Neisseria gonorrhoeae, Nucleic Acid Amplification, Varies
Use
Detecting Neisseria gonorrhoeae. Gonorrhea is caused by the bacterium Neisseria gonorrhoeae, which is a common sexually transmitted infection. Many infections, especially in women, are asymptomatic, making screening important in high-risk groups. The test uses nucleic acid amplification, which is more sensitive and specific compared to culture and other testing methods. Early detection enables prompt treatment and prevents disease spread, reducing potential complications such as infertility in women.
Special Instructions
This test is not intended for use in medico-legal applications. Specimen source is required for testing. The test requires proper specimen collection and handling to maintain organism viability. Additionally, this test is not to be used as a measure of therapeutic success or failure.
Limitations
Test results must be considered alongside clinical evaluation and other laboratory data. A negative test result does not exclude infection, as improper collection, low organism numbers, or presence of inhibitors may lead to false negatives. Positive results in low-prevalence populations should be interpreted cautiously due to the risk of false positives. The test performance has not been evaluated in individuals under 14 years or pregnant women for certain specimen types.
FDA ApprovedNew York Approved
Methodology
PCR-based
Biomarkers
LOINC Codes
- 43305-2
- 31208-2
- 43305-2
Result Turnaround Time
1-4 days
Related Documents
For more information, please review the documents below
Specimen
Cervical Swab
Volume
1 Swab
Minimum Volume
Not provided
Container
Aptima Unisex Swab
Collection Instructions
Collect using the Aptima Unisex Swab Collection Kit, ensuring proper swab insertion and handling. Maintain swab at 2 to 30°C and transport within 60 days.
Storage Instructions
Refrigerated temperature preferred; freeze if longer storage required.
Causes for Rejection
Improperly filled tubes, multiple sources in a single tube.