NEISSERIA GONORRHOEAE NUCLEIC ACID by TMA

Test Documentation
Specimen Required
Specimen source required for testing.
Endocervical, vaginal or male urethral swab specimens in APTIMA Combo II transport medium.
First catch urine in APTIMA Combo II Urine Transport Tube. Liquid level must fall between the two black indicator lines. Minimum 2.0 mL urine in sterile specimen cup.
Dedicated specimens are required. If Chlamydia and Neisseria are both ordered on sample may be sent. Specimens used in other assays will not be tested.

Alternate Specimen
First catch urine in sterile specimen cup. Minimum 5.0 mL
Endocervical, vaginal or male urethral swab in M4 and M5 viral transport tube- 0.4 mL minimum
Endocervical, vaginal or male urethral swab in Gen-Probe Pace 2 swab transport tubes-0.4 mL minimum
Endocervical, vaginal or male urethral swab in BD ProbeTec ET CT/GC Diluent- 0.4 mL minimum
Endocervical, vaginal or male urethral swab in BD ProbeTec Dry Swab system

Rejection Criteria
Specimens submitted with the white cleaning swab or with two swabs. Transport tubes without swabs. Swabs in gel, wooden swabs, dry swabs other than BD Dry Swab system. Swabs in bacterial transport medium (e.g., culturettes). Urine specimens where the liquid level in the urine transport tube does not fall between the two black indicator lines. Urine specimens in sterile containers that have exceeded the 24 hour stability. Specimens collected in liquid cytology containers or media will not be tested.
Specimens collected in Universal Transport Medium (UTM)

Methodology
Transcription Mediated Amplification (TMA). Positive specimens are retested using a different TMA assay (different target) before reporting.
The analytical sensitivity of the Neisseria gonorrhoeae assay is 362 organisms per swab or 250 organisms per milliliter of urine.

Stability
Swab in APTIMA Combo II transport medium
Urine in APTIMA Combo II urine transport tube
Room Temperature: 30 days
Refrigerated: 30 days
Frozen -20°C: 90 days
Urine in an IATA sterile screw-capped plastic container. ( For increased stability, transfer urine sample to APTIMA Combo II Urine transport tube within 24 hours of collection.) If sending a primary urine, transfer urine to a sterile IATA-approved screw-topped plastic container.
Refrigerated: 24 hours
Room temperature: Not Recommended
Frozen -20°C: 4 days
Swab in M4 and M5 Viral Transport tube
Refrigerated: 4 days
Room temp: 24 hours
Frozen -20°C: 4 days
Swab in Gen-Probe Pace 2 swab transport tubes
Room Temperature: 7 days
Refrigerated: 7 days
Frozen -20°C: Not Recommended
Swab in BD ProbeTec ET CT/GC Diluent
BD ProbeTec Dry Swab
Room Temperature: 4 days
Refrigerated: 4 days
Frozen -20°C: Not Recommended

Reference Range
Not detected

Performed
Sunday-Thursday

Turnaround Time2 days
Test CodeGCRNA
CPT-4 Code (s)
87591
LOINC Codes
Source   31208-2  
N. gonorrhaeae   5028-6  

Warde
Medical
Laboratory