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BOX 1. Summary of recommendations

  • Nucleic acid amplification tests (NAATs) that are cleared by the Food and Drug Administration (FDA) are recommended for detection of genital tract infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae infections in men and women with and without symptoms. For detecting these infections of the genital tract, optimal specimen types for NAATs are vaginal swabs from women and first catch urine from men. Older nonculture tests and non-NAATs have inferior sensitivity and specificity characteristics and no longer are recommended.
  • NAATs have not been cleared by FDA for the detection of rectal and oropharyngeal infections caused by C. trachomatis and N. gonorrhoeae. CDC is recommending NAATs to test for these extragenital infections based on increased sensitivity, ease of specimen transport and processing. Because these specimen types have not been cleared by FDA for use with NAATs, laboratories must establish performance specifications when using these specimens to meet Clinical Laboratory Improvement Amendments (CLIA) regulatory requirements and local or state regulations as applicable prior to reporting results for patient management. Positive reactions with nongonococcal Neisseria species have been reported with some NAATs, particularly with oropharyngeal specimens. Alternate target testing using NAATs without reported crossreactivity might be needed to avoid false positive gonorrhea results when using these tests with these specimens.
  • Routine repeat testing of NAAT-positive genital tract specimens is not recommended because the practice does not improve the positive predictive value of the test.
  • Laboratory interpretation of test results should be consistent with product inserts for FDA-cleared tests or have met all federal and state regulations for a modified procedure if the laboratory has changed the cutoff values or testing algorithm. This approach provides the most appropriate information to the clinician, who is ultimately responsible for assessing test results to guide patient and partner management.
  • N. gonorrhoeae culture capacity is still needed for evaluating suspected cases of treatment failure and monitoring antimicrobial susceptibility.
  • C. trachomatis and N. gonorrhoeae culture capacity might still be needed in instances of child sexual assault in boys and extragenital infections in girls.

BOX 2. Chlamydia trachomatis and Neisseria gonorrhoeae testing in women

  • Nucleic acid amplification tests (NAATs) are the recommended test method.
  • A self- or clinician-collected vaginal swab is the recommended sample type. Self-collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated.
  • An endocervical swab is acceptable when a pelvic examination is indicated.
  • A first catch urine specimen is acceptable but might detect up to 10% fewer infections when compared with vaginal and endocervical swab samples.
  • An endocervical swab specimen for N. gonorrhoeae culture should be obtained and evaluated for antibiotic susceptibility in patients that have received CDC-recommended antimicrobial regimen as treatment, and subsequently had a positive N. gonorrhoeae test result (positive NAAT ≥7 days after treatment), and did not engage in sexual activity after treatment.

BOX 3. Chlamydia trachomatis and Neisseria gonorrhoeae testing in men

  • Nucleic acid amplification tests (NAATs) are the recommended test method.
  • A first catch urine is the recommended sample type and is equivalent to a urethral swab in detecting infection.
  • A urethral swab specimen for N. gonorrhoeae culture should be obtained and evaluated for antibiotic susceptibility in patients who have received [CDC-recommended antimicrobial] regimen as treatment, and subsequently had a positive N. gonorrhoeae test result (positive NAAT ≥7 days after treatment), and did not engage in sexual activity after treatment.

BOX 4. Detection of Chlamydia trachomatis and Neisseria gonorrhoeae infections in therectum and oropharynx

  • Nucleic acid amplification tests (NAATs) are the recommended test method for rectal and oropharyngeal specimens.
  • Laboratories must be in compliance with CLIA for test modifications since these tests have not been cleared by the FDA for these specimen types.
  • Commensal Neisseria species commonly found in the oropharynx might cause false positive reactions in some NAATs, and further testing might be required for accuracy.
  • A rectal or oropharyngeal swab specimen for N. gonorrhoeae culture should be obtained and evaluated for antibiotic susceptibility in patients who have received CDC-recommended antimicrobial regimen as treatment, had a subsequent positive N. gonorrhoeae test result (positive NAAT ≥7 days after treatment), and did not engage in sexual activity after treatment.

[Link to free full-text MMWR article online]

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