We ve Come a Long Way Baby! Forget the cigare7es, I want a vaginal swab!

Transcription

1 We ve Come a Long Way Baby! Forget the cigare7es, I want a vaginal swab!

2 Who I am Director, Infec@ous Diseases Laboratory at University of Alabama at Birmingham School of Medicine I captured Chlamydia with my own swab!! Research focus on chlamydia and other STI epidemiology & diagnos@cs for >30 years

3 Who I work with [Financial Disclosures] I have received financial support in the form of research grants, honoraria or other support from the following companies in the last 2 years: Abbo7 Molecular BD Diagnos@cs Beckman Coulter Cepheid Copan Roche Molecular Diagnos@cs

4 Topics & Learning obtained Vaginal Swabs When are they appropriate? How do they impact flow? What about non- genital specimens? The Role of Rapid Results What seyngs would benefit from rapid Seasonal in STI rates When do they occur? What should we do about them?

5 Self- Obtained Samples: Not really news Schachter, J, WM McCormack, MA Chernesky, DH B Van Der Pol, PA Rice, et al. Vaginal swabs are appropriate specimens for diagnosis of genital tract with Chlamydia trachoma<s. J Clin Microbiol. 2003; 41: Hobbs MM, B Van Der Pol, P To7en, CA Gaydos, A Wald, T Warren, et al. From the NIH: proceedings of a workshop on the importance of self- obtained vaginal specimens for detec@on of sexually transmi7ed infec@ons. Sex Transm Dis. 2008; 35:8-13 CDC STD Laboratory Diagnos@c Guidelines 2009

6 100.0% 95.0% 90.0% 85.0% 80.0% 75.0% 70.0% Vaginal Self Vaginal Clinician Endocervical Urine Adapted from: Schachter et al. JCM 2003, Van Der Pol, et al. JCM 2012, Van Der Pol, et al. STD 2012, Gaydos et al. JCM 2013

7 Another Way to Look at Sample Types Van Der Pol, et al. STD 2012

8 Is the Difference Meaningful? Usually the order of is: Vaginal> Endocervical>Urine>LBC This is a consistent finding spanning >10 years and seen on EVERY major diagnos@c plamorm A meta- analysis of all clinical trial data would be useful Clinician and pa@ent- obtained vaginal swabs are equivalent in quality, but there may be other advantages to pa@ent- obtained sampling

9 IF THE DIFFERENCE IS SLIGHT WHY SHOULD THE PARADIGM CHANGE?

10 Disadvantages to Change We ve always done it this way or at least since the 1990 s Laboratorians are to blame for the dogma: The only good quality sample comes from the endocervical os We needed viable organisms for culture!

11 And Some<mes a clinician just needs to take a look and visualize what is going on down there AGREED! Screening vs. Diagnosis Asymptoma@c women following screening guidelines The Worried Well, Morning- Aqer Remorse Contacts to STDs? Need for a pelvic no use for a vaginal swab

12 Advantages Improved clinic flow Cost advantages involvement

13 Involvement Health behavior theories describe factors that encourage of services Self- efficacy Lack of barriers Locus- of- control Respect

14 Cost Advantages modeling (n~10,000), STD clinic Endocervical swab Self- obtained vaginal swab First- catch urine Outcome: cases of PID prevented Self- obtained Vaginal swab was least expensive AND most cost- effec6ve Blake et al. STD 2008

15 Improving Flow Sample

16 Process Register /Sign- in Wait Results called or mailed to Rx called in or makes 2 nd visit Provide urine specimen Clinician collects CT/GC sample See clinician Sign- out/ Pick up treatment?

17 Self- Obtained Samples Register /Sign- in Wait Results called or mailed to Rx called in or makes 2 nd visit Provide urine specimen Minor Prac@ce Change 1. Clinician Pa@ent collects CT/GC sample See clinician Sign- out/ Pick up treatment?

18 With On- Site Register /Sign- in Wait Provide urine specimen See clinician If on- site labs, Wait Results to clinician See clinician Clinician collects CT/GC sample Sign- out/ Pick up treatment?

19 Self- Obtained Samples & On Site Register /Sign- in Wait Results called or mailed to Rx called in or makes 2 nd visit Pa@ent collects CT/GC sample Provide urine specimen See clinician Results to clinician Wait for results begins BEFORE seeing clinician Sign- out/ Pick up treatment?

20 to Consider How long do wait from being seen by a clinician? Are staff available to run the assay? How long un@l results are ready? One size will NEVER fit all!!! Rapid tes@ng is not appropriate in every seyng, but may offer substan@al pa@ent management benefits in some seyngs Hard to reach popula@ons (e.g. prenatal visits for women who do not rou@nely use services, Emergency Departments) In seyngs where wai@ng is acceptable

21 Self- obtained samples in other seyngs

22 Flu, yes. STIs, not so much

23 Non- Genital

24 Rectal Self- Sampling Works well with molecular Recommended annually for anyone (male or female) who engages in anal intercourse Acceptable to (for many of the same reasons as vaginal swabs!) Oropharyngeal sampling takes a li7le more training

25 Would you consider an ano- rectal test? Yes No Don't Know Didge et al.,

26 how would you prefer to be tested? Self Clinician No Preference

27 AND NOW FOR SOMETHING COMPLETELY DIFFERENT

28 DON T LET YOUR CLIENTS RE- GIFT CHLAMYDIA!

29 I have a Social Disease An appropriate euphemism! Social events may lead to Partner change Unplanned ac@vi@es (and perhaps unprotected) Disinhibi@on Screening is essen@al given that 60-80% of chlamydial infec@ons are asymptoma@c!!

30 January February March April May June July August September October November December January February March April May June July August September October November December

31 Spring Break Survival Kit

32 Look at Your Data Break down data by clinic or seyng Look for recurring temporal trends Encourage of that coincides with peak events This may be facilitated by self- obtained samples No exam rooms No sinks No toilets Just swabs and Purell!

33 Support Screening! Self- Obtained Samples Can Help

34 LET S WRAP IT UP!

35 Take Home Messages Self- obtained vaginal swabs Perform at least as well as other samples types and probably be7er than urine and LBC Are acceptable to women Can improve clinic flow & reduce costs Rectal (& oropharyngeal) swabs are acceptable to as well Seasonal/Event- related pa7erns of STI should be used as triggers for screening events

36 & Comments Encouraged!!

37 P.A.C.E Credits (Archived Webinar) Please go to the following website by either clicking the link below or by entering the address in your browser Follow the and upon your will arrive in the mail in about 6 weeks h7p://cepheid.pace.vanderpol.ques@onpro.com