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