivity of SCS was 91% with a specificity of 99%

25. Multiplex Tests • What is a Multiplex Test? • “Test which can detect one or more agents from a single specimen, in a single run” • E.g. GenProbe Aptima Combo 2

26. Multiplex Tests • CDC – DSTDP – Laboratory Branch • Developed an in-house Multiplex PCR test for genital ulcer disease (syphilis, chancroid, and HSV)

27. Utilization of Single Test Technology • What is single test technology? • Single test to detect CT used to screen for CT • Cost savings • Don’t routinely test for GC • Don’t use NAAT for GC, may use culture • Single test to increase positive predictive value (PPV), e.g. repeat test, supplemental or “confirmatory test”

28. Repeat Testing • Theoretical Consideration (2002 CDC Guidelines) • Test a second specimen with a different test that uses a different target, antigen, or phenotype and different format. • Test the original specimen with a different test that uses a different target, antigen, or phenotype and a different format. • e.g. screen with Gen-Probe Aptima Combo 2 (AC2), retest with Gen-Probe Aptima CT or Roche Amplicor or Becton Dickinson ProbeTec • Repeat the original test on the original specimen with a blocking antibody or competitive probe • Repeat the original test on the original specimen • e.g. screen with AC2, retest with AC2.

29. Utilization of Single Test Technology • Sixteen (16) public health laboratories use AC2 and/or ACT and AGC • Fifty-eight (58) private laboratories use AC2 and/or ACT and AGC • Most laboratories (public and private) that use ACT and/or AGC use in conjunction with AC2 • Seven (7) US Non-Public health laboratories and 5 public health laboratories use ACT with AC2 and without AGC