Clinical Information

N. gonorrhoeae is the causative agent of gonococcal (GC) infections, the majority of which are uncomplicated lower genital tract infections and may be asymptomatic.  However, if left untreated in women, infections can ascend and cause PID which can manifest as endometriosis, salpingitis, pelvic peritonitis, and tubo-ovarian abscesses.  A smaller percentage of persons with gonococcal infections may develop disseminated Gonococcal Infection.

Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution, APTIMA vaginal swabs, APTIMA endocervical unisex swabs, and male and female urine specimens from symptomatic and asymptomatic individuals are approved for testing.  Other specimen types are not acceptable.

Improper collection of the specimen may results in invalid results.  If the lab receives a swab specimen transport tube with no swabs, two swabs, a cleaning swab, or a swab not supplied by Hologic the specimen must be rejected.

A negative test result does not preclude the presence of a GC infection because results are dependent on adequate specimen collection, absence of inhibitors, and sufficient rRNA to be detected.

If a specimen has small numbers of GC cellular material, uneven distribution may occur which may affect the ability to detect small numbers of organisms in the collected material.  If negative results from the specimen do not fit with the clinical impression, a new specimen may be necessary.

Results for GC will be reported as Positive, Negative (presumed negative for GC rRNA) or Equivocal.  For specimens giving an Equivocal (indeterminate) result, a new specimen should be collected.