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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, Throat

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: SCCGT/ Chlamydia trachomatis and Neisseria gonorrhoeae, Self-Collect, Amplified RNA, Throat

 

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.

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 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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SCGCT N gonor, RNA, SelfCollect, Throat 43305-2

 

Result ID Test Result Name Result LOINC Value
621933 Neisseria gonorrhoeae amplified RNA 43305-2