CDC Laboratory Update
Chlamydia and Gonorrhea Laboratory Guidelines
Overview of the APHL / CDC STD Steering Committee
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
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
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
Meeting Summary:Performance Characteristics
All culture and non-culture tests may generate false-positive results Clinician education
Nucleic acid amplification tests (NAATs) have superior performance to all other tests Performance characteristics comparisons will be based on published data These are the tests labs should be using to detect CT and GC regardless of
presentation
Culture is still useful in certain circumstances GC susceptibility testing Detect mutant strains Should be maintained
Meeting Summary:Performance Characteristics
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
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.
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
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
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
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
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
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
Consultants
Stefanie AkselrodFDA
Julius SchachterUniversity of California
James BeebePHL, San Luis Obispo
Steven ShapiroCDC
Gary BudnickConnecticut Dept of PHL
Shari SheaAPHL
Joan ChowCA Dept of Public Health
Melissa SingerCMS
George DizikesIllinois Dept of PHL
Rick SteeceNational IPP Program
Yetty FakileCDC
Lisa SteeleCDC
Dennis FerreroCA Assoc. of PHL Directors
Bobbie Van der PolIndiana University School of Medicine
Charlotte GaydosJohns Hopkins University
Katherine WhitakerFDA
Tom GiftCDC
Dean WillisFlorida Bureau of Laboratories
Sarah GuerryLA County DOH Medical Director
Kelly WrobleswskiAPHL
Bob JohnsonCDC
Scott ZimmermanErie County PHL
Guideline writing Team
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
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
Laboratory Evolution