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:
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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 falsepositive 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 falsepositive 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 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
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