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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.


Secondary ID

621939

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

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

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

Interpretation

A positive result indicates the presence of nucleic acid from Neisseria gonorrhoeae and strongly supports the diagnosis of gonorrheal infection.

 

A negative result indicates the absence of N gonorrhoeae nucleic acid. A negative result does not exclude the possibility of infection. If clinical indications strongly suggest gonococcal or chlamydial infection, additional specimens should be collected for testing.

 

A result of inconclusive indicates that a new specimen should be collected.

 

The predictive value of an assay depends on the prevalence of the disease in any specific population. In settings with a high prevalence of sexually transmitted infections, positive assay results have a high likelihood of being true-positive results. In settings with a low prevalence of sexually transmitted infections, or in any settings in which a patient's clinical signs and symptoms or risk factors are inconsistent with gonococcal urogenital infection, positive results should be carefully assessed, and the patient retested by other methods (eg, culture for N gonorrhoeae) if appropriate.

Method Description

The HOLOGIC Aptima Combo 2 Assay combines the technologies of target capture, transcription-mediated amplification, and dual kinetic assay. The detection of the ribosomal RNA amplification product sequences (amplicon) is achieved using nucleic acid hybridization. Single-stranded chemiluminescent DNA probes are labeled and combine with amplicon to form stable RNA:DNA hybrids. Light emitted from the labeled RNA:DNA hybrids is measured as photon signals in a luminometer.(Package insert: Aptima Combo 2 Assay, AW-25929-001. Hologic, Inc; Rev 002, 06/2023)

Day(s) Performed

Monday through Sunday

Report Available

1 to 4 days

Specimen Retention Time

7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87591

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SCGCV N gonor, RNA, SelfCollect, Vagina 43305-2

 

Result ID Test Result Name Result LOINC Value
621939 Neisseria gonorrhoeae amplified RNA 43305-2