CDC Laboratory Update

Transcription

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, Neisseria gonorrhoeae Top Changes from 2002 Guidelines (besides the title)

3 CT / GC Recommendations: Infections of the Reproductive Tract (Female) 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. 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

4 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

5 CT / GC Recommendations: Rectal and Pharyngeal Infections (CT) Culture performed on rectal or pharyngeal swab specimens; a C. trachomatis-major outer membrane protein (MOMP)-specific stain should be used. A nucleic acid amplification test (NAAT) performed on a rectal swab NAATs are not cleared for rectal specimens by the FDA CDC funded an external specimen bank to facilitate an off-label establishment study Protocol and guidelines developed by the APHL/CDC STD Steering Committee df These are not prescriptive and must be reviewed by local CLIA surveyors Too few pharyngeal CT infections for a meaningful comparison

6 CT / GC Recommendations: Rectal and Pharyngeal Infections (GC) 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. A nucleic acid amplification test (NAAT) performed on a rectal or pharyngeal swab NAATs are not cleared for these specimen types by the FDA Some NAATs report cross-reaction and these may require repeat testing by an alternative method CDC funded an external specimen bank to facilitate an off-label establishment study Protocol and guidelines developed by the APHL/CDC STD Steering Committee Culture performed on rectal or pharyngeal swab specimens when there is a need to assess GC isolates for resistance to front line antibiotics

7 CT / GC Recommendations: Supplemental Testing 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%). 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

8 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

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10 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

11 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

12 Laboratory Evolution