Neisseria gonorrhoeae, Miscellaneous Sites, Nucleic Acid Amplification, Varies
Use
This test is useful for detecting Neisseria gonorrhoeae in non-US Food and Drug Administration-approved specimen types. It is intended for non-FDA-approved specimen types such as ocular swabs and peritoneal fluid. Gonorrhea, caused by Neisseria gonorrhoeae, is a common sexually transmitted infection with significant rates of asymptomatic cases, particularly in women. The test provides a highly sensitive and specific method for diagnosis, using nucleic acid amplification testing (NAAT), which is considered the reference standard for diagnosing N. gonorrhoeae infections.
Special Instructions
Specimen source is required for testing. Only one of the specified specimens should be submitted, and specimens must be collected using designated Aptima collection kits. This test is not intended for use in medico-legal applications. Also, a Microbiology Test Request form should be completed and sent with the specimen if not ordered electronically.
Limitations
A negative test result does not exclude the possibility of infection. Improper specimen collection, concurrent antibiotic therapy, presence of inhibitors, or low organism numbers may lead to false-negative results. In low-prevalence populations, positive results must be interpreted carefully as false positives may be more frequent than true positives. The test performance characteristics were determined by Mayo Clinic but have not been cleared or approved by the FDA.
New York Approved
Methodology
PCR-based
Biomarkers
LOINC Codes
- 43305-2
- 43305-2
- 31208-2
Result Turnaround Time
1-4 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
1 Swab
Minimum Volume
Not provided
Container
Aptima Multitest Swab or Aptima Collection Unisex Swab
Collection Instructions
Swab site using Aptima Multitest Swab or Aptima Collection Unisex Swab. Place collection swab in transport tube provided in collection kit. Snap off swab at score line so it fits into the closed tube. Cap tube securely and label tube with patient's entire name and collection date and time. Maintain swab container at 2 to 30 degrees C, transport within 60 days of collection.
Storage Instructions
Maintain swab container at 2 to 30 degrees C (refrigerated temperature is preferred),
Causes for Rejection
Multiple sources on single tube; Fluid collected in ThinPrep vial prior to aliquot into Aptima Transfer Tube