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Test Code SCGCV Neisseria gonorrhoeae, Self-Collect, Amplified RNA, Vaginal


Specimen Required


Only orderable as part of a profile. For more information see SCCGV / Chlamydia trachomatis and Neisseria gonorrhoeae, Self-Collect, Amplified RNA, Vaginal.

 

Specimen Type: Vaginal

Supplies: Aptima Vaginal Swab Self-Collection Kit (T1001)

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 T1001 or available separately).

2. Provide patient with the Aptima Vaginal 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 2 to 30° C (refrigerate temperature is preferred) and transport within 60 days of collection. If longer storage is needed, freeze at -20 to -70° C for up to 12 months.


Useful For

Detecting Neisseria gonorrhoeae using vaginal 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 SCCGV / Chlamydia trachomatis and Neisseria gonorrhoeae, Self-Collect, Amplified RNA, Vaginal.

 

Transcription Mediated Amplification

Reporting Name

N gonor, RNA, SelfCollect, Vagina

Specimen Type

Varies

Specimen 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 rectal 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 SCCGV / Chlamydia trachomatis and Neisseria gonorrhoeae, Self-Collect, Amplified RNA, Vaginal.

 

Negative

Day(s) Performed

Monday through Sunday

Report Available

1 to 4 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87591