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
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.