Test Code SCGCT Neisseria gonorrhoeae, Self-Collect, Nucleic Acid Amplification, Throat
Specimen Required
Only orderable as part of a profile. For more information see: SCCGT/ Chlamydia trachomatis and Neisseria gonorrhoeae, Self-Collect, Amplified RNA, Throat
Specimen Type: Oropharynx/pharynx/throat
Supplies: Aptima Throat Swab Self-Collection Kit (T1002)
Container/Tube: Aptima Multitest Swab
Specimen Volume: Swab
Collection Instructions:
1. Specimens must be collected in a healthcare setting by the patient using the Aptima Multitest Swab (provided in T1002 or available separately).
2. Provide patient with the Aptima Throat Swab Self-Collection Kit or Aptima Multitest Swab and collection instructions.
3. Instruct patient to collect the specimen following the instructions provided and then return swab to the healthcare professional once complete.
4. Once patient returns the specimen, ensure the tube is securely capped, and label tube with patient's entire name and collection date and time.
5. Maintain swab container at either 4 to 30° C (refrigerated temperature is preferred) or -20 to -70° C, and transport within 60 days of collection.
Useful For
Detecting Neisseria gonorrhoeae using throat swabs collected by the patient in a healthcare setting
This test is not intended for use in medico-legal applications.
Method Name
Only orderable as part of a profile. For more information see SCCGT/ Chlamydia trachomatis and Neisseria gonorrhoeae, Self-Collect, Amplified RNA, Throat
Transcription-Mediated Amplification
Reporting Name
N gonor, RNA, SelfCollect, ThroatSpecimen Type
VariesSpecimen Minimum Volume
See Specimen Required
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Varies | Refrigerated (preferred) | APTIMA VIAL | |
Ambient | APTIMA VIAL | ||
Frozen | APTIMA VIAL |
Reject Due To
Transport tubes containing a cleaning swab or more than 1 swab | Reject |
No swab present in Aptima vial | Reject |
Clinical Information
Gonorrhea is caused by the bacterium Neisseria gonorrhoeae. It is a very common sexually transmitted infection (STI) with over 677,000 cases of gonorrhea reported to the Centers for Disease Control and Prevention (CDC) in 2020. Like chlamydia, many infections in women are asymptomatic, and the true prevalence of gonorrhea is likely much higher than reported. The organism causes genitourinary infections in women and men and may be associated with dysuria as well as vaginal, urethral, or Throat discharge. Complications include pelvic inflammatory disease in women and gonococcal epididymitis and prostatitis in men. Gonococcal bacteremia, pharyngitis, and arthritis may also occur. Infection in men is typically associated with symptoms that would prompt clinical evaluation. Given the risk for asymptomatic infection in women, screening is recommended for women at increased risk of infection (eg, women with previous gonorrhea or other STIs, inconsistent condom use, new or multiple sex partners, and women in certain demographic groups, such as those in communities with high STI prevalence). The CDC currently recommends dual antibiotic treatment due to emerging antimicrobial resistance.
Culture was previously considered to be the gold standard test for diagnosis of Chlamydia trachomatis and N gonorrhoeae infections. However, these organisms are labile in vitro; therefore, precise specimen collection, transportation, and processing conditions are required to maintain organism viability, which is necessary for successful culturing. In comparison, nucleic acid amplification testing (NAAT) provides superior sensitivity and specificity and is now considered the reference standard method for diagnosis in most cases. Immunoassays and nonamplification DNA tests are also available for C trachomatis and N gonorrhoeae detection, but these methods are significantly less sensitive and less specific than NAAT.
Improved screening rates and increased sensitivity of NAAT have resulted in an increased number of accurately diagnosed cases. Improved detection rates result from improved performance characteristics of the assays and patients' easy acceptance of urine testing. Early identification of infection enables sexual partners to seek testing and/or treatment as soon as possible and reduces the risk of disease spread. Prompt treatment reduces the risk of infertility in women.
Reference Values
Only orderable as part of a profile. For more information see: SCCGT/ Chlamydia trachomatis and Neisseria gonorrhoeae, Self-Collect, Amplified RNA, Throat
Negative
Day(s) Performed
Monday through Sunday
Report Available
1 to 4 daysPerforming Laboratory
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Test Classification
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
87591