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Sexually Transmitted Diseases

ChlamydiaScreening Tests To Detect Chlamydia trachomatis and Neisseria gonorrhoeae Infections - 2002


Appendix B

Indications for Neisseria gonorrhoeae Testing and Test Selection by Specimen Type

Readers are cautioned to refer to the manufacturers' test kit inserts for specific details. Information in this appendix represents general conditions for comparative purposes.

Endocervical swabs/urethral swabs from males

Indication

  • Screening
    • Females: When pelvic examination is indicated
    • Males: Urine might be more acceptable to asymptomatic males
  • Endocervicitis
  • Urethritis (males)
  • Diseases at other anatomic locations possibly caused by sexually acquired N. gonorrhoeae infection
    • Pelvic inflammatory disease
    • Urethral syndrome
    • Bartholinitis
    • Epididymitis
    • Perihepatitis (Fitz-Hugh-Curtis syndrome) (females)
    • Proctitis
    • Disseminated gonococcal infections
    • Conjunctivitis
  • Not recommended for prepubertal children

Test selection

  • Gram-stained smear as a point-of-care test for males with urethral discharge
    • For males with urethral discharge, the sensitivity and specificity are similar to culture with oxidase testing and Gram-staining of any colonies with N. gonorrhoeae morphology
    • Culture after a positive Gram-stained smear might be useful for quality assurance, but additional testing is not usually otherwise indicated
  • Culture
    • Preferred if ambient conditions during holding and transport of inoculated media are adequate to maintain the viability of organisms
      Sensitivity and specificity of culture with additional testing approaches or surpasses that of other tests
      A culture isolate should be tested for antimicrobial resistance if a patient fails therapy
      Culture allows monitoring for antimicrobial resistance
  • Nucleic acid amplification tests (NAATs) or nucleic acid hybridization tests
    • Recommended when conditions during holding and transport of inoculated culture media are not adequate to maintain the viability of organisms
    • Commercial polymerase chain reaction (PCR)* and strand displacement assays ; have cross-reacted with nongonococcal Neisseria; such cross-reactivity has not been reported for commercial ligase chain reaction (LCR) and unamplified probe assays
  • Additional testing is recommended after an initial positive screening test if a low positive predictive value can be expected or if a false-positive result would have serious psychosocial or legal consequences
Urine

Indication

  • Males: Screening
  • Females: Screening when pelvic examination is not indicated

Test selection

  • NAATs
  • Sensitivity with urine might be lower than with urethral (males) or endocervical swabs §
  • Other tests are not recommended because of low sensitivity
  • Additional testing is recommended after an initial positive screening test if a low positive predictive value can be expected because of a low prevalence or if a false-positive result would have serious psychosocial or legal consequences
Vaginal swabs, postmenarcheal adolescents and adults

Indication

  • Screening/testing of women when pelvic examination is not otherwise indicated

Test selection

  • No test is recommended for use with vaginal swab specimens
  • The Food and Drug Administration (FDA) has not cleared any nonculture test for use with vaginal specimens
  • NAAT

    Additional review is needed before a recommendation can be made; however, in one study, sensitivity and specificity with a provider- or client-collected vaginal swab was similar to screening with endocervical or urine specimens

    Additional testing is recommended after an initial positive screening test if a low positive predictive value can be expected or if a false-positive result would have serious psychosocial or legal consequences

  • Culture

    Not recommended for adults because of suboptimal sensitivity

  • Other tests are not recommended because of low sensitivity
Vaginal swabs, prepubescent females

Indication

  • Possible sexual abuse, children

Test selection

  • Culture
    • Preferred for possibly sexually abused children because of presence of vaginal epithelium that is susceptible to N. gonorrhoeae infection, high specificity, and ability to retain isolate for additional testing
  • FDA has not cleared any nonculture test for use with vaginal specimens
  • NAATs
    • When culture is not available, certain specialists support use of a NAAT if a positive result can be verified by another NAAT
  • Other tests are not recommended because of low sensitivity and specificity
Rectal swabs

