1. CDC Laboratory Update  Chlamydia and Gonorrhea Laboratory Guidelines  Overview of the APHL / CDC STD Steering Committee

2. Laboratory Recommendations for the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae Top Changes from 2002 Guidelines The findings and conclusions in this presentation are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention

3. Framework  Experts:  Public Health Laboratory Directors  STD Program Directors  STD Clinicians  STD Laboratory Researchers  FDA and CMS  Target Audience:  Laboratory Directors, technicians, clinicians and disease control personnel  Key Questions:  Refinements or gaps from the 2002 “ Screening Tests to Detect Chlamydia trachomatis and Neisseria gonorrhoeae Infections”  Reviewed literature and prepared tables of evidence prior to consultation meeting at CDC

4. Overview of Key Questions 1)Performance Characteristics:  Sensitivity and specificity of reported tests stratified by anatomic site 2)Screening Applications:  Optimal specimen type  Economic considerations 3)Laboratory Confirmation:  Repeat testing  Medico-legal issues

5. Meeting Summary: Performance Characteristics AAll culture and non-culture tests may generate false- positive results CClinician education NNucleic acid amplification tests (NAATs) have superior performance to all other tests PPerformance characteristics comparisons will be based on published data TThese are the tests labs should be using to detect CT and GC regardless of presentation CCulture is still useful in certain circumstances GGC susceptibility testing DDetect mutant strains SShould be maintained

6.  Serology  Should not be used for the Dx of non-LGV CT infections  Should not be used for the Dx of LGV rectal infections  Useful for the Dx of inguinal LGV infections  Direct Detection of LGV  All FDA cleared NAATs detect LGV and non-LGV CT but are unable to distinguish the strains  Lab developed assays have been reported for the direct detection of LGV but the data are insufficient to make a recommendation on their utility

7. CT / GC Recommendations: Infections of the Reproductive Tract (Female) 2002  A nucleic acid amplification test (NAAT) performed on an endocervical swab specimen, if a pelvic examination is acceptable; otherwise, a NAAT performed on urine.  Culture performed on an endocervical swab specimen.

8. CT / GC Recommendations: Infections of the Reproductive Tract (Female) 2011  A nucleic acid amplification test (NAAT) performed on an endocervical swab specimen, if a pelvic examination is acceptable  Vaginal swabs are the optimal specimen type for use with NAATs Studies demonstrate equal performance to endocervical swabs and slightly better performance than urine Ease of collection and transport  Urine if vaginal swabs are not accepted by the patient  Culture performed on an endocervical swab specimen when there is a need to assess GC isolates for resistance to front line antibiotics

9. CT / GC Recommendations: Infections of the Reproductive Tract (Male) 2002  A nucleic acid amplification test (NAAT) performed on an intraurethral swab specimen if collecting such a specimen is acceptable; otherwise, a NAAT performed on urine.  Culture performed on an intraurethral swab specimen 2011  NAAT performed on urine  Culture performed on an intraurethral swab specimen when there is a need to assess GC isolates for resistance to front line antibiotics

10. CT / GC Recommendations: Rectal and Pharyngeal Infections (CT) 2002  Culture performed on rectal or pharyngeal swab specimens; a C. trachomatis-major outer membrane protein (MOMP)-specific stain should be used. 2011  A nucleic acid amplification test (NAAT) performed on a rectal swab NAATs are not cleared for rectal specimens by the FDA  Too few pharyngeal CT infections for a meaningful comparison

11. CT / GC Recommendations: Rectal and Pharyngeal Infections (GC) 2002  Culture performed on rectal or pharyngeal swab specimens; a selective medium should be used with additional testing on colonies of typical oxidase-positive, Gram-negative diplococci. 2011  A nucleic acid amplification test (NAAT) performed on a rectal or pharyngeal swab NAATs are not cleared for these specimen types by the FDA  Culture performed on rectal or pharyngeal swab specimens when there is a need to assess GC isolates for resistance to front line antibiotics

12. CT / GC Recommendations: Supplemental Testing 2002  An additional test should be considered after a positive screening test if a false-positive screening test would result in substantial adverse medical, social, or psychological impact for a patient.  Consideration should be given to routinely performing an additional test after a positive screening test if the positive predictive value is considered low (e.g., <90%). 2011  Routine repeat testing of NAAT positive specimens is not recommended for CT  Routine repeat testing of NAAT positive specimens is not recommended for GC unless there are a significant number of false- positive test results, in clinical studies, due to cross-reaction with non-gonococcal Neisseria species

13. CT / GC Recommendations: Testing Specimens Related to Possible Sexual Assault or Abuse 2002  Culture is the recommended method for detecting C. trachomatis and N. gonorrhoeae in urogenital, pharyngeal, and rectal specimens 2011  NAATs are the recommended method for detecting C. trachomatis and N. gonorrhoeae in urogenital specimens Some NAATs report cross-reaction with non-gonococcal Neisseria species and these may require repeat testing by an alternative method  Limited data on the use of NAATs with pharyngeal and rectal specimens from children

14. Consultants Stefanie Akselrod FDA Julius Schachter University of California James Beebe PHL, San Luis Obispo Steven Shapiro CDC Gary Budnick Connecticut Dept of PHL Shari Shea APHL Joan Chow CA Dept of Public Health Melissa Singer CMS George Dizikes Illinois Dept of PHL Rick Steece National IPP Program Yetty Fakile CDC Lisa Steele CDC Dennis Ferrero CA Assoc. of PHL Directors Bobbie Van der Pol Indiana University School of Medicine Charlotte Gaydos Johns Hopkins University Katherine Whitaker FDA Tom Gift CDC Dean Willis Florida Bureau of Laboratories Sarah Guerry LA County DOH Medical Director Kelly Wrobleswski APHL Bob Johnson CDC Scott Zimmerman Erie County PHL Guideline writing Team

15. Overview of the APHL / CDC STD Steering Committee  Priority: Development of new Testing Guidelines for CT, GC and Syphilis Expansion Continue to monitor the progress of guidelines development Develop and distribute communications once guidelines are released of rectal and pharyngeal testing for CT/GC using NAATs  Priority: Assessment of PHL STD capabilities, capacity and practice Develop survey tool Launch Survey January 2011  Priority: Develop a Green Paper on the Role of PHLs in STD Testing Draft a Green Paper that addresses the issue of privatization of STD testing and question of what role PHLs will play in STD testing in the future. Address feedback from the ID Committee and BOD Determine committee response based on feedback

16. Overview of the APHL / CDC STD Steering Committee  Priority: Development of Herpes Testing Guidelines Identify a workgroup to develop key questions regarding Herpes test methods and testing practices. Perform a literature review of existing data that would answer those questions. Determine what additional data would be needed to adequately answer the key questions  Assist Interested Laboratories in the Implementation of Use of Off-label NAAT for CT/GC in non-genital anatomic sites Monitor the development of a verification panel for the BD assay and assist when possible. Point interested laboratories to the checklist  Priority: Development of Trichomonas Testing Guidelines Item pending until development of Herpes guidelines underway

17. Laboratory Evolution