Laboratory Recommendations for the Detection of Chlamydia trachomatis, Neisseria gonorrhoeae

Top Changes from 2002 Guidelines

(besides the title)

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.

2010 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

2010 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.

2010 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

– www.aphl.org/aphlprograms/infectious/std/Documents/NAATRectalSwabs.pdf

– These are not prescriptive and must be reviewed by local CLIA surveyors

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.

2010 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

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%).

2010 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

2010 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