Indication

  • Patients with history of receptive anal intercourse
  • Proctitis
  • Possible sexual abuse, children

Test selection

  • Culture
    • Preferred

      The sensitivity of culture is not well-defined; isolates that are oxidase-positive and Gram-negative diplococci should receive additional testing to verify an initial presumptive N. gonorrhoeae diagnosis, if a false-positive result would have serious medical, psychosocial, or legal consequences

      A culture isolate should be tested for antimicrobial resistance if a patient fails therapy

  • Other tests are not recommended
Pharyngeal swabs

Indication

  • Patients concerned regarding exposure during fellatio or cunnilingus
  • Newborn or infant (nasopharyngeal specimens)
    • Neonatal conjunctivitis
  • Possible sexual abuse, children

Test selection

  • Culture
    • Preferred method

      Sensitivity of culture for pharyngeal specimens is not well-defined

      Isolates that are oxidase-positive and contain Gram-negative diplococci should receive additional testing to verify an initial presumptive N. gonorrhoeae diagnosis because of the common occurrence of nongonococcal Neisseria in the pharynx

      A culture isolate should be tested for antimicrobial resistance if a patient fails therapy

  • Other tests are not recommended
Conjunctival swabs

Indication

  • Conjunctivitis among adults
  • Newborn or infant
    • Neonatal conjunctivitis

Test selection

  • Gram stain as point-of-care test
    • Recommended to establish a presumptive diagnosis of N. gonorrhoeae during a patients visit for conjunctivitis
    • Adequate sensitivity because of high concentration of organisms
    • Gram stain should be followed by laboratory-based testing because Gram-negative diplococci other than N. gonorrhoeae are occasionally isolated from conjunctiva
  • Culture
    • Preferred

      High sensitivity because of high concentration of organisms

      Oxidase-positive and Gram-stain positive bacteria other than N. gonorrhoeae occasionally isolated from conjunctiva

      Inoculation onto nonselective media might increase sensitivity

  • Only a limited number, if any, nonculture tests are FDA-cleared for conjunctival specimens
Diagnosing disseminated gonococcal infection, adults or neonates
 

Test selection

  • Gram stain as point-of-care test
    • Recommended on any synovial fluid and cerebrospinal fluid collected for other tests and on endocervical and urethral swab specimens
    • Gram stain should be followed by laboratory-based testing, which is ore sensitive and specific
  • Culture
    • Preferred
    • Blood, synovial fluid from affected joints, and, if indicated, cerebrospinal fluid specimens should be inoculated onto nonselective as well as selective medias
    • Swab specimens from the endocervix (adult female), vagina (neonate), urethra (adult male), rectum, and pharynx should be inoculated onto selective media
    • Additional testing recommended after an initial positive test to verify diagnosis
  • No other tests are recommended

* Source: Martin DH, Cammarata C, Van der Pol B, et al. Multicenter evaluation of AMPLICOR and automated COBAS AMPLICOR CT/NG tests for Neisseria gonorrhoeae. J Clin Microbiol 2000;38:3544-9.

Source: Becton Dickinson.  BDProbeTec ™ ET Chlamydia trachomatis and Neisseria gonorrhoeae amplified DNA assays [Package insert]. Sparks, MD: Becton Dickinson, 2001.

§ Sources: Martin DH, Cammarata C, Van der Pol B, et al. Multicenter evaluation of AMPLICOR and automated COBAS AMPLICOR CT/NG tests for Neisseria gonorrhoeae. J Clin Microbiol 2000;38:3544-9. Crotchfelt KA, Welsh LE, DeBonville D, Rosenstraus M, Quinn TC. Detection of Neisseria  gonorrhoeae and Chlamydia trachomatis in genitourinary specimens from men and women by a coamplification PCR assay. J Clin Microbiol 1997;35:1536-40.

Source: Hook EW III, Ching SF, Stephens J, Hardy KF, Smith KR, Lee HH. Diagnosis of Neisseria gonorrhoeae infections in women by using the ligase chain reaction on patient-obtained vaginal swabs. J Clin Microbiol 1997;35:2129-32.