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Test Code LAB2097 Neisseria Gonorrhea Detection by DNA Probe (Amplified)

Additional Codes

STD GC

Includes:

Identification of Neisseria gonorrhea RNA in urine, vaginal swab, cervical swab, or urethral swab.

Collection:

Urethral and Endocervical:   Collect urethral & endocervical swabs using Aptima (Gen-Probe) Unisex transport kit. The white cleaning swab must be discarded. Collect specimen with the blue swab and place the blue swab in the tube. Store and transport tubes either refrigerated or at room temp up to one week.

 

Urine: Collect first catch urine in sterile container and transfer to Aptima (Gen-Probe) Urine transport tube within 24 hrs. Fill transport tube with urine so volume falls between the two black lines in the window of the tube.  Store and transport tubes either refrigerated or at room temp up to one week. Urine specimens from females are acceptable but are not FDA-approved. The patient should not have urinated for at least 1 hour prior to specimen collection. Female patients should not cleanse the labial area prior to providing the specimen.  

 

Throat, Rectal, Eye: Collect swab using the Aptima Unisex transport kit. Collect specimen with the blue swab. Pleace the blue swab in the tube. These specimen types are acceptable but not FDA approved.

 

UNACCEPTABLE/REJECTED SPECIMENS:

  • No Swab in tube
  • White swab in tube
  • Culturette
  • Clean catch urines or any sources other than listed above
  • Overfilled or Underfilled Urine collection tube

 

Storage Instructions:

Send specimen to Lab within one week, room temp or refrigerated.

Turnaround Time (TAT):

Results are reported on the day test is performed.

Send To:

UMC Main Laboratory Specimen Receiving - EH319 Hospital Extension

Reference Interval:

Negative

Performed in

UMC Main Lab - Molecular Pathology

Interpretive Data

This assay has been FDA-cleared for the following specimens:

  • Clinician-collected endocervical, vaginal, and male urethral swab specimens (collected with the APTIMA Unisex Swab Specimen Collection Kit)
  • Male urine specimens (collected with the APTIMA Urine Collection Kit).

It has NOT been evaluated in adolescents less than 14 years of age. The assay utilizes target capture and transcription-mediated amplification for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria Gonorrhea (GC). Therapeutic failure or success cannot be determined with this test since nucleic acid may persist following appropriate antimicrobial therapy.

Result Interpretation:

Positive: organism is detected

Negative: organism is not detected

Equivocal: The amplified DNA Probe for Neisseria Gonorrhea was borderline. This may be due to a low amount of organisms in the sample or to the presence of dead organisms post treatment. Recollection is recommended.

 

Request Form

Routine Laboratory Request Form

Assay

N/